NCT07095114 · Barbara Ann Karmanos Cancer Institute
A Study of Disappearing Markers for Daily Radiation Treatment Delivery for Breast Cancer Patients.
What this study is about
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.
View original scientific description
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
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 with active chronic skin diseases such as psoriasis. Participants with inactive or controlled skin diseases are eligible for this study
- Participants that are pregnant or breastfeeding. If a participant wishes to participate in this study, breastfeeding should be discontinued
- Participants with a BMI greater than 44.5 as calculated within six months prior to the starting of the study. If there are multiple BMI measurements available in the chart, the most recent will be used to determine eligibility.
Where
- Detroit, Michigan
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 18, 2025 · Source of record for eligibility and locations