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Spectral Diagnosis of Cutaneous Malignancy

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00476905
First Posted: May 22, 2007
Last Update Posted: June 1, 2017
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.
Collaborator:
University of Texas at Austin
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose
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.

Condition Intervention
Skin Cancer Device: Spectral Diagnosis Probe

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Spectral Diagnosis of Cutaneous Malignancy

Resource links provided by NLM:

MedlinePlus related topics: Skin Cancer
U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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. ]
Estimated Enrollment: 350
Actual Study Start Date: April 2007
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Optical Spectroscopy

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.

  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.
  Contacts and Locations
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): NCT00476905


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
University of Texas at Austin
Investigators
Principal Investigator: Michael Migden, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
University of Texas MD Anderson Cancer Center Website  This link exits the ClinicalTrials.gov site

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00476905     History of Changes
Other Study ID Numbers: 2006-0856
First Submitted: May 18, 2007
First Posted: May 22, 2007
Last Update Posted: June 1, 2017
Last Verified: May 2017

Keywords provided by M.D. Anderson Cancer Center:
Basal Cell Carcinoma
Squamous Cell Carcinoma
Pre-Cancer Lesions
Pigmented Lesions
 Benign Lesions
Skin Cancer
Spectral Diagnosis
Optical Spectroscopy

Additional relevant MeSH terms:
Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases


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