RecruitingNot ApplicableNCT07095114

A Study of Disappearing Markers for Daily Radiation Treatment Delivery for Breast Cancer Patients.

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


Sponsor

Barbara Ann Karmanos Cancer Institute

Enrollment

30 participants

Start Date

Aug 18, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of temporary skin marker — called a "disappearing marker" — used to guide where radiation therapy is aimed during breast cancer treatment. Unlike permanent tattoos currently used to line up patients for radiation, this marker gradually fades, which may be preferred by many patients. Researchers want to see whether these temporary markers work just as accurately. **You may be eligible if...** - You are 18 years or older and assigned female at birth - You have been diagnosed with breast cancer (stage 0 through III) and are planning to receive radiation therapy after surgery - Your general health is reasonably good (Karnofsky performance score 70% or higher) - You have not received prior radiation to the affected breast **You may NOT be eligible if...** - You have previously had radiation to the affected breast - You have a known allergy to tattoo ink - You have active chronic skin diseases such as psoriasis (controlled skin conditions are acceptable) - You are pregnant or breastfeeding - Your BMI is above 44.5 Note: The first 6 participants must have a darker skin tone (Fitzpatrick scale 5 or 6). Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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


Locations(1)

Karmanos Cancer Institute

Detroit, Michigan, United States

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NCT07095114


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