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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magic Ink tattoo | Experimental | Magic Ink tattoo ink which is only visible when exposed to ultraviolet light will be used to mark radiation guidance |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magic Ink | Other | 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 |
| 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 |
| 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 |
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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:
For the first six participants only: Participant must have a Fitzpatrick Skin Tone Scale of 5 or 6
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Dominello, DO | Contact | 3135769546 | Mdominel@med.wayne.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michael Dominello, DO | Wayne State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karmanos Cancer Institute | Recruiting | Detroit | Michigan | 48201 | United States |
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| ID | Term |
|---|---|
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| 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 |
| D009369 | Neoplasms |
| D000071960 | Breast Carcinoma In Situ |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |