Spectral Diagnosis of Cutaneous Malignancy - Full Text View

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: Cancer 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. ] [ Designated as safety issue: No ]


Estimated Enrollment:	350
Study Start Date:	April 2007
Estimated Primary Completion Date:	April 2018 (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

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


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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:

Male or Female and over 18 years of age.
Patients undergoing an examination of their skin
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
Patients whose lesion also warrants a biopsy.
Signed informed consent document.

Exclusion Criteria:

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

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	May 18, 2007
Last Updated:	May 25, 2016
Health Authority:	United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 30, 2016