Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intraoperative Margin Assessment During Mohs Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02750033
Recruitment Status : Withdrawn (Protocol changed to meet IRB requirements for patient safety)
First Posted : April 25, 2016
Last Update Posted : August 20, 2018
Sponsor:
Collaborators:
University of Texas at Austin
Dell Medical School at The University of Texas at Austin
Information provided by (Responsible Party):
Jason Reichenberg, Seton Healthcare Family

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.

Condition or disease Intervention/treatment
Squamous Cell Carcinoma (SCC) Basal Cell Carcinoma (BCC) Device: Multimodal Spectroscopy (MMS)

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.


Layout table for study information
Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Intraoperative Margin Assessment During Mohs Surgery
Actual Study Start Date : October 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : March 2017

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




Primary Outcome Measures :
  1. Sensitivity and specificity of MMS compared to histopathology during Mohs surgery [ Time Frame: May, 2016 to December, 2016 up to 6 moths ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients undergoing Mohs surgery to remove basal or squamous cell carcinoma.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02750033


Sponsors and Collaborators
Seton Healthcare Family
University of Texas at Austin
Dell Medical School at The University of Texas at Austin
Investigators
Layout table for investigator information
Principal Investigator: Jason Reichenberg, MD Seton Healthcare Family

Publications:
Layout table for additonal information
Responsible Party: Jason Reichenberg, MD, Seton Healthcare Family
ClinicalTrials.gov Identifier: NCT02750033     History of Changes
Other Study ID Numbers: CR-16-049
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Squamous Cell
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms, Basal Cell