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NCT07201376 · ClinicalTrials.gov registry record
Assessment of Skin Lesions Using a Tissue Oxygen Imager Based on Protoporphyrin IX (PPIX) Fluorescence. This is an Open-label, Non-randomized, Feasibility Study That Includes a One-time Application of an FDA Approved Medication Followed by Local Imaging for Benign Skin Growth and Lesions Clinically
A clinical trial of Non-melanoma Skin Cancer (NMSC) and Benign Skin Growth, sponsored by Dartmouth-Hitchcock Medical Center.
- Recruiting
- Registry status
- 125
- Enrollment target
- 1
- Study location
NCT07201376: Recruiting study of Non-melanoma Skin Cancer (NMSC) and Benign Skin Growth, sponsored by Dartmouth-Hitchcock Medical Center.
NCT07201376 is a study of Non-melanoma Skin Cancer (NMSC) and Benign Skin Growth that is actively recruiting participants, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 125 participants, below the 160-participant average among 3 other Non-melanoma Skin Cancer (NMSC) trials with a reported enrollment target (22% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07201376, a study of Non-melanoma Skin Cancer (NMSC) and Benign Skin Growth, is actively recruiting participants, sponsored by Dartmouth-Hitchcock Medical Center.
- RECRUITING
- Registry status
- 125 participants
- Enrollment target
- 1
- Study location
Study Summary
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).
Primary Outcome
Advancing our understanding of these cancers and developing effective strategies for diagnosis. The study will use aminolaevulinic acid (ALA) as a source of protoporphyrin IX (PpIX) to allow the detection of hypoxia signal. More specifically, the oxygen imager gathers the delayed fluorescence (DF) of PpIX, which intensity is inversely proportional to tissue mitochondrial oxygen content. This provides qualitative contrast on hypoxic regions with submillimeter spatial resolution. Transient hypoxia
Conditions Studied
Interventions
- DRUG Ameluz 10% Topical Gel
- DEVICE Protoporphyrin IX
Study Locations (1)
New Hampshire
- Dartmouth Hitchcock - Lebanon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2025-11-14 |
| Est. Completion | 2027-11 |
What NCT07201376 shows while recruiting
NCT07201376 is an observational study that tracks outcomes without assigning an intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap, below the 160-participant average among 3 other Non-melanoma Skin Cancer (NMSC) trials with a reported enrollment target (22% lower).
The record links to 2 conditions, with Non-melanoma Skin Cancer (NMSC) appearing as the primary indexed condition, and to 2 interventions - of which Ameluz 10% Topical Gel is the first listed.
NCT07201376 reports a single indexed study location in New Hampshire.
Frequently Asked Questions
What is clinical trial NCT07201376 about?
NCT07201376 is a clinical study titled "Assessment of Skin Lesions Using a Tissue Oxygen Imager Based on Protoporphyrin IX (PPIX) Fluorescence. This is an Open-label, Non-randomized, Feasibility Study That Includes a One-time Application of an FDA Approved Medication Followed by Local Imaging for Benign Skin Growth and Lesions Clinically". 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 is the current status of trial NCT07201376?
This trial is currently recruiting. The enrollment target is 125 participants. The study started on 2025-11-14. Estimated completion is 2027-11.
What conditions does trial NCT07201376 study?
This clinical trial studies the following conditions: Non-melanoma Skin Cancer (NMSC), Benign Skin Growth.
What interventions are being tested in trial NCT07201376?
The interventions under investigation include: Ameluz 10% Topical Gel (DRUG), Protoporphyrin IX (DEVICE).
Who is sponsoring clinical trial NCT07201376?
This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07201376 being conducted?
This trial has 1 study location across New Hampshire. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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