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Recruiting

NCT Number: NCT07095114

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

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.

Recruiting

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Key information

Conditions

Ductal Carcinoma in Situ Adenocarcinoma Breast Carcinoma In Situ Breast Diseases Breast Neoplasms Carcinoma Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial Skin Diseases Skin and Connective Tissue Diseases Stage I Breast Cancer Stage II Breast Cancer Stage III Breast Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location status: Recruiting

Location contact

Michael Dominello, DO

CONTACT

[email protected]

313-576-9546

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Magic Ink

Other

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

Primary outcomes

  1. Safety of Magic Ink

    Time frame: 3 months after completion of Radiation Therapy

    Number of participants with treatment related adverse events as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0)

Secondary outcomes

  1. Efficacy of Magic Ink

    Time frame: 3 months after the completion of Radiation Therapy

    Ease of radiation treatment (RT) setup. Participants will be categorized as "difficult" or "easy" setups. Difficult setups are setups with greater than 15% of the films for the treatment course result in a physician flag or reimaging based on clinically unacceptable or borderline acceptable setup.

  2. Body Image Score

    Time frame: 3 months after the completion of Radiation Therapy

    Participants will complete a Body Image survey at baseline (prior to treatment) and 3 months after the completion of radiation therapy. The body image scale survey is a 10 question Likert scale where participants give a rating of Not at all, A little, Quite a bit or Very much. Responses will be compared to historical controls

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Dominello, DO

CONTACT

[email protected]

3135769546

Sponsors and collaborators

Lead sponsor

Barbara Ann Karmanos Cancer Institute

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 31, 2025
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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