Reflectance Confocal Microscopy in Basal Cell Carcinoma

NCT02623101 | Completed DMC

• 1 other identifier: RCM-onco ZonMw-1
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 3

Brief Summary

Skin cancer is the most common cancer and its incidence is increasing rapidly. The rising number of skin cancer may result in long waiting lists for consultation at departments for dermatological care and in increasing health care costs. In case of suspicion on skin cancer it is of utmost importance to diagnose and treat in an early phase, preferable in a patient friendly manner. Skin cancer comprises melanoma and non-melanoma skin cancer (NMSC: basal cell carcinoma (BCC), squamous cell carcinoma (SCC) and its precursors actinic keratosis (AK) and Bowen disease). As BCC is the most common skin cancer type with an estimated incidence of 51,000 new tumors in 2015 (The Netherlands), this study will focus on this skin cancer type. In case of suspicion on BCC, at present, the pathological examination of a biopsy is the gold standard for diagnosing a BCC. With the implementation of non invasive diagnosis by reflectance confocal microscopy (RCM) in routine patient care settings the diagnosis can be assessed at the first consultation in a non-invasive way and the patient can be treated instantly. Overall, the aim of this study is to investigate whether reflectance confocal microscopy can correctly identify the subtype of basal cell carcinoma. Study design: Randomized controlled trail. Comparison with usual care: punch biopsy and excision.

Conditions

Carcinoma, Basal Cell

Keywords

Reflectance confocal microscopy; Basal cell carcinoma; Biopsy; Diagnostics

Outcome Measures

Primary Outcomes (1)

• The number of correctly identified basal cell carcinoma and the subtype by Reflectance confocal microscopy validated by histopathological examination of the excision specimen

  Through study completion, an average of 3 years

Secondary Outcomes (3)

• Quality of life (Qol)

  Through study completion, an average of 3 years

• Cost effectiveness of Reflectance confocal microscopy as diagnostic tool to diagnose basal cell carcinoma

  Through study completion, an average of 3 years

• Quality Adjusted Live Years (QALY's)

  Through study completion, an average of 3 years

Study Arms (2)

Standard of care procedure

ACTIVE COMPARATOR

Clinical suspected basal cell carcinomas, of all subtypes, will be diagnosed by conventional 3mm punch biopsy of the most clinical suspicious part of the lesion. Punch biopsies will be performed under local anesthetics using 1% xylocaine/adrenaline. Hematoxylin/eosin stained sections of the punch biopsies will be evaluated by an experienced pathologist. Subjects will receive surgical excision according to subtype. When there is any doubt by reflectance confocal microscopic diagnosis, a punch biopsy will also be obtained and the lesion will be excized when the biopsy reveals a basal cell carcinoma.

Procedure: Punch biopsy; Procedure: Surgical excision

Reflectance confocal microscopy (RCM)

EXPERIMENTAL

The Vivascope 1500 and Vivascope 3000 (handheld divice) will be used (CE certified, Lucid Technologies, Henrietta, NY, USA). Reflectance confocal microscopy (RCM) imaging will be performed on clinical suspected basal cell carcinomas, of all subtypes. When there are signs of a basal cell carcinoma imaged by RCM, subjects will receive surgical excision according to subtype. When there is any doubt by RCM diagnosis, a punch biopsy will also be obtained and the lesion will be excized when the biopsy reveals a basal cell carcinoma.

Device: Reflectance confocal microscopy; Procedure: Surgical excision

Interventions

Reflectance confocal microscopy DEVICE

Non-invasive imaging of the lesion

Also known as: Confocal microscopy, Vivascope 1500, Vivascope 3000

Reflectance confocal microscopy (RCM)

Punch biopsy PROCEDURE

Obtaining a skin sample of the suspicious lesion under local anesthetics

Also known as: Biopsy

Standard of care procedure

Surgical excision PROCEDURE

Excision of the basal cell carcinoma lesion under local anesthetics

Also known as: Surgical removal, Surgery

Reflectance confocal microscopy (RCM); Standard of care procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be able to adhere to all requirements of the study
• Patients must be willing to give written informed consent
• Clinically diagnosed/ clinical suspicion of basal cell carcinoma

You may not qualify if:

• Participating in other investigational research currently or in the previous 28 days before the study
• Patient is having a medical condition which excludes participating the research, according to the investigator
• Incapacitated subjects will not be included
• Lesion(s) on parts of the body which do not allow to adequately image the tumour with RCM.

Sponsors & Collaborators

• Radboud University Medical Center: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• Mavig GmbH: collaborator

Study Sites (3)

Canisius Wilhelmina Hospital

Nijmegen, Netherlands

Location

Radboud University Medical Center

Nijmegen, Netherlands

Location

Rijnstate Hospital

Velp, Netherlands

Location

Related Publications (10)

• Flohil SC, de Vries E, Neumann HA, Coebergh JW, Nijsten T. Incidence, prevalence and future trends of primary basal cell carcinoma in the Netherlands. Acta Derm Venereol. 2011 Jan;91(1):24-30. doi: 10.2340/00015555-1009.

  PMID: 21264452 BACKGROUND

• Flohil SC, van der Leest RJ, Dowlatshahi EA, Hofman A, de Vries E, Nijsten T. Prevalence of actinic keratosis and its risk factors in the general population: the Rotterdam Study. J Invest Dermatol. 2013 Aug;133(8):1971-8. doi: 10.1038/jid.2013.134. Epub 2013 Mar 19.

  PMID: 23510990 BACKGROUND

• Housman TS, Feldman SR, Williford PM, Fleischer AB Jr, Goldman ND, Acostamadiedo JM, Chen GJ. Skin cancer is among the most costly of all cancers to treat for the Medicare population. J Am Acad Dermatol. 2003 Mar;48(3):425-9. doi: 10.1067/mjd.2003.186.

  PMID: 12637924 BACKGROUND

• Wolberink EA, Pasch MC, Zeiler M, van Erp PE, Gerritsen MJ. High discordance between punch biopsy and excision in establishing basal cell carcinoma subtype: analysis of 500 cases. J Eur Acad Dermatol Venereol. 2013 Aug;27(8):985-9. doi: 10.1111/j.1468-3083.2012.04628.x. Epub 2012 Jul 3.

  PMID: 22759209 BACKGROUND

• Peppelman M, Wolberink EA, Blokx WA, van de Kerkhof PC, van Erp PE, Gerritsen MJ. In vivo diagnosis of basal cell carcinoma subtype by reflectance confocal microscopy. Dermatology. 2013;227(3):255-62. doi: 10.1159/000354762. Epub 2013 Oct 18.

  PMID: 24158236 BACKGROUND

• Peppelman M, Wolberink EA, Koopman RJ, van Erp PE, Gerritsen MJ. In vivo Reflectance Confocal Microscopy: A Useful Tool to Select the Location of a Punch Biopsy in a Large, Clinically Indistinctive Lesion. Case Rep Dermatol. 2013 Apr 25;5(1):129-32. doi: 10.1159/000351258. Print 2013 Jan.

  PMID: 23687492 BACKGROUND

• Peppelman M, Nguyen KP, Hoogedoorn L, van Erp PE, Gerritsen MJ. Reflectance confocal microscopy: non-invasive distinction between actinic keratosis and squamous cell carcinoma. J Eur Acad Dermatol Venereol. 2015 Jul;29(7):1302-9. doi: 10.1111/jdv.12806. Epub 2014 Oct 30.

  PMID: 25357235 BACKGROUND

• Hoogedoorn L, Peppelman M, Blokx WAM, van Erp PEJ, Gerritsen MP. Prospective differentiation of clinically difficult to distinguish nodular basal cell carcinomas and intradermal nevi by non-invasive Reflectance Confocal Microscopy: a case series study. J Eur Acad Dermatol Venereol. 2015 Feb;29(2):330-336. doi: 10.1111/jdv.12548. Epub 2014 May 20.

  PMID: 24841762 BACKGROUND

• Longo C, Lallas A, Kyrgidis A, Rabinovitz H, Moscarella E, Ciardo S, Zalaudek I, Oliviero M, Losi A, Gonzalez S, Guitera P, Piana S, Argenziano G, Pellacani G. Classifying distinct basal cell carcinoma subtype by means of dermatoscopy and reflectance confocal microscopy. J Am Acad Dermatol. 2014 Oct;71(4):716-724.e1. doi: 10.1016/j.jaad.2014.04.067. Epub 2014 Jun 11.

  PMID: 24928707 BACKGROUND

• Peppelman M, Nguyen KP, Alkemade HA, Maessen-Visch B, Hendriks JC, van Erp PE, Adang EM, Gerritsen MJ. Diagnosis of Basal Cell Carcinoma by Reflectance Confocal Microscopy: Study Design and Protocol of a Randomized Controlled Multicenter Trial. JMIR Res Protoc. 2016 Jun 30;5(2):e114. doi: 10.2196/resprot.5757.

  PMID: 27363577 DERIVED

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

Microscopy, Confocal; Biopsy; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Intervention Hierarchy (Ancestors)

Microscopy; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Specimen Handling; Diagnostic Techniques, Surgical

Study Officials

• M JP Gerritsen, MD, PhD

  Radboud University Medical Center, Department of Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2015
• First Posted: December 7, 2015
• Study Start: December 1, 2015
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: September 20, 2019

Record last verified: 2018-04

Locations

NL (3)