A Phase I/II Study of Disappearing Markers for Daily Radiation Treatment Delivery

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 during the course of RT and must meet one of the following:

‣ Surgically sterile (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy

⁃ Post-menopausal, defined as no menses for at least 12 months prior to the screening visit without alternative medical causation

⁃ Agree to practice true abstinence from sexual intercourse

⁃ Not in a sexual relationship in which the may become pregnant (i.e., same-sex relationship)

⁃ If they are childbearing potential, agree to use at least one highly effective and at least one additional method of contraception.

• For the first six participants only: Participant must have a Fitzpatrick Skin Tone Scale of 5 or 6

Locations
United States
Michigan
Karmanos Cancer Institute
RECRUITING
Detroit
Contact Information
Primary
Michael Dominello, DO
Mdominel@med.wayne.edu
3135769546
Time Frame
Start Date: 2025-08-18
Estimated Completion Date: 2026-08-08
Participants
Target number of participants: 30
Treatments
Experimental: Magic Ink tattoo
Magic Ink tattoo ink which is only visible when exposed to ultraviolet light will be used to mark radiation guidance
Related Therapeutic Areas
Sponsors
Leads: Barbara Ann Karmanos Cancer Institute

This content was sourced from clinicaltrials.gov