Clinical trial · Observational
Pilot Study of Infrared Imaging of Cutaneous Melanoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Design: this is a pilot study of infrared imaging of cutaneous lesions in patients and volunteers with and without clinically detectable melanoma, and with one or more palpable cutaneous lesions eligible for this imaging study. Participants will be evaluated with infrared camera imaging at cutaneous sites with known melanoma deposits, suspected melanoma deposits that are to be biopsied, or at cutaneous sites with other lesions, including other skin cancers, benign inflammatory lesions, benign neoplastic lesions (lipomas, epidermal cysts, dermatofibromas, scar, healing wound, etc.).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- infrared imaging of cutaneous lesions
- description
- patients and volunteers with cutaneous lesions, with and without clinically detectable melanoma, and with one or more palpable cutaneous lesions
Primary outcomes (1)
- measure
- preliminary estimate sensitivity of infrared imaging in detecting melanoma metastasis as function of lesion diameter
- timeFrame
- one day - 24 hours
Secondary outcomes (1)
- measure
- to obtain preliminary estimate of specificity of infrared imaging for detection of melanoma metastasis
- timeFrame
- one day-24 hours
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients or volunteers with or without a history of melanoma. * One or more palpable skin or subcutaneous lesions for which at least one of the following is true: * A tissue diagnosis has been made for the lesion(s) in question, by prior cytologic or histologic evaluation (Category A1). * A tissue diagnosis will be obtained for the lesion(s) in question by cytologic or histologic evaluation (Category A2). * A tissue diagnosis is not available, but a clinical diagnosis of melanoma or benign lesion is available with a high degree of confidence. Examples are hemangiomas, skin tags, seborrheic keratoses, dermatofibromas, lipomas, or growing pigmented skin lesions that are comparable to other cutaneous metastases of melanoma in the same patient (Category B). * All patients must have the ability and willingness to give informed consent and must be age 18 years or older at the time of study entry. Exclusion Criteria: * Known or suspected allergy to the adhesive skin markers or water-soluble ink used for the labeling of lesions. * Very fragile skin that may be susceptible to injury from adhesive markers. * Patients in whom there is a medical contraindication or potential problem in complying with the requirements of the protocol, in the opinion of the investigator.
References
Publications (0)
Data not yet available