Skin CancerNCT00476905
Spectral Diagnosis of Cutaneous Malignancy
An observational study of Skin Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Cancer
- What is being tested?
- Spectral Diagnosis Probe
- Type of treatment
- Medical device
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to 20 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
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.
Read the 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.
- Conditions
- Skin Cancer
- Being tested
- Spectral Diagnosis Probe
- Keywords
- Basal Cell Carcinoma, Squamous Cell Carcinoma, Pre-Cancer Lesions, Pigmented Lesions, Benign Lesions, Skin Cancer, Spectral Diagnosis, Optical Spectroscopy
- Medical subject headings
- Skin Neoplasms, Carcinoma, Basal Cell, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spectral Diagnosis ProbeDevice
Also called Optical Spectroscopy
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.
| Study group | Role | What they receive |
|---|---|---|
| Spectral-Diagnosis | Method for noninvasive detection of cutaneous malignancies Receives: Device: Spectral Diagnosis Probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spectroscopic features of skin lesions in vivo
Measured: Preparing lesion, imaging it, and collecting the light signals should take about 10-15 minutes per lesion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2007 (estimated)
- Study startApr 2007
- Primary completion20 Nov 2018
- Study completion20 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas at Austin
- Responsible party
- Sponsor
- Investigators
- Michael Migden, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00476905
- Sponsor's protocol ID
- 2006-0856
- Status last verified
- May 2019
- First submitted
- 18 May 2007
- Last updated
- 20 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spectral Diagnosis of Cutaneous Malignancy
- ClinicalTrials.gov ID
- NCT00476905
- Acronym / sponsor ID
- 2006-0856
- Conditions
- Skin Cancer
- Keywords
- Basal Cell Carcinoma, Squamous Cell Carcinoma, Pre-Cancer Lesions, Pigmented Lesions, Benign Lesions, Skin Cancer, Spectral Diagnosis, Optical Spectroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- University of Texas at Austin
- Study start
- Apr 2007 (actual)
- Primary completion
- 20 Nov 2018 (actual)
- Study completion
- 20 Nov 2018 (actual)
- First posted
- 22 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spectral-Diagnosis | – | Device: Spectral Diagnosis ProbeMethod for noninvasive detection of cutaneous malignancies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spectral Diagnosis ProbeAlso: Optical SpectroscopyThe 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. | Device | Spectral-Diagnosis |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2019.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Migden, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2019.