Dartmouth-Hitchcock Medical Center and Dartmouth College have announced a new clinical trial exploring advanced imaging technology to assess benign skin growths and non-melanoma skin cancer (NMSC). Utilizing a combination of Protoporphyrin IX fluorescence imaging and Ameluz 10% Topical Gel, this feasibility study aims to analyze tissue oxygenation following the application of the FDA-approved medication. The trial is currently listed as “Not yet recruiting,” signaling readiness for upcoming participation.
What is the purpose?
This open-label, non-randomized clinical trial investigates the effectiveness of a tissue oxygen imaging methodology using fluorescence generated by Protoporphyrin IX (PPIX). The study aims to provide clinical insights into the response of benign skin lesions and non-melanoma skin cancer to an FDA-approved medication, Ameluz 10% Topical Gel, in combination with localized imaging techniques.
How will the trial be conducted?
Participants will undergo a one-time application of Ameluz 10% Topical Gel, a photosensitizing agent approved by the FDA. This is followed by imaging using the Protoporphyrin IX-based device to assess tissue oxygenation levels in the treated skin regions. This imaging system relies on fluorescence properties to gather data, which could prove valuable in enhancing diagnostic accuracy and treatment monitoring.
It is important to note that this is a feasibility study, meaning it is designed to assess the practicality of this imaging method and its integration into clinical settings. No randomization will be involved, allowing investigators to focus on direct results from controlled parameters.
Who should pay attention?
The trial is relevant to regulatory teams, clinical researchers, and medical professionals focusing on dermatology and oncology. Insights gained from this study could influence future regulatory decisions, provide data for advancing imaging technologies, and refine protocols for treating skin abnormalities.
Additionally, it may be of interest to medical device and pharmaceutical companies involved in innovations related to diagnostic tools and dermatologic treatments. Stakeholders within academia and health care systems might also find its potential impact noteworthy.
FAQ
1. What conditions are being studied?
The trial focuses on non-melanoma skin cancer (NMSC) and benign skin growths.
2. What interventions are involved?
The study utilizes Ameluz 10% Topical Gel and a Protoporphyrin IX fluorescence device for imaging.
3. Who is sponsoring this trial?
Dartmouth-Hitchcock Medical Center and Dartmouth College are the sponsors.
4. When will recruitment begin?
As of now, the study is listed as “Not yet recruiting.” Future updates will provide more details on enrollment timelines.
Conclusion
This clinical trial introduces innovative imaging technology that aligns with contemporary dermatologic and oncologic approaches. Its feasibility-focused design holds the promise of enhancing diagnostic accuracy for skin lesions while paving the way for regulated adoption in medical settings. Stakeholders are encouraged to follow updates on ClinicalTrials.gov for recruitment and additional study details.
Disclaimer
This article is intended for professionals. It does not constitute legal advice or specific medical guidance. Please consult official documentation from ClinicalTrials.gov or regulatory agencies for detailed information.
Access more details here
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07201376?term=medical+device