Skin CancerNCT00526032
Melanoma Detection by Oblique-Incidence Optical Spectroscopy
An observational study of Skin Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objectives: To establish a statistically significant database: With Spectroscopic Oblique-Incidence Reflectometry (OIR) experimental system, we will obtain OIR spatio-spectral images of 1,000 human skin non-melanocytic and melanocytic lesions that, based on clinical diagnosis, are routinely biopsied and… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Skin Cancer
- What is being tested?
- OIR Imaging
- Type of treatment
- Surgery or procedure
- How many people
- 490 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Jan 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants having lesions on the skin that may be cancerous.
Who may be able to join
- Patients of any age, male or female, who are having a skin exam and are found to have a suspicious skin lesion on examination of their skin
- Patients who agree to participate and sign the informed consent
Who cannot join
- Patients who do not have a suspicious skin lesion
- Patients who have not signed the informed consent and have agreed to participate
Trial locations and contacts
1 site in 1 country.
About this study
Primary Objectives:
- To establish a statistically significant database: With Spectroscopic Oblique-Incidence Reflectometry (OIR) experimental system, we will obtain OIR spatio-spectral images of 1,000 human skin non-melanocytic and melanocytic lesions that, based on clinical diagnosis, are routinely biopsied and submitted for histopathologic diagnosis and of the adjacent normal skin for self-referencing. The experimental database will contain demographic information, clinical diagnoses, clinical images, OIR images, histopathologic diagnoses, and morphometric data on the lesions.
- To develop and validate a diagnostic algorithm:
Read more
- Classification: A subset (~50%) of OIR images collected will be used to complete the development of state-of-the-art image processing algorithms to extract robustly effective diagnostic features.
- Blind Testing and Evaluation: The algorithms established will be evaluated and validated in a prospective blind-test fashion using the complementary subset of the database that was not involved in designing the classifier. The sensitivity and specificity of the classification system will be evaluated based on the receiver-operating-characteristic (ROC) curve.
- To identify the pathophysiologic parameters responsible for the diagnostic optical features: The anatomic and physiologic sources of the diagnostic optical signatures will be identified by comparative analyses using the OIR images, microscopic histomorphometric techniques and theoretical modeling to test the following hypotheses:
- The calculated differences in hemoglobin oxygen saturation.
- Comparisons of the calculated size distributions of skin scattering centers with histologic and morphometric analyses of various cellular and tissue components of the skin lesions.
- The relative densities and distributions of the different anatomic and physiologic diagnostic features within the interrogation volumes are important diagnostic factors in OIR.
Read the detailed description
The OIR imaging probe is designed to reflect light in a special way in order to take pictures of pigmented skin.
As part of your standard of care, your physician will check all skin lesions that may possibly be cancerous or pre-cancerous. Your physician will also check any non-cancerous lesions that are being removed for cosmetic reasons, such as warts and freckles.
If you agree to take part in this study, the study doctor will decide which lesions will be biopsied, as well as which lesions are eligible to be imaged. Pictures of the lesions (as well as healthy tissue nearby) will first be taken using a digital camera. The imaging probe and the area of the skin to be imaged will be cleaned with alcohol. After the imaging probe is placed over the lesion, a drop of baby oil will be applied to the skin. The imaging probe will then be lowered into contact with the skin, and the study staff will begin imaging. Twenty (20) images from 4 different positions will be taken per lesion.
Care will be taken to make sure that you cannot be identified from these images. For example, the study staff will avoid taking pictures of the face unless there are lesions there. After each lesion is imaged, the imaging device will be taken away and the skin surface cleaned. The entire imaging procedure, including preparation time, will take about 5 minutes per lesion.
Any hair on or around your lesions will be shaved or trimmed, if necessary. After all of the imaging is over, your lesion(s) will be biopsied. Your study doctor will decide which lesions require this kind of treatment as part of your standard care. Depending on what the study doctor decides, you will have either saucerization biopsies or excisional biopsies. A saucerization biopsy removes the entire lesion by cutting under it in a "scoop-like" manner. An excisional biopsy "cuts away" the entire lesion along with part of the surrounding skin.
A pathologist will receive your biopsied tissue and perform routine tests on the tissue. The test results will be available to the study doctor. Depending on whether the results are negative or positive, you may be informed of the results, as the biopsies are standard of care.
The images of your skin will be used for research to try to make the imaging probe more effective.
If you end your participation in this study early, your photographs and information will be removed from the researchers' database at that time. However, a record of your participation will remain in the database.
After all of the imaged lesions are biopsied, your participation in this study will be over.
This is an investigational study. The OIR imaging probe has not been approved by the FDA. Up to 1,000 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Skin Cancer
- Being tested
- OIR Imaging
- Keywords
- Skin Cancer, Cancerous skin lesions, Melanoma Detection, Spectroscopic Oblique-Incidence Reflectometry, OIR Imaging Probe
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OIR ImagingProcedure or surgery
Also called imaging probe
Images from 4 different positions will be taken per lesion. The entire imaging procedure will take about 5 minutes per lesion.
| Study group | Role | What they receive |
|---|---|---|
| Spectroscopic Oblique-Incidence Reflectometry (OIR) | Not described Receives: Procedure: OIR Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test OIR diagnostic medical tool (imaging probe) designed for early detection of skin cancers
Observational study where patients getting skin biopsies of suspicious pigmented lesions were asked if their moles could be imaged with incidence optical spectroscopy. The light that was reflected back out was analyzed and hypothesized to differ from normal skin.
Measured: 4 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2007 (estimated)
- Study startSep 2006
- Primary completionJan 2012
- Study completionJan 2012
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 only
- Time perspective
- Prospective
- Enrolment
- 490 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Madeleine Duvic, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00526032
- Sponsor's protocol ID
- 2006-0564
- Status last verified
- Jan 2012
- First submitted
- 5 Sep 2007
- Last updated
- 31 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melanoma Detection by Oblique-Incidence Optical Spectroscopy
- ClinicalTrials.gov ID
- NCT00526032
- Acronym / sponsor ID
- 2006-0564
- Conditions
- Skin Cancer
- Keywords
- Skin Cancer, Cancerous skin lesions, Melanoma Detection, Spectroscopic Oblique-Incidence Reflectometry, OIR Imaging Probe
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 490 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 6 Sep 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.
Primary Objectives:
- To establish a statistically significant database: With Spectroscopic Oblique-Incidence Reflectometry (OIR) experimental system, we will obtain OIR spatio-spectral images of 1,000 human skin non-melanocytic and melanocytic lesions that, based on clinical diagnosis, are routinely biopsied and submitted for histopathologic diagnosis and of the adjacent normal skin for self-referencing. The experimental database will contain demographic information, clinical diagnoses, clinical images, OIR images, histopathologic diagnoses, and morphometric data on the lesions.
- To develop and validate a diagnostic algorithm:
- Classification: A subset (~50%) of OIR images collected will be used to complete the development of state-of-the-art image processing algorithms to extract robustly effective diagnostic features.
- Blind Testing and Evaluation: The algorithms established will be evaluated and validated in a prospective blind-test fashion using the complementary subset of the database that was not involved in designing the classifier. The sensitivity and specificity of the classification system will be evaluated based on the receiver-operating-characteristic (ROC) curve.
- To identify the pathophysiologic parameters responsible for the diagnostic optical features: The anatomic and physiologic sources of the diagnostic optical signatures will be identified by comparative analyses using the OIR images, microscopic histomorphometric techniques and theoretical modeling to test the following hypotheses:
- The calculated differences in hemoglobin oxygen saturation.
- Comparisons of the calculated size distributions of skin scattering centers with histologic and morphometric analyses of various cellular and tissue components of the skin lesions.
- The relative densities and distributions of the different anatomic and physiologic diagnostic features within the interrogation volumes are important diagnostic factors in OIR.
Detailed description
The OIR imaging probe is designed to reflect light in a special way in order to take pictures of pigmented skin.
As part of your standard of care, your physician will check all skin lesions that may possibly be cancerous or pre-cancerous. Your physician will also check any non-cancerous lesions that are being removed for cosmetic reasons, such as warts and freckles.
If you agree to take part in this study, the study doctor will decide which lesions will be biopsied, as well as which lesions are eligible to be imaged. Pictures of the lesions (as well as healthy tissue nearby) will first be taken using a digital camera. The imaging probe and the area of the skin to be imaged will be cleaned with alcohol. After the imaging probe is placed over the lesion, a drop of baby oil will be applied to the skin. The imaging probe will then be lowered into contact with the skin, and the study staff will begin imaging. Twenty (20) images from 4 different positions will be taken per lesion.
Care will be taken to make sure that you cannot be identified from these images. For example, the study staff will avoid taking pictures of the face unless there are lesions there. After each lesion is imaged, the imaging device will be taken away and the skin surface cleaned. The entire imaging procedure, including preparation time, will take about 5 minutes per lesion.
Any hair on or around your lesions will be shaved or trimmed, if necessary. After all of the imaging is over, your lesion(s) will be biopsied. Your study doctor will decide which lesions require this kind of treatment as part of your standard care. Depending on what the study doctor decides, you will have either saucerization biopsies or excisional biopsies. A saucerization biopsy removes the entire lesion by cutting under it in a "scoop-like" manner. An excisional biopsy "cuts away" the entire lesion along with part of the surrounding skin.
A pathologist will receive your biopsied tissue and perform routine tests on the tissue. The test results will be available to the study doctor. Depending on whether the results are negative or positive, you may be informed of the results, as the biopsies are standard of care.
The images of your skin will be used for research to try to make the imaging probe more effective.
If you end your participation in this study early, your photographs and information will be removed from the researchers' database at that time. However, a record of your participation will remain in the database.
After all of the imaged lesions are biopsied, your participation in this study will be over.
This is an investigational study. The OIR imaging probe has not been approved by the FDA. Up to 1,000 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spectroscopic Oblique-Incidence Reflectometry (OIR) | – | Procedure: OIR Imaging |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants having lesions on the skin that may be cancerous.
Key inclusion criteria (2 listed)
- Patients of any age, male or female, who are having a skin exam and are found to have a suspicious skin lesion on examination of their skin
- Patients who agree to participate and sign the informed consent
Key exclusion criteria (2 listed)
- Patients who do not have a suspicious skin lesion
- Patients who have not signed the informed consent and have agreed 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 |
|---|---|---|
| OIR ImagingAlso: imaging probeImages from 4 different positions will be taken per lesion. The entire imaging procedure will take about 5 minutes per lesion. | Procedure or surgery | Spectroscopic Oblique-Incidence Reflectometry (OIR) |
Primary outcome
Test OIR diagnostic medical tool (imaging probe) designed for early detection of skin cancers
Time frame: 4 Years
Observational study where patients getting skin biopsies of suspicious pigmented lesions were asked if their moles could be imaged with incidence optical spectroscopy. The light that was reflected back out was analyzed and hypothesized to differ from normal skin.
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 31 Jan 2012.
- MD Anderson Cancer CenterLink provided by the sponsor.
Related trials for Skin Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
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.
Madeleine Duvic, 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 2 inclusion and 2 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 31 Jan 2012. 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?
Test OIR diagnostic medical tool (imaging probe) designed for early detection of skin cancers (time frame: 4 Years). 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 31 Jan 2012.