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Special Edition Q3, 2022

66% of Diagnostic Biopsies for Common Skin Cancer can be Avoided Using Michelson Diagnostics’ VivoSight OCT Laser Scanner

Major Netherlands study shows that VivoSight OCT is non-inferior to and more cost-effective than punch biopsy

A major study published in leading cancer journal The Lancet Oncology [1] has shown in a large, multi-centre, head-to-head randomised clinical trial, that use of Michelson Diagnostics’ VivoSight OCT laser scanner to diagnose the common skin cancer type Basal Cell Carcinoma is as safe and effective as biopsy, and so could avoid diagnostic skin biopsy procedures in as many as 66% of cases, also saving time and money for the health service.

This new publication in The Lancet Oncology reports results from the study performed in the Netherlands at three dermatology centres by a research group led by Professor Klara Mosterd at University of Maastricht. 598 Patients were randomly split into two groups, one group being diagnosed using VivoSight OCT scan and other group with punch biopsy. Treatment decisions were made on the basis of diagnosis of BCC and BCC subtype, and then 12 months after treatment the two groups were compared in terms of the rate of disease recurrence and the costs.

The results were clear: the proportion of patients in the OCT arm with recurrent disease was slightly less than in the biopsy group (6% vs 7%) and furthermore, the overall costs of diagnosis and treatment using OCT was found to be €69 less per lesion than by using biopsy.

The authors concluded “this trial shows that OCT-guided diagnosis and treatment is safe and non-inferior to regular care. In 66% of patients, a biopsy could be avoided, thus minimising treatment delay and avoiding an invasive procedure”

1. 12 months after treatment, 94% of lesions diagnosed with BCC by OCT were free of recurrent or residual lesions, compared to 93% of lesions with punch biopsy;

2. Of the patients who still had recurrent or residual lesions at 12 months, only 9 in the OCT group had malignant recurrent lesions, versus 15 in the biopsy group (the remainder had premalignant lesions);

3. OCT was determined to be ‘non-inferior’ to punch biopsy using a pre-defined non-inferiority margin of -10%. 4. 66% of diagnostic biopsies could be avoided by the use of OCT;

5. The cost of using the OCT for diagnosis and treatment was significantly lower than with punch biopsy. Considering diagnosis alone, OCT cost €233, vs. €308 for biopsy, and then for diagnosis and treatment OCT cost €689 vs €758 for biopsy.

1. Study took place at 3 Netherlands institutions.

2. Eligible participants were adults > 18 years with indication for biopsy of a lesion with basal cell carcinoma in the differential diagnosis

and where doubt remained as to whether lesions is benign, premalignant, malignant, and BCC subtype

3. Excluded were lesions in high-risk H-zone of face, or locally advanced BCC

4. 598 patients were recruited and randomized into 2 arms. One arm received standard of care with diagnostic punch biopsy.

5. Lesions in the other arm were scanned with VivoSight OCT. The observer attempted to identify whether the lesion was BCC and if so what subtype.

6. Any lesion not highly confidently identified as BCC or subtype unclear, was returned to standard of care via punch biopsy. (this resulted to be 33% of lesions)

7. Lesions highly confidently ruled in as BCC and with BCC subtype were considered for non-invasive or surgical treatment according to the subtype and patient preference, and this treatment was scheduled. (this was 66% of lesions)

8. For safety, a punch biopsy was additionally taken of these lesions and checked for potential intervention if the OCT result would compromise patient safety.

9. At 12 months after treatment, a dermatologist blinded to the study arm performed follow-up to identify any possible recurrence or residual lesion; any suspected recurrence or residual lesion was biopsied.

Michelson Diagnostics’ CEO Jon Holmes comments:

This large, thorough, well designed and implemented study clearly demonstrates the potential value of VivoSight OCT in the clinical pathway for low-risk BCC. Previous studies by groups in Germany (Ulrich et al.), USA (Markowitz et al.) and Australia (Cheng et al.) provided solid evidence of the high diagnostic accuracy of OCT, confirming that it is more accurate than clinical or dermoscopic examination alone, and suggested that a proportion of diagnostic biopsies could be avoided.

Prof. Mosterd’s group has achieved the next step, of showing that if OCT is indeed used to rule-in BCC and to identify the BCC subtype, in order to select treatment without biopsy, then the final patient outcome in terms of lesion clearance is non-inferior to using biopsy instead; and furthermore, they found that the OCT pathway is more cost-effective and involves fewer patient consultation visits.

Professor Mosterd’s group has already published several other papers deriving from this work, including a study of value of image markers for BCC [1], patient preference for OCT vs biopsy [2] and of the learning curve for OCT users [3]. All highly recommended reading!

Given the increased publications on VivoSight OCT imaging features for BCC (see Latest News), we’d like to remind on the availability of the course “OCT in Practice” (see also in our July 2021 Newsletter).

The modular course is aimed at VivoSight newcomers and experienced users alike. Presently, 12 main topics are being covered (overview >> here) focusing on when and how to ideally use OCT. You will learn how to assess the most common skin tumors and pathology based on typical visual criteria and receive helpful tips and explanations on OCT image interpretation (Figs. 1a, b). We also present rare or experimental OCT applications. Finally, test your knowledge in a quiz on OCT images of BCCs!

1. lrich, M., von Braunmuehl, T., Kurzen, H., Dirschka, T., Kellner, C., Sattler, E., Berking, C., Welzel, J. and Reinhold, U. (2015), The sensitivity and specificity of optical coherence tomography for the assisted diagnosis of nonpigmented basal cell carcinoma: an observational study. Br J Dermatol, 173: 428-435. https://doi.org/10.1111/bjd.13853.

OCT significantly improved the diagnostic specificity for BCC compared with clinical assessment and dermoscopy alone.

The accuracy of diagnosis for all lesions increased from 65.8 % with clinical evaluation to 76.2 % following additional dermoscopy and to 87.4 % with the addition of OCT.

2. Markowitz O, Schwartz M, Feldman E, Bienenfeld A, Bieber AK, Ellis J, Alapati U, Lebwohl M, Siegel DM. Evaluation of Optical Coherence Tomography as a Means of Identifying Earlier Stage Basal Cell Carcinomas while Reducing the Use of Diagnostic Biopsy. J Clin Aesthet Dermatol. 2015 Oct;8(10):14-20

OCT significantly (p < 0.01) improved sensitivity and specificity over clinical or dermoscopic evaluation. It increased the certainty of diagnosis; clinicians indicated they were certain in 17 percent of lesions examined clinically, in 38.6 percent examined with dermoscopy, and in 70 percent examined with optical coherence tomography.

With the use of Optical Coherence Tomography in the diagnosis of basal cell carcinoma, more than 1 in 3 patients could avoid a diagnostic biopsy.

3. Cheng, H. and Guitera, P. (2015), Systematic review of optical coherence tomography usage in the diagnosis and management of basal cell carcinoma. Br J Dermatol, 173: 1371-1380. https://doi.org/10.1111/bjd.14042

This systematic review provides an overview of the clinical applications of OCT in the diagnosis and management of BCC. OCT has been suggested to be useful in the diagnosis, treatment planning and treatment monitoring of BCC.

VivoSight OCT is used in many other research areas besides skin cancer & BCC

To spread the utility of VivoSight OCT across more research areas, please see our website and visit our Applications, Publications, Newsletter and Blog webpages. Research applications include:

  • Autoimmune and Inflammatory Diseases
  • Aesthetic Medicine, Vascular Lesions and Scars • Wounds & Burns
  • Nails & Onychomycosis
  • Melanomas and Pigmented Lesions
  • Alopecia and Hair Disorders
  • Other Dermatology Applications

VivoSight has been involved in over 380 publications. Download the publications list from our website here:

https://us.vivosight.com/publications-replacement/

Successful Meeting at ASLMS 2022 for Michelson Diagnostics Ltd. (MDL)

MDL received great attention at the recent annual meeting of the American Society of Lasers in Medicine and Surgery (ASLMS) in San Diego.

VivoSight OCT was well covered during the plenary session by Kristen Kelly, MD highlighting its value for imaging and quantifying vascular lesions in research for new treatments.

In addition, several presentations on VivoSight OCT applications were given by accomplished clinicians and researchers, and shown in this partial list:

Jordan V. Wang, MD, MBE, MBA
CLINICAL AND OCT EVALUATION OF VASCULAR LESIONS TREATED WITH A NOVEL VARIABLE-SEQUENCED LONG-PULSED 532NM LASER

Vascular lesions and conditions often require treatment with lasers that selectively target hemoglobin. More recently, a novel variable-sequenced long-pulsed 532 nm laser was developed, which incorporates variable sequential pulsing with 0.3 ms or 1.5 ms pulses, large spot sizes, and cryogen spray cooling. Dynamic optical coherence tomography (OCT) imaging has also been used to measure vascular characteristics. Here, we use OCT to evaluate treatment outcomes of vascular lesions from this novel laser.

Christopher B. Zachary, MBBS, FRCP
ANALYSIS BY OCT OF PRE/POST Long Pulse 1064 NM LASER TREATMENT OF SUPERFICIAL AND NODULAR BCCs

Treatment of superficial and nodular BCCs by the long pulsed 1064nm laser is used in both Europe and the USA. Imaging by optical coherence tomography (OCT) might objectively improve outcomes following this treatment modality. This two center, IRB approved prospective study examined the quality and usefulness of mapping tumor margins prior to and three months after treatment.

John Wuennenberg, MD
USE OF OPTICAL COHERENCE TOMOGRAPHY AND REFLECTANCE CONFOCAL MICROSCOPY TO GUIDE TREATMENT MARGINS OF BASAL CELL CARCINOMA

Determining the clinical margins of Basal Cell Carcinoma (BCC) is challenging. Noninvasive in vivo images of the skin created by Optical Coherence Tomography (OCT) and Reflectance Confocal Microscopy (RCM) can aid in this endeavor. Interpreting OCT is challenging for the novice user which may result in benign lesions being interpreted as superficial BCC. The use of RCM with higher, near histologic, resolution relative to OCT can help detect the presence of BCC. Since RCM imaging is more time consuming for larger lesions relative to OCT, its utilization as a targeted approach in combination with OCT can be more efficient.

OCT-Guided Laser Treatment of Basal Cell Carcinoma: One Year Follow-Up

Prof. Uwe Reinhold gave an excellent talk on the above topic at the esteemed Derma 2022 annual meeting in Frankenthal, Germany https://www.kongress-derm.de

Topic and results will soon be published in the journal of the J EADV. As conclusion it can be summarized that OCT-controlled 1064 nm Nd:YAG laser treatment of superficial BCC provide for:

  • High detection rate due to use of OCT
  • High remission rate
  • Short treatment time
  • Potential of treatment of multiple lesions in one session • Good cosmetic outcomes

Elevator Chat with Klara Mosterd, MD – Maastricht, Netherlands

Klara Mosterd is a Professor of Oncodermatology, Mohs Surgeon and Dermatologist at Maastricht University Medical Center

“As we are a center of excellence in the field of skin cancer, we see many patients and are always striving to find ways to improve their care. Few years ago we developed a vision to improve patient care and operational efficiency for BCC using OCT, which we saw had great potential. There had already been some great work published by other groups, but we saw some gaps in the research that needed addressing, and so we set to work!

We have already published several papers towards this goal, and our work now culminates in the just issued Lancet Oncology article. We are very happy with the published results and believe that OCT, using Michelson’s VivoSight OCT scanner, will make a huge difference to patients, saving many of them from invasive biopsies and extra hospital visits, and also saving hospitals money and reducing delays in the BCC clinical pathway.

We know that there is much more to come from VivoSight OCT and are excited to hear that Michelson is already working on Artificial Intelligence algorithms to further aid clinicians in our fight against BCC!

References

1. Adan F, Nelemans PJ, Essers BA, Brinkhuizen T, Dodemont SR, Kessels JP, Quaedvlieg PJ, Dermont GJ, Winnepenninckx VJ, Hamid MA, Kelleners-Smeets NW. Optical coherence tomography versus punch biopsy for diagnosis of basal cell carcinoma: a multicentre, randomised, non-inferiority trial. The Lancet Oncology. 2022 Jul 11.
2. Adan F, Mosterd K, Kelleners-Smeets NW, Nelemans PJ. Diagnostic Value of Optical Coherence Tomography Image Features for Diagnosis of Basal Cell Carcinoma. Acta dermato-venereologica. 2021 Nov 1.
3. Adan F, Mosterd K, Wolswijk T, Kelleners-Smeets NW, Essers BA. Patient Preference for Optical Coherence Tomography versus Punch Biopsy for Diagnosis of Basal Cell Carcinoma: A Labelled Discrete Choice Experiment. Acta Dermato-Venereologica. 2021 Dec 14.
4. Loo E, Sinx K, Welzel J, Schuh S, Kelleners-Smeets N, Mosterd K, Nelemans P. Cumulative sum analysis for the learning curve of optical coherence tomography assisted diagnosis of basal cell carcinoma.
5. Ulrich, M., von Braunmuehl, T., Kurzen, H., Dirschka, T., Kellner, C., Sattler, E., Berking, C., Welzel, J. and Reinhold, U. (2015), The sensitivity and specificity of optical coherence tomography for the assisted diagnosis of nonpigmented basal cell carcinoma: an observational study. Br J Dermatol, 173: 428-435. https://doi.org/10.1111/bjd.13853.
6. Markowitz O, Schwartz M, Feldman E, Bienenfeld A, Bieber AK, Ellis J, Alapati U, Lebwohl M, Siegel DM. Evaluation of Optical Coherence Tomography as a Means of Identifying Earlier Stage Basal Cell Carcinomas while Reducing the Use of Diagnostic Biopsy. J Clin Aesthet Dermatol. 2015 Oct;8(10):14-20.
7. Cheng, H. and Guitera, P. (2015), Systematic review of optical coherence tomography usage in the diagnosis and management of basal cell carcinoma. Br J Dermatol, 173: 1371-1380. https://doi.org/10.1111/bjd.14042