A Study of the Benefits of Automated Total Body Imaging called DermSpectra
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 14-003905
Sponsor Protocol Number: 14-003905
About this study
The purpose of this study is to compare an automated way of taking photographs of the skin to the standard manual process performed by a Mayo Medical Photographer. The automated process will use a whole body imaging system called DermSpectra. DermSpectra is an FDA approved whole body digital imaging system and will be operated by a Mayo Clinic staff member.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Study group 1
- Fulfill high-risk criteria for melanoma, including atypical nevi phenotype and/or history of melanoma and/or family history of melanoma with additional risk factors such as dysplastic nevi or multiple atypical nevi, including atypical mole syndrome (>50 melanocytic nevi with at least one of the lesions measuring > 8mm in diameter).
- Study group 2
- Provider selected at office visit
- Group 1 inclusion criteria and /or skin disease that is identified by the participating provider as involving a widespread portion of the body surface area (multiple body sites) and /or with potential clinical benefit from digital imaging documentation
Exclusion Criteria
- Under age 18 years
- History of claustrophobia
- Unable to stand in the imaging station and follow the instructions for total body imaging when using the DermSpectra system
- Pregnancy
- Focal disease (e.g. < 3 moles, < 50% of an anatomical site or limited body sites of skin condition)
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator James Yiannias, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available