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

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.

Study Overview

• Status: Recruiting
• Conditions: Stage I Breast Cancer; Stage II Breast Cancer; Ductal Carcinoma in Situ; Stage III Breast Cancer
• Intervention / Treatment: Other: Magic Ink

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Dominello, DO; Phone Number: 3135769546; Email: Mdominel@med.wayne.edu

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Recruiting
      • Karmanos Cancer Institute
      • Contact: Michael Dominello, DO; Phone Number: 313-576-9546; Email: mdominel@med.wayne.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Magic Ink tattoo; Magic Ink tattoo ink which is only visible when exposed to ultraviolet light will be used to mark radiation guidance	Other: Magic 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of Magic Ink	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)	3 months after completion of Radiation Therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of Magic Ink	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.	3 months after the completion of Radiation Therapy
Body Image Score	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	3 months after the completion of Radiation Therapy

Collaborators and Investigators

• Sponsor: Barbara Ann Karmanos Cancer Institute
• Investigators: Principal Investigator: Michael Dominello, DO, Wayne State University

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2025
• Primary Completion (Estimated): August 8, 2026
• Study Completion (Estimated): August 8, 2026

Study Registration Dates

• First Submitted: July 15, 2025
• First Submitted That Met QC Criteria: July 23, 2025
• First Posted (Actual): July 31, 2025

Study Record Updates

• Last Update Posted (Estimated): September 18, 2025
• Last Update Submitted That Met QC Criteria: September 12, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Breast Carcinoma In Situ; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Skin Diseases; Breast Diseases; Carcinoma; Neoplasms, Ductal, Lobular, and Medullary; Carcinoma in Situ; Skin and Connective Tissue Diseases; Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating
• Other Study ID Numbers: 2025-034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No