A Study of Disappearing Markers for Daily Radiation Treatment Delivery for Breast Cancer Patients. (NCT07095114) | Clinical Trial Compass
RecruitingNot Applicable
A Study of Disappearing Markers for Daily Radiation Treatment Delivery for Breast Cancer Patients.
United States30 participantsStarted 2025-08-18
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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
Exclusion Criteria:
* Participants who have received prior radiation treatment to the affected breast.
* Participants with a history of allergic reaction or hypersensitivity attributed to any tattoo ink
* Participants wit…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety of Magic Ink
Timeframe: 3 months after completion of Radiation Therapy