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New treatment option for Ductal Carcinoma in Situ
Official title A Study of Disappearing Markers for Daily Radiation Treatment Delivery for Breast Cancer Patients.
ClinicalTrials.gov ID: NCT07095114
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Participant must have histologically or cytologically confirmed stage 0 ductal carcinoma in situ (DCIS), I, II or III breast cancer and be planning...
- 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%
You likely can't join if
- 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...
See the full eligibility 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
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Detroit, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Detroit, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.