No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
Barbara Ann Karmanos Cancer Institute · Other
Who this trial is looking for
This trial is looking for women with certain stages of breast cancer who are going to have radiation treatment. Participants will receive a special tattoo to help with the treatment and take surveys about their body image and the treatment process.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with ductal carcinoma in situ, stage I, II, or III breast cancer.
I am 18 years of age or older.
I can understand and sign an informed consent document.
I was assigned female at birth.
I have a Karnofsky performance score of 70% or higher.
You may not be able to join if
I have had radiation treatment to the affected breast before.
I have a history of allergic reactions to tattoo ink.
I have active chronic skin diseases like psoriasis.
I am pregnant or breastfeeding.
My BMI is greater than 44.5.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 treatmen…
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
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 und…
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.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.