Actively Recruiting
A Phase I/II Study of Disappearing Markers for Daily Radiation Treatment Delivery in Breast Cancer Patients
Led by Barbara Ann Karmanos Cancer Institute · Updated on 2025-09-18
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and visibility of a new tattoo ink called Magic Ink compared to standard tattoo ink in women with breast cancer undergoing radiation therapy. The study focuses on whether Magic Ink is as safe as standard ink and if it remains visible for radiation therapists throughout treatment. This research involves women with ductal carcinoma in situ or stage I to III breast cancer preparing for radiation after surgery. Participants will receive a Magic Ink tattoo that is visible only under ultraviolet light, used for radiation guidance during therapy. This ink differs from standard ink by being hidden under normal white light. The study includes skin assessments before and after tattoo application, and during radiation therapy. Surveys about body image and equipment setup ease by medical physicists will also be collected. Throughout the study, participants will have skin evaluations at enrollment, after the first week of radiation, and three months post-treatment. They will complete body image surveys, while medical staff will assess the practicality of using Magic Ink for radiation setup. The main outcome measured is the safety of Magic Ink three months after radiation therapy, along with its effectiveness and impact on body image. The study spans from enrollment through several months of follow-up to monitor these factors.
CONDITIONS
Brief Title
A Study of Disappearing Markers for Daily Radiation Treatment Delivery for Breast Cancer Patients.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must have confirmed stage 0 ductal carcinoma in situ (DCIS), or stage I, II, or III breast cancer and be planning radiation therapy after surgery
- Participant must be 18 years of age or older
- Participant must be able to understand and willing to sign informed consent
- Participant must be assigned female at birth
- Participant must have a Karnofsky performance score of at least 70%
- Women able to bear children must agree to avoid pregnancy during radiation therapy and meet one of the listed contraception or sterilization conditions
- For the first six participants only: Participant must have a Fitzpatrick Skin Tone Scale of 5 or 6
You will not qualify if you...
- Participants who have had prior radiation treatment to the affected breast
- Participants with allergic reactions or hypersensitivity to any tattoo ink
- Participants with active chronic skin diseases such as psoriasis (inactive or controlled skin diseases allowed)
- Participants who are pregnant or breastfeeding; breastfeeding must be stopped to participate
- Participants with a BMI over 44.5 measured within six months before study start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of radiation therapy
Participants receive a Magic Ink tattoo visible only under ultraviolet light to guide daily radiation therapy for breast cancer.
Daily visits for radiation treatment
Duration - 3 months after completion of Radiation Therapy
Participants are monitored for safety, efficacy of the Magic Ink, and body image outcomes after completing radiation therapy.
Approximately 1 follow-up visit
Trial Site Locations
Total: 1 location
1
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
Research Team
M
Michael Dominello, DO
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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