Clinical trial · Observational
Intraoperative Margin Assessment During Mohs Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Protocol changed to meet IRB requirements for patient safety
Summary
Brief summary (as posted)
The research team will develop an intraoperative handheld device for assessing surgical margins during Mohs surgery. The device technology is based on multimodal optical spectroscopy (MMS), combining three optical spectroscopy techniques into one device. The researchers will first acquire proof of concept MMS measurements within the Mohs surgery suite immediately after surgical excision and prior to histological processing. MMS measurements will be acquired directly on the patient from the NMSC excision site. The final outcome of this study will result in the sensitivity and specificity of MMS compared to histopathology during Mohs surgery. These results will allow for the estimation of the potential benefit of an intraoperative margin assessment technique.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Basal Cell Carcinoma (BCC) | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.85 |
| Squamous Cell Carcinoma (SCC) | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multimodal Spectroscopy (MMS) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Basal Cell Carcinoma (BCC)
- description
- Adult patients undergoing Mohs surgery to remove basal cell carcinoma (BCC) will have surgical margins assessed with multimodal optical spectroscopy (MMS) device, as well as standard histopathology evaluation.
- interventionNames
- Device: Multimodal Spectroscopy (MMS)
- label
- Squamous Cell Carcinoma (SCC)
- description
- Adult patients undergoing Mohs surgery to remove squamous cell carcinoma (BCC) will have surgical margins assessed with multimodal optical spectroscopy (MMS) device, as well as standard histopathology evaluation.
- interventionNames
- Device: Multimodal Spectroscopy (MMS)
Primary outcomes (1)
- measure
- Sensitivity and specificity of MMS compared to histopathology during Mohs surgery
- timeFrame
- May, 2016 to December, 2016 up to 6 moths
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or Female and over 18 years of age. 2. Patients undergoing Mohs surgery for SCC or BCC Exclusion Criteria: 1. Male or Female and under 18 years of age. 2. Patients with diagnosis other than SCC or BCC
References
Publications (5)
- BACKGROUNDRobinson JK. Sun exposure, sun protection, and vitamin D. JAMA. 2005 Sep 28;294(12):1541-3. doi: 10.1001/jama.294.12.1541. No abstract available. PMID 16193624
- BACKGROUNDAsgari MM, Olson JM, Alam M. Needs assessment for Mohs micrographic surgery. Dermatol Clin. 2012 Jan;30(1):167-75, x. doi: 10.1016/j.det.2011.08.010. PMID 22117877
- BACKGROUNDKoslosky CL, El Tal AK, Workman B, Tamim H, Durance MC, Mehregan DA. Reliability of skin biopsies in determining accurate tumor margins: a retrospective study after Mohs micrographic surgery. Dermatol Surg. 2014 Sep;40(9):964-70. doi: 10.1097/01.DSS.0000452621.79017.19. PMID 25099294
- BACKGROUNDSharma M, Marple E, Reichenberg J, Tunnell JW. Design and characterization of a novel multimodal fiber-optic probe and spectroscopy system for skin cancer applications. Rev Sci Instrum. 2014 Aug;85(8):083101. doi: 10.1063/1.4890199. PMID 25173240
- BACKGROUNDLim L, Nichols B, Migden MR, Rajaram N, Reichenberg JS, Markey MK, Ross MI, Tunnell JW. Clinical study of noninvasive in vivo melanoma and nonmelanoma skin cancers using multimodal spectral diagnosis. J Biomed Opt. 2014;19(11):117003. doi: 10.1117/1.JBO.19.11.117003. PMID 25375350