Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT07095114

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

Led by Barbara Ann Karmanos Cancer Institute · Updated on 2025-09-18

30

Participants Needed

1

Research Sites

50 weeks

Total Duration

On this page

AI-Summary

What this Trial 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. 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically or cytologically confirmed stage 0 ductal carcinoma in situ (DCIS), I, II, or III breast cancer
  • Planning to undergo radiation therapy after surgery
  • 18 years of age or older
  • Able to understand and willing to sign informed consent
  • Assigned female at birth
  • Karnofsky performance score of 70% or higher
  • Women of childbearing potential must agree to avoid pregnancy during radiation therapy and meet at least one of the following:
    • Surgically sterile (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy)
    • Post-menopausal (no menses for at least 12 months without other cause)
    • Agree to practice true abstinence from sexual intercourse
    • Not in a sexual relationship where pregnancy is possible
    • Use at least one highly effective and one additional method of contraception
  • For the first six participants only: Fitzpatrick Skin Tone Scale of 5 or 6
Not Eligible

You will not qualify if you...

  • Prior radiation treatment to the affected breast
  • History of allergic reaction or hypersensitivity to any tattoo ink
  • Active chronic skin diseases such as psoriasis (inactive or controlled skin diseases allowed)
  • Pregnant or breastfeeding (breastfeeding must be discontinued to participate)
  • Body mass index (BMI) greater than 44.5 within six months before the study start

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Karmanos Cancer Institute

Detroit, Michigan, United States, 48201

Actively Recruiting

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Research Team

M

Michael Dominello, DO

CONTACT

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