CLARITY Study - PMCF Study

Launched by LABORATOIRES BIOTIC PHOCEA · Feb 26, 2025

Keywords

ClinConnect Summary

The CLARITY Study is a clinical trial that aims to evaluate the safety and effectiveness of a special type of ink called RADSAFE® inks, which are used to mark the area of the body that will receive radiation therapy for cancer treatment. This study is important because it helps ensure that the inks are safe for patients and work well for correctly aligning radiation treatment.

To participate in this trial, you must be at least 18 years old and a cancer patient who needs radiation therapy. You should also be able to give written consent and have healthy skin where the ink will be applied. However, certain conditions may prevent you from joining, such as having an allergy to the ink's ingredients or a previous tattoo in the treatment area. If you decide to participate, you can expect to have the ink applied to your skin as part of your treatment plan, and the study will closely monitor your safety and how well the ink performs during your therapy. This trial is currently not recruiting participants, but it will be open to all genders.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female ≥18 years old, Cancer patient requiring radiotherapy, Patient requiring medical tattoo for treatment alignment, Intact skin at site of standard radiotherapy tattoos, ECOG performance status ≤2 (Karnofsky ≥60%), Able to provide written informed consent, Affiliated patient or beneficiary of a social security scheme.
• Exclusion Criteria:
• • Previous medical tattoo of the targeted zone of treatment Known allergy to pigment ingredients, Infected or diseased skin, past or present, Affected organs close to the skin (eyes), Hypertrophic scars at site of radiotherapy tattoos, Carrying cardiac implant, Patient with blood clotting disorders, No consent to study participation, Under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision, An existing medical condition that, in the opinion of the Investigator, may put the subject at risk or compromise their participation in the study, Psychiatric illness/social situations that would limit compliance with study requirements, Females who are pregnant, lactating, or unwilling to use adequate birth control for the duration of the study, Personal objection to medical tattooing, Participation to another drug or medical device clinical interventional study that may interfere with the clinical investigation objectives.