Spectral Diagnosis of Cutaneous Malignancy

May 17, 2019 updated by: M.D. Anderson Cancer Center
The goal of this clinical research study is to evaluate the use of an imaging technology called spectral diagnosis. Researchers want to find out if a special spectral-diagnosis probe can be used to detect skin cancers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The spectral-diagnosis probe being used in this study uses dim pulses of light to identify features of tissue that may be related to the status of skin cancer. The probe is shaped like a catheter, and it has a camera on the end, which takes pictures of the skin.

If you agree to take part in this study, you will be asked questions about your age, race, smoking status, and the status of any diseases you may have (such as diabetes, connective tissue disease, and infectious disease). It should take about 5 minutes to answer these questions.

The study doctor will then decide which of your lesions are suitable for imaging by the probe. If necessary, any hair on or around the lesion(s) will be shaved or trimmed. The area(s) of skin being imaged will be cleaned with rubbing alcohol.

As part of your exam, the study doctor will use the probe to measure the selected areas of tissue. To perform the spectral-diagnosis measurement, the probe will be gently placed on the surface of your skin. Each selected area of your skin will take about a few seconds to image. The probe will shine different types of light onto the skin, and it will collect the light that reflects from the skin surface. The light signals will be stored so that researchers can look at them. Preparing the lesion, imaging it, and collecting the light signals should take about 10-15 minutes per lesion.

After all of the imaging is over, you will have biopsies performed on the lesions that your study doctor has decided are in need of such treatment as part of your standard care.

After this clinic visit, your participation in the study will be over.

This is an investigational study. The imaging probe is not commercially available or FDA approved. At this time, it is being used in research only. Up to 150 patients will take part in this study. All will be enrolled at M. D. Anderson.

Study Type

Observational

Enrollment (Anticipated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patients, at routine skin examination, found to have a lesion(s) in one of the five categories: basal cell carcinoma, squamous cell carcinoma, pre-cancer lesions, pigmented lesions, and benign lesions, which may also warrant biopsy.

Description

Inclusion Criteria:

  1. Male or Female and over 18 years of age.
  2. Patients undergoing an examination of their skin
  3. Patients with a lesion(s) in one of the five categories: basal cell carcinoma, squamous cell carcinoma, pre-cancer lesions, pigmented lesions, and benign lesions
  4. Patients whose lesion also warrants a biopsy.
  5. Signed informed consent document.

Exclusion Criteria:

  1. Patients with absence of skin lesion(s) in one of the five categories.
  2. Patients whose identified lesion did not need a biopsy.
  3. Patients who did not sign the informed consent and agree to participate.

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Spectral-Diagnosis
Method for noninvasive detection of cutaneous malignancies
Device: Spectral Diagnosis Probe
The device collects two types of tissue spectra: i) laser-induced fluorescence spectra and ii) white light reflectance spectra. This portable reflectance spectrofluorimeter collects spectra in a fraction of a second. Light collection and delivery are achieved via an optical fiber probe. The optical fiber probe is approximately 1 mm in diameter and 3 m long. The same probe collects light emitted from the tissue and delivers it back to the instrument for spectral analysis.
Other Names:
  • Optical Spectroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Spectroscopic features of skin lesions in vivo
Time Frame: Preparing lesion, imaging it, and collecting the light signals should take about 10-15 minutes per lesion.
Preparing lesion, imaging it, and collecting the light signals should take about 10-15 minutes per lesion.

Collaborators and Investigators

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

Sponsor

M.D. Anderson Cancer Center

Collaborators

University of Texas at Austin

Investigators

  • Principal Investigator: Michael Migden, MD, M.D. Anderson Cancer Center

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.

Helpful Links

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)

April 1, 2007

Primary Completion (Actual)

November 20, 2018

Study Completion (Actual)

November 20, 2018

Study Registration Dates

First Submitted

May 18, 2007

First Submitted That Met QC Criteria

May 21, 2007

First Posted (Estimate)

May 22, 2007

Study Record Updates

Last Update Posted (Actual)

May 20, 2019

Last Update Submitted That Met QC Criteria

May 17, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-0856

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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