CClinicalTrials.gg
CompletedNCT03145506Updated Aug 16, 2018

Spectrally Guided Mohs Surgery

An observational study in Skin Cancer, sponsored by Seton Healthcare Family. Completed. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2018-08-16.

Sponsored by Seton Healthcare Family · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
24
Ages
18 Years to 99 Years
Sex
All
01

Study summary

Freshly excised or freshly frozen tissue for Raman analysis will be obtained from a dermatology practice affiliated with UMCB. In the course of the routine removal of benign or malignant tumors in the office, skin cancer surgeons routinely check frozen sections to ensure adequate margins are obtained. Consent will be obtained from patients to provide freshly excised or freshly frozen leftover tissue obtained during Mohs surgery to be discarded after histological diagnosis. Freshly excised tissue will be measured at the time of excision before processing, while the freshly frozen tissue samples will be stored in a freezer at the Mohs clinic and transferred to the UT- Austin campus for spectroscopic analysis.

Read the detailed description

The current standard-of-care in the identification of skin cancer is visual inspection followed by biopsy and histopathology of suspicious skin sites. Since a physician is required to perform this biopsy, there is often a delay in diagnosis, resulting in deeper, more aggressive tumors and increased mortality from malignant melanoma (MM). Therefore, a non-invasive method to inspect these lesions would be of great clinical importance.

An initial prototype of a noninvasive diagnostic device was developed based on optical spectroscopy and completed a clinical study in 76 patients that demonstrated high diagnostic accuracy for the detection of skin cancer (IRB # CR-10-004). This initial prototype consisted of two separate devices and probes: one to collect Raman spectra (RS) and the other to collect diffuse reflectance and laser induced fluorescence spectra (DRS+LIFS). type, but a combination of modalities gave the best diagnostic performance for all types of skin cancer.

The addition of Raman spectroscopy improved diagnostic performance for both melanoma and non-melanoma skin cancer. However, the operation of the integrated systems was still conducted via two optical fiber probes (the first one for fluorescence and reflectance spectroscopy, the second one for Raman spectroscopy). The need to take measurements of the same lesion using two probes increased acquisition time, and the possible sampling site error. Recently, a device was developed that combined fiber optic probe that is capable for spectral acquisition of Raman, white light reflectance and laser induced fluorescence spectroscopy. Using this probe, acquisition time and sampling site error should be reduced. There is no significant difference in terms of performance between the previous two probes and the new probe.

Models have been developed to analyze reflectance and fluorescence spectroscopy data. In order to interpret Raman spectroscopy data in physiologically relevant parameters, a biophysical model needs to be developed. Similar models have been developed by other research groups for other types of tissue.

This study proposes to use the new technique of biophysical modeling to analyze our Raman spectra. At the core of the technique is the measurement of a set of "basis spectra" which are fit to the data using ordinary least-squares. Recently, biophysical models have been developed for atherosclerosis and breast cancer with very impressive diagnostic results, achieving 94% sensitivity and 96% specificity for breast cancer and 94% accuracy for atherosclerosis disease classification.

Raman microspectrometry will be used to measure basis spectra from various skin constituents. In this technique, Raman spectra are measured from freshly frozen tissue samples that are sliced into thin sections as is done in histology. A microscope system is used to focus the excitation laser beam to a small spot of approximately 2 mm in diameter on the sample, and a Raman spectrometer measures the emitted Raman spectrum. In this way, Raman spectra of individual microscopic tissue components can be isolated. These individual component spectra will be determined for keratin, cell nuclei, collagen, cytoplasm, melanin, water, sebaceous glands, etc.

02

Conditions studied

  • Skin Cancer

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03

In context

Skin Neoplasms

582 studies on the registry are indexed under Skin Neoplasms; 114 are open to participants now.

This study's enrollment of 24 is below the median of 200 across 134 observational studies indexed under Skin Neoplasms.

Browse Skin Neoplasms studies →

Lead sponsor

Seton Healthcare Family is the lead sponsor of 21 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients undergoing treatment for SCC or BCC in local Mohs surgery clinic

Inclusion criteria

  • All individuals over 18 undergoing Mohs surgery for treatment of BCC or SCC

Exclusion criteria

Exclusion Criteria:

  • Under 18 years old, not undergoing Mohs surgery for treatment of BCC or SCC
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
24 participants (actual)
Patient registry
No

Groups and cohorts

  • Mohs Surgery Patients

    Adult patients undergoing Mohs surgery for treatment of BCC or SCC

    Device: Multimodal Spectroscopy

Interventions

  • DeviceMultimodal Spectroscopy

    optical measurement of excised tissue

06

What researchers measure

Primary outcomes

  1. Sensitivity and specificity of spectroscopic device

    comparison of spectroscopic data to frozen section pathology used in Mohs surgery

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 16, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03145506
Lead sponsor
Seton Healthcare Family
Collaborators
University of Texas at Austin
Responsible party
Sponsor
First posted
May 9, 2017
Start date
Nov 2016
Primary completion
Dec 2016
Completion
Jul 2018
Last update
Aug 16, 2018

Study contacts

Jason Reichenberg, MD
principal investigator · Seton Healthcare Family

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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