Non-Melanoma Skin Cancer (NMSC)CancerSkinDrugDevice
What this study is
The primary objective of this study is the evaluation of the efficacy of the tissue oxygen imager based on PpIX DF in differentiating benign skin growth from non-melanoma skin cancer (NMSC).
What's being tested
- Ameluz 10% Topical Gel
Intervention · DRUG
One-time topical application of 10% Ameluz gel for up to 1 hour
- Protoporphyrin IX
Intervention · DEVICE
Tissue oxygen imaging using protoporphyrin IX (PIX), a non-significant risk device.
Study details
- Official title
- Tissue Oxygen Imager
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Conditions
- Non-Melanoma Skin Cancer (NMSC) · Benign Skin Growth
- Enrolling
- 125 people
- Starts
- 2025-11-14
- Est. completion
- 2027-11
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers AcceptedYou may qualify if
- Adults ≥ 18 years of age.
- Histologic proof of non-melanoma skin cancer. Patients with different skin tones based on the Fitzpatrick Scale, who present with skin growth or lesions and are scheduled for resection.
- As determined by the enrolling physician or study team member, the patient must have the willingness and ability to understand and comply with study procedures.
- Women of childbearing potential (WOCBP): Premenopausal females who had at least one menstrual cycle in the past 12-months and capable to become pregnant, must have a negative serum beta-HCG pregnancy test result within seven days prior to start of study.
- Lesions must measure between 5 mm and 3 cm in diameter.
You can't join if
- Patients who are <18 years of age
- Adults who are unable to provide informed consent.
- Known allergy to Ameluz
- Photosensitivity or photodermatoses or similar conditions.
- Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment and/or comply with study protocol, in the opinion of the investigator
- Known hypersensitivity to porphyrins or to any component of Ameluz, including soya bean phosphatidylcholine.
- Females who are currently breast-feeding
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openDartmouth Hitchcock
Lebanon, New Hampshire, United States
- Dylan Parker, MD · Contact6036532209Dylan.J.Parker@Hitchcock.org
Recruiting
Study team
Sponsor
Dartmouth-Hitchcock Medical Center
Study ID STUDY02002181
Principal investigator
Michael Chapman, MD
Dartmouth
Have questions? The contacts above can answer them before you apply.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.