Intraoperative Margin Assessment During Mohs Surgery

August 17, 2018 updated by: Jason Reichenberg, Seton Healthcare Family
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Acquire intraoperative MMS measurements in vivo. After assessing this approach on excised tissues, MMS measurements will be aquired directly on the patient from the NMSC excision site. MMS data will be acquired on patients being treated for NMSC at the Austin Dermatologic Surgery Center, the surgical site for the dermatology practice of Seton/University of Texas Physicians group. Similar to the measurements on freshly excised tissues, MMS data will be acquired in a grid pattern on the excision site. The site will be blotted with gauze to remove residual blood prior to the measurement, and continuously blotted as needed until all measurements have been taken. The handheld probe of the MMS enables assessment of both the wound periphery and deeper layers of tissue to determine if any tumor is remaining. For this initial pilot study, we plan to take measurements on 10 patients (5 BCC, 5 SCC), along with corresponding normal tissue measurements.

Retrospective analysis of MMS sensitivity and specificity. The MMS technique is an information rich modality providing both morphological and functional parameters of the interrogated tissue that could be correlated to known tumor pathology. However, this extracted information will require development of sophisticated spectral analysis models which would be beyond the scope of the current study. Therefore, for the purpose of this study, standard statistical techniques will be used to determine the classification power of MMS for tumor margin detection. While this approach does not fully elucidate the underlying pathology responsible for the classification, these types of models have been shown to perform at or better than those based on a morphological approach. This approach has been previously employed to classify skin cancer with high diagnostic accuracy. 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. This type of retrospective study will provide a proof of concept that would warrant further development and prospective studies of the MMS approach.

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
surgical margin assessment with multimodal optical spectroscopy (MMS) device
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)
surgical margin assessment with multimodal optical spectroscopy (MMS) device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensitivity and specificity of MMS compared to histopathology during Mohs surgery
Time Frame: May, 2016 to December, 2016 up to 6 moths
May, 2016 to December, 2016 up to 6 moths

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seton Healthcare Family

Collaborators

University of Texas at Austin
Dell Medical School at The University of Texas at Austin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2016

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

March 1, 2017

Study Registration Dates

First Submitted

April 20, 2016

First Submitted That Met QC Criteria

April 20, 2016

First Posted (ESTIMATE)

April 25, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 20, 2018

Last Update Submitted That Met QC Criteria

August 17, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR-16-049

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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