A Phase I/II Study of Disappearing Markers for Daily Radiation Treatment Delivery
Barbara Ann Karmanos Cancer Institute
Summary
The goal of this clinical trial is to learn if tattoos applied with Magic Ink is as safe as commercially available standard tattoo ink for the purpose of radiation in women with breast cancer undergoing radiation treatment. The main questions are: * Is the Magic Ink as safe as standard tattoo ink * Does Magic Ink continue to function and remain visible for radiation therapists during the treatment Participants will be consented and given a skin assessment. Once enrolled participants will be administered the Magic Ink tattoo instead of the standard tattoo ink in preparation for their radiation treatment. Participants will also complete a survey regarding body image. Skin assessment will occur again after the first week of radiation and at 3 months later. Throughout the radiation therapy the medical physicist will complete surveys about ease of set-up of the equipment.
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Participant must have histologically or cytologically confirmed stage 0 ductal carcinoma in situ (DCIS), I, II or III breast cancer and be planning to undergo radiation therapy (RT) after surgery * Participants must be 18 years of age or older * Participant must be able to understand a written informed consent document and be willing to sign it * Participant must be assigned female at birth * Participant must have a Karnofsky performance score of greater than or equal to 70% * Women of child bearing potential must agree to avoid becoming pregnant through defined periods…
Interventions
- OtherMagic Ink
A novel ink that is only visible when exposed to Ultraviolet light and can be hidden using white light will be inserted into the dermis to tattoo a radiation guidance tattoo into the skin of the participant
Location
- Karmanos Cancer InstituteDetroit, Michigan