About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Magic Ink
Other interventionA 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
Treatment groups
Trial outcomes
Primary outcomes
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)
Secondary outcomes
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.
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
Sponsors and contacts
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