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A phase I/II study of disappearing markers for daily radiation treatment delivery
Cancer Categories
Breast
Karmanos Trial ID
2025-034
NCT ID
NCT07095114
Age Group
Adult
Scope
Local
Phase
Phase I
Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
Phase I/II
Principal Investigator
Michael
Dominello, D.O.
Oncology - Radiation
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Objective:
Primary Objective:
The primary objective of the study is to test the hypothesis that tattoos applied using Magic Ink will be just as safe as those made with a commercially available standard tattoo ink for the purpose of RT.
Secondary Objective:
The secondary objective of this study will verify that Magic Ink continues to function and remain adequately visible for radiation therapists to effectively use the tattoos as landmark guidance throughout standard RT.
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NCI Dictionary of Cancer Terms
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Eligibility
Locations
Applicable Disease Site
Therapies | Drugs | Devices
Eligibility
Eligibility
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
Locations
Locations
Karmanos Cancer Institute - Detroit Headquarters
4100 John R
Detroit, MI 48201
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Phone:
1-800-527-6266
Applicable Disease Site
Applicable Disease Site
Breast
Therapies, Drugs, Devices
Therapies | Drugs | Devices
Drugs
Magic Ink
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