VivoScene

May 2021 Issue

Learn about the capabilities of OCT in clinical and research applications. The CEO of Michelson Diagnostics, Jon Holmes, will present at the upcoming annual, virtual meeting of the American Society for Laser Medicine & Surgery (ASLMS), May 15 – 17, 2021:

10 YEARS OF OPTICAL COHERENCE TOMOGRAPHY IN DERMATOLOGY: A REVIEW OF PROGRESS MADE IN CLINICAL UTILITY AND IN SKIN RESEARCH APPLICATIONS 2010-2020

When: Sunday, May 16, 2021 from 2:32 PM – 2:45 PM CDT 

Where: NON-CME Industry White Paper Presentations – Session #2

What: 10 minutes recorded presentation and PDF, followed by Live Q & A

Who: Jon Holmes MA, FInstP, FASLMS – CEO & Co-Founder, Michelson Diagnostics Ltd.

ASLMS Virtual Meeting: May 15 - 17, 2021
ASLMS Virtual Meeting: May 15 - 17, 2021

Management choices for Basal Cell Carcinoma (BCC) have been growing due to increased clinical research, treatment technology advances and use of state-of-the-art skin imaging systems. Flexible, efficient options that address each patients’ unique circumstances and preferences are desired. Leading physicians share their experience in the evolution of new management models and how VivoSight OCT plays a crucial role.

Christopher Zachary MD

“Besides established treatment methods for BCC, including Mohs micrographic surgery, new in-office, noninvasive therapies, like laser therapies, have achieved impressive results in recent studies for specific types of BCC lesions [1 – 8]”, says Christopher Zachary MD, Professor and Chair Emeritus of Dermatology at UC Irvine. 

He continues, “the integration of OCT skin imaging into treatment algorithms provides real insight into the optimal assessment, treatment and subsequent monitoring of lesions. The result will be increased patient convenience and practice efficiency. Initial cases are showing excellent clinical and aesthetic outcomes. We are studying OCT in combination with lasers to assess, treat and monitor the less aggressive BCC subtypes and see the following benefits:

Christopher Zachary, MD
Christopher Zachary, MD

Pre-Treatment Assessment

  • Determine peripheral extension and depth of lesion to provide unique and tailored treatment for better efficacy and cosmesis

Aiding Selection of Treatment Method

  • OCT assessment allows for effective lesion triage for appropriate treatment method selection, in consultation with the patient

Post-Treatment Monitoring

  • OCT-monitoring of the treated site allows optimal non-invasive postoperative assessment for possible recurrence and development of new tumors

Dr. Zachary concludes, “OCT adds a new layer of confidence about “what is going on & what we can do” due to new objective data and images. In fact, we just published a paper where we used an advanced laser technology (Sciton Inc.) to deliver a controlled hyperthermic dose to the lesion site in a precise fashion, guided by OCT lesion mapping [9] (Fig. 1 – 2).

Fig. 1: Exploring and homing in on new BCC management concepts: OCT assessment of lesion prior to treatment.
Fig. 2: Evaluation of clinical response from Sciton Nd:YAG laser treatment.
Fig. 2: Evaluation of clinical response from Sciton Nd:YAG laser treatment.

More work is to be done, but this project is a good illustration of the evolving OCT guided Assess-Treat-Monitor paradigm for the purpose of controlled, local therapy with satisfactory results for both patient and physician. The goal is to achieve high clearance rates with less invasive treatments that should offer superior cosmetic results to surgery.”

Orit Markowitz MD

In several cases new BCC management options are already integrated in real life clinical practice, a prominent example being OptiSkin in New York under the leadership of skin cancer specialist Orit Markowitz MD, the most veterened US pioneer dermatologist in Optical Coherence Tomography and founder of OptiSkin. Dr. Markowitz is also co-chairing the virtual second World Congress of Confocal Microscopy this month. Register here: RCM World Congress

In her newly opened multi-disciplinary center, Dr. Markowitz emphasizes a new model of care for non-melanoma skin cancer under the motto “Cutting Edge Without the Cutting TM”. She remarks, “of course there is room for excision and Mohs micrographic surgery, but I don’t cut, if I can help it. Technologies have come a long way and with them we can offer the latest methods in non-invasive skin cancer diagnosis, treatment and follow-up, a tailored approach our patients want” (Fig. 3).

Orit Markowitz, MD VIVOSIGHT OCT
Orit Markowitz, MD

Dr. Markowitz continues, “I’ve been treating non-melanoma skin cancer non-invasively for more than a decade now and we achieve clearance rates comparable to surgery. In a recent pilot study we achieved BCC clearance rates of over 82% from a single Nd:YAG laser treatment and 100% in up to three treatments [5].

I use RCM (Reflectance Confocal Microscopy) for non-melanoma skin cancer diagnosis, whereas OCT is used for pre-treatment margin assessment, deciding on treatment method based on margin and patient consultation, and monitoring for clearance after treatment. Our imaging modalities give us the information we need to let patients know that their lesions have been cleared, which is their primary concern.”

Dr. Markowitz concludes, “we use OCT also for post-treatment follow-up; if we see a BCC lesion not cleared, we simply re-treat, leading to our very high clearance rates. I’d like to further add that we also treat on the face for which OCT pre-margination is mandatory for targeted laser therapy with desirable cosmetic results. As many of our patient’s lesions are detected early in their evolution, these lesions might be particularly amenable to laser management”.

Julia Welzel MD & Uwe Reinhold MD

Two case examples from Germany, where VivoSight OCT is especially prevalent in dermatology practices: Dermatologists and OCT experts Julia Welzel MD and Uwe Reinhold MD have both independently conducted trials to validate safety and efficacy of OCT-guided scanning Nd:YAG laser treatment of BCC for utilization in clinical practice.

Julia Welzel MD, who is Chief of Dermatology at the University Hospital in Augsburg, Germany, states, “our team started investigating the OCTguided laser approach more than two years ago [12]. After fine tuning technique and parameters, we engaged in a study with positive results about to be published (Fig. 4 – 5). The advantages we see with the OCT-guided scanning Nd:YAG laser approach are:

  • A simple, potentially just single laser treatment for lesions less than 1 mm thick
  • Less morbidity than cryotherapy or surgery
  • More appropriate for elderly, infirm patients
  • An alternative to surgery
  • Cost and time savings. Much faster than PDT therapy or topical regimen with imiquimod.

This new approach has good potential to be well adopted in Germany.”

Fig. 4: Combined use of OCT skin imaging (left) and scanning Nd:YAG laser (Sciton, right) for BCC management.
Fig. 4: Combined use of OCT skin imaging (left) and scanning Nd:YAG laser (Sciton, right) for BCC management.
Fig. 5: (Left) 0.7 mm deep superficial BCC on left cheek before scanning Nd:YAG laser treatment. (Right) 6 month after single laser treatment. Clearance per OCT.
Fig. 5: (Left) 0.7 mm deep superficial BCC on left cheek before scanning Nd:YAG laser treatment. (Right) 6 month after single laser treatment. Clearance per OCT.

Uwe Reinhold MD is President of the Dermatology Center Bonn, in Bonn Germany, and is also an Executive Officer of the OnkoDerm physician network group focusing on skin cancer guidelines. “We are always on the lookout for new treatment options to provide more choices for our patients”, says Dr. Reinhold. “While it is under additional investigation in the US, we evaluated OCT-guided Nd:YAG laser therapy for appropriate BCC lesions for almost 2 years now and find it to be an excellent modality.” (Fig. 6 – 7).

He continues, “in Germany, treatment of BCC with PDT is very prevalent and achieves very good results especially as a field-directed therapy. However, the evolving scanning Nd:YAG laser from Sciton is attractive in more lesion-directed cases, and also as it is of very short duration compared to PDT. We’re excited to develop algorithms and treatment paths for various BCC presentations, based on our extensive preand post-treatment assessment with OCT, which is done routinely in Germany.”

Robert Stephens MD

Robert Stephens MD and his group at North West Sydney Dermatology & Laser are the first clinic in Australia to offer “OCT-guided skin cancer removal” (https://www.northwestderm.com.au). The team has a special interest in photodynamic therapy, the use of lasers and various types of light in the management of skin disorders, as well as surgical removal of skin cancers. Dr. Stephens has developed the interesting concept of “bi-phasic PDT”. The concept consists of using two types of light source to illuminate the photosensitized tumor. A first phase of conventional red-light activation is immediately followed by second phase delivery of light using an IPL device (Sciton BBL). The IPL is delivered with enough mechanical pressure in order to blanch the skin (to remove the blood).

Robert Stephens, MD VivoSight OCT
Robert Stephens, MD

The hypothesis is that hyperaemia/flushing from PDT can be detrimental as hemoglobin (particularly deoxyhemoglobin) can compete as a light absorber. Flushing can be beneficial though because more oxygen is delivered to tissue. Removing hemoglobin can dramatically augment the passage of light to tumor cells (including stronger yellow and green wavelengths included in the IPL spectrum) thus enhancing activation.

Sufficient free oxygen for the higher fluence second phase (IPL) activation is provided through hyperaemia/flushing from the first phase (red-light) activation. Mechanical pressure may also “squash” certain tumors thereby reducing the distance light has to travel to reach the lower edge.

Fig. 8: Flushing & Blanching: nodular BCC undergoing PDT on the left side of the nose. The flushing seen is following 5 minutes red light activation. (A) Blanching is demonstrated using the back surface of a curette overlying the tumor. This is quickly pulled away in (B) revealing the re-perfused tumor in (C).

Much improved outcomes with this method have been observed and first results have been published (there has been no clinical and/or OCT evidence of recurrence in 35 of 36 BCCs of which most tumors were facial and 50% were nodular). The mean follow-up time was 10 months [10]. (Fig. 8 – 11).

Fig. 9: Blanching of skin demonstration through pressure application from BBL handpiece tip.
Fig. 10: OCT image of 0.9 mm thick nodular BCC lesion with “squashable” liquefactive necrosis. Lesion thickness is reduced through compression with BBL handpiece during treatment.

For Dr. Stephens in Australia, OCT imaging combined with bi-phasic PDT makes it possible for “BCC diagnosis and removal the same day”. He says, “OCT is instrumental to assess if a skin cancer is suitable for PDT. It is invaluable for lesion selection where we determine depth and subtype of BCC, and further we can identify tumors showing features such as liquefactive necrosis that make them more “squashable” (with the Sciton BBL handpiece). Very important too is that we can verify lesion clearance with OCT.”

Dr. Stephens concludes, “we have an epidemic of BCC in Australia. Our patients want effective, efficient, non-invasive therapy options, as long as the lesion type allows it. For this, OCT serves as a patient qualification and outcome validation tool.”

In summary, a new era has evolved for more personalized, patient-driven management of BCC. VivoSight OCT imaging and measures enable investigators to advance the paradigm of OCT-guided Assessment, Treatment & Monitoring and aid in BCC lesion demarcation, appropriate treatment selection and clearance confidence. Precision skin imaging and innovative treatment methods are inseparable and complement each other for patient and practice efficient BCC management.

US FDA Regulatory Status:

The VivoSight™ topical OCT system is indicated for use in the two-dimensional, cross-sectional, real-time imaging of external tissues of the human body. This indicated use allows imaging of tissue microstructure, including skin, to aid trained and competent clinicians in their assessment of a patient’s clinical conditions. US Federal law restricts this device to sale by or on the order of a physician. VivoSight is cleared under 510(k) number K153283.

In close cooperation with the University Hospital of Augsburg, Germany and Michelson Diagnostics, our strategic partner DermoScan GmbH has developed a multi-session online course: OCT in Practice. This course we’ll cover in detail in our next newsletter (July). 

Using videos and documents, the course will cover 12 main topics (overview >> here), including, for example, when and how to ideally use OCT. You will learn how to assess the most common skin tumors based on typical visual criteria and receive helpful tips and explanations on OCT image interpretation. We also present rare or experimental OCT applications. Finally, test your knowledge in a quiz. Stay tuned! “OCT in Practice” coming soon to you!

Julia Welzel, MD presenting on VivoSight OCT image interpretation.
Julia Welzel, MD presenting on VivoSight OCT image interpretation.

May is Skin Cancer Awareness Month! There are now over 380 peer-reviewed publications covering VivoSight OCT and the most widely studied topic is imaging of Basal Cell Carcinoma. VivoSight serves as an aid to clinical diagnosis, and for measurement of tumor depth and lateral extent of the lesion. These capabilities can not only be helpful in guiding treatment decisions but are unmatched in the non-invasive monitoring of the treated site.

There are many additional publications on other skin cancer types. For a structured list of our publications, please see here

Differentiating Melanoacanthoma from Melanoma with Non-invasive Imaging

Excellent work by Markowitz, Bressler et al.! [13]. As a first, they describe complementary use of RCM and VivoSight OCT for in-vivo evaluation of melanoacanthoma. The notable absence of atypical vasculature, typical of melanoma on dynamic OCT, supported an in-vivo diagnosis of melanoacanthoma with higher confidence.

Video: OCT for Skin Cancer in Australia - Interview with Dr. Pascale Guitera

Dr. Pascale Guitera from the Melanoma Insitute of Australia elaborates on practical utility of VivoSight in an environment characterized by high skin cancer rates.

According to Dr. Guitera, VivoSight is especially appropriate for identifying and triaging BCC lesions followed by margin mapping for suitable treatment. Further on, OCT is employed during the follow-up process to monitor for clearance or eventual recurrances.

Play Video

Microneedle Array Patches for Contraception and HIV Prevention

New article by Paredes et al. on an important topic [14]. Microneedle Array Patches (MAPs) are a novel platform being developed for the delivery of hormonal contraception and antiretroviral drugs. MAPs provide enhanced drug delivery to the systemic circulation via the transdermal route when compared to transdermal patches, oral and injectable formulations.

VivoSight OCT is especially suited to analyze in-vivo the insertion behavior of microneedle patches, such as insertion depth, swelling and dissolution. VivoSight can also quantify and monitor changes to the vasculature and skin surface providing objetive data to help navigate the clinical and regulatory pathways. Note several educational blogs by Prof. Ryan Donnelly and VivoSight’s CEO Jon Holmes on our blog – click here 

VivoSight OCT is an excellent modality to aid in the identification of a large number of suspicious lesions, as encountered in conditions like Gorlin Syndrome or Nevoid Basal-Cell Carcinoma Syndrome. The sheer number of lesions makes it impractical to biopsy, but OCT non-invasive assessment and monitoring is an alternative option for disease management

PharmaTher Inc., a specialty life sciences company, has entered into an Exclusive Worldwide Patent and Know-how License Agreement with The Queen’s University of Belfast for the development and commercialization of a patented hydrogel-forming microneedle delivery technology developed by Professor Ryan Donnelly to support PharmaTher’s product and clinical development initiatives with ketamine. [Click here for PharmaTher Press Release] VivoSight OCT is heavily utilized by Prof. Ryan Donnelly and his group to optimize Microneedle Array Patch (MAP) performance. See a number of educational blogs here

Ryan Donnelly, PhD
Ryan Donnelly, PhD

A Simulive Virtual Interactive Event May 21 – 23, 2021

Participate in an exciting 3-day continuing medical education (CME) activity about value, complementary functions and limitations of noninvasive cutaneous imaging devices (including dermoscopy, reflectance confocal microscopy (RCM) and optical coherence tomography (OCT)) in various clinical settings.

Congress Co-Presidents: Orit Markowitz, MD and Melissa Gill, MD

Register here: RCM World Congress

Integrating Dermatoscope Images onto VivoSight Screen:

For a more comprehensive patient assessment, VivoSight makes it easy to integrate DermoGenius dermatoscopes from DermoScan GmbH, Germany.

Like the VivoSight handpiece, the dermatoscope can be inserted into the right or left holster of the VivoSight console. Dermatoscope images are then viewable on the VivoSight screen.

For a comprehensive overview of the high-quality DermoScan product line, please visit: https://dermoscan.de/en/

Dermatologist Dr. Bernd Algermissen manages a busy practice on Berlin’s famed Kurfuerstendamm: Avantgarde Lasermedizin. For many years, his VivoSight OCT system is firmly part of practice operations:

“For us, utilizing VivoSight means practicing precision medicine! It provides us with confirmation and confidence for a truly customized patient experience. Take for example the very prevalent condition of AK (Actinic Keratosis), which manifests itself in many different ways. Yes, we all debulk the thick lesion parts first with curettage, medical sandpaper, laser etc.. But how deep really is the pathology of a single lesion or in various areas? Only OCT can tell me lesion involvement for which I adjust the local or field treatment accordingly, rather than use a one size fits all approach.

During follow-up I check whether the pathology is gone, or if subclinical recurrences are beginning to appear over time, something I could never examine without OCT. Again, I can then propose a more subtle, customized therapy for long term, if not permanent, disease control.

For me and my patients, VivoSight plays an important role for personalized diagnosis, treatment selection, follow-up and monitoring if needed. The winner is the patient, getting a tailored approach with informed, efficient therapies.” 

Bernd Algermissen, MD
Bernd Algermissen, MD
Avantgarde-Lasermedizin Center in Berlin
Avantgarde-Lasermedizin Center in Berlin

References

1. Ortiz, A.E., Anderson, R.R. and Avram, M.M. (2015), 1064 nm long‐pulsed Nd:YAG laser treatment of basal cell carcinoma. Lasers Surg. Med., 47: 106-110. https://doi.org/10.1002/lsm.22310

2. Ortiz, A.E., Anderson, R.R., DiGiorgio, C., Jiang, S.I.B., Shafiq, F. and Avram, M.M. (2018), An expanded study of long‐pulsed 1064 nm Nd:YAG laser treatment of basal cell carcinoma. Lasers Surg. Med., 50: 727-731. https://doi.org/10.1002/lsm.22803

3. Ahluwalia, J., Avram, M.M. and Ortiz, A.E. (2019), Outcomes of long‐pulsed 1064 nm Nd:YAG laser treatment of basal cell carcinoma: A retrospective review. Lasers Surg. Med., 51: 34- 39. https://doi.org/10.1002/lsm.23041

4. Ahluwalia, Jusleen; Avram, Mathew M., Ortiz, Arisa E., The Evolving Story of Laser Therapeutics for Basal Cell Carcinoma, Dermatologic Surgery: August 2020 – Volume 46 – Issue 8 – p 1045- 1053, doi: 10.1097/DSS.0000000000002339

5. Markowitz O, Psomadakis CE. Patient-driven management using same-day noninvasive diagnosis and complete laser treatment of basal cell carcinomas: a pilot study. Cutis. 2019;104(6):345- E2.

6. Konstantin Moskalik, Alexander Kozlow, Eugeny Demin, Ernest Boiko . Powerful neodymium laser radiation for the treatment of facial carcinoma: 5 year follow-up data. European Journal of Dermatology. 2010;20(6):738-742. doi:10.1684/ejd.2010.1055

7. Chen CJ, Sierra H, Cordova M, Rajadhyaksha M. Confocal Microscopy–Guided Laser Ablation for Superficial and Early Nodular Basal Cell Carcinoma: A Promising Surgical Alternative for Superficial Skin Cancers. JAMA Dermatol. 2014;150(9):994–998. doi:10.1001/jamadermatol.2013.10225

8. Hibler, B., Sierra, H., Cordova, M., Phillips, W., Rajadhyaksha, M., Nehal, K. and Rossi, A. (2016), Carbon dioxide laser ablation of basal cell carcinoma with visual guidance by reflectance confocal microscopy: a proof‐of‐principle pilot study. Br J Dermatol, 174: 1359-1364. https://doi.org/10.1111/bjd.14414

9. Mehrabi, J.N., Kelly, K.M., Holmes, J.D. and Zachary, C.B. (2021), Assessing the Outcomes of Focused Heating of the Skin by a Long‐Pulsed 1064 nm Laser with an Integrated Scanner, Infrared Thermal Guidance, and Optical Coherence Tomography. Lasers Surg Med. https://doi.org/10.1002/lsm.23377

10. Stephens, R., Holmes, J. and Eadie, E. (2020), Lesion compression during light activation may improve efficacy of photodynamic treatment of basal cell carcinoma: preliminary results and rationale. J Eur Acad Dermatol Venereol, 34: e628-e630. https://doi.org/10.1111/jdv.16503

11. Wenande, E., Hendel, K., Mogensen, M., Bagger, C., Mårtensson, N.L., Persson, D.P., Lerche, C.M., Husted, S., Janfelt, C., Togsverd‐Bo, K., Anderson, R.R. and Haedersdal, M. (2021), Efficacy and Safety of Laser‐Assisted Combination Chemotherapy: An Explorative Imaging‐Guided Treatment With 5‐Fluorouracil and Cisplatin for Basal Cell Carcinoma. Lasers Surg Med, 53: 119-128. https://doi.org/10.1002/lsm.23323

12. Schuh S., Welzel J. (2020) OCT-Guided Laser Treatment and Surgery. In: Bard R. (eds) Image Guided Dermatologic Treatments. Springer, Cham. https://doi.org/10.1007/978-3-030-29236- 2_11

13. Bressler, Moshe; Felice, Skye; Yousefi, Nyousha; Marghoob, Nadeem; Alapati, Usha; Gill, Melissa; Markowitz, Orit; Combining Reflective Confocal Microscopy and Dynamic Optical Coherence Tomography to Diagnose Melanoacanthoma, The American Journal of Dermatopathology: February 16, 2021 – Volume Publish Ahead of Print – Issue – doi: 10.1097/DAD.0000000000001926

14. Alejandro J. Paredes, Inken K. Ramöller, Peter E. McKenna, Marco T.A. Abbate, Fabiana Volpe-Zanutto, Lalitkumar K. Vora, Maggie Kilbourne-Brook, Courtney Jarrahian, Kurtis Moffatt, Chunyang Zhang, Ismaiel A. Tekko, Ryan F. Donnelly, Microarray patches: Breaking down the barriers to contraceptive care and HIV prevention for women across the globe, Advanced Drug Delivery Reviews, Volume 173, 2021, Pages 331-348, ISSN 0169-409X, https://doi.org/10.1016/j.addr.2021.04.002.