Disappearing markers for daily breast radiation delivery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with DCIS or stage I–III breast cancer who plan postoperative radiation will receive tattoos made with Magic Ink instead of standard tattoo ink to guide daily treatment setup. Participants will complete a baseline skin assessment and a body-image survey, with repeat skin checks after the first week of radiation and again at three months. Medical physicists will complete surveys during the course of therapy about the ease of patient setup and mark visibility. The trial is conducted at the Barbara Ann Karmanos Cancer Institute and focuses on safety and practical usability of the disappearing ink.

Why it matters

Who can join: the full rules

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 it's running

• Karmanos Cancer Institute
  Detroit, Michigan, United States Recruiting

Study contacts

• Principal investigator: Michael Dominello, DO — Wayne State University
• Study coordinator: Michael Dominello, DO
• Email: Mdominel@med.wayne.edu
• Phone: 3135769546

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.