NCT02750033

Brief Summary

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2016

Shorter than P25 for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 25, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

August 20, 2018

Status Verified

August 1, 2018

Enrollment Period

2 months

First QC Date

April 20, 2016

Last Update Submit

August 17, 2018

Conditions

Squamous Cell Carcinoma (SCC)Basal Cell Carcinoma (BCC)

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and specificity of MMS compared to histopathology during Mohs surgery

    May, 2016 to December, 2016 up to 6 moths

Study Arms (2)

Basal Cell Carcinoma (BCC)

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.

Device: Multimodal Spectroscopy (MMS)

Squamous Cell Carcinoma (SCC)

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.

Device: Multimodal Spectroscopy (MMS)

Interventions

Multimodal Spectroscopy (MMS)DEVICE

surgical margin assessment with multimodal optical spectroscopy (MMS) device

Basal Cell Carcinoma (BCC)Squamous Cell Carcinoma (SCC)

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients undergoing Mohs surgery to remove basal or squamous cell carcinoma.

You may qualify if:

  • Male or Female and over 18 years of age.
  • Patients undergoing Mohs surgery for SCC or BCC

You may not qualify if:

  • Male or Female and under 18 years of age.
  • Patients with diagnosis other than SCC or BCC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Robinson 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: 16193624BACKGROUND

  • Asgari 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: 22117877BACKGROUND

  • Koslosky 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: 25099294BACKGROUND

  • Sharma 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: 25173240BACKGROUND

  • Lim 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: 25375350BACKGROUND

MeSH Terms

Conditions

Carcinoma, Squamous CellCarcinoma, Basal Cell

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous CellNeoplasms, Basal Cell

Study Officials

  • Jason Reichenberg, MD

    Seton Healthcare Family

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 20, 2016

First Posted

April 25, 2016

Study Start

October 1, 2016

Primary Completion

December 1, 2016

Study Completion

March 1, 2017

Last Updated

August 20, 2018

Record last verified: 2018-08