Ductal Carcinoma in SituNCT07095114
A Study of Disappearing Markers for Daily Radiation Treatment Delivery for Breast Cancer Patients.
A study testing Magic Ink in people with Ductal Carcinoma in Situ and Stage I Breast Cancer, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ductal Carcinoma in Situ, Stage I Breast Cancer, Stage II Breast Cancer
- What is being tested?
- Magic Ink
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2025to 8 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 12Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Karmanos Cancer Institute
Detroit, Michigan, 48201
Michael Dominello, DO, 313-576-9546, mdominel@med.wayne.edu
About this study
Official title: A Phase I/II Study of Disappearing Markers for Daily Radiation Treatment Delivery
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.
- Conditions
- Ductal Carcinoma in Situ, Stage I Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer
- Being tested
- Magic Ink
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magic InkOther
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
| Study group | Role | What they receive |
|---|---|---|
| Magic Ink tattoo | Experimental | Magic Ink tattoo ink which is only visible when exposed to ultraviolet light will be used to mark radiation guidance Receives: Other: Magic Ink |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 months after completion of Radiation Therapy
Secondary outcomes (2)
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.
Measured: 3 months after the completion of Radiation Therapy
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
Measured: 3 months after the completion of Radiation Therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start18 Aug 2025
- Primary completion8 Aug 2026 (estimated)
- Study completion8 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ductal Carcinoma in SituStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Dominello, Barbara Ann Karmanos Cancer Institute
- Investigators
- Michael Dominello, DO, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07095114
- Sponsor's protocol ID
- 2025-034
- Status last verified
- Sep 2025
- First submitted
- 15 Jul 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Disappearing Markers for Daily Radiation Treatment Delivery
- ClinicalTrials.gov ID
- NCT07095114
- Acronym / sponsor ID
- 2025-034
- Conditions
- Ductal Carcinoma in Situ, Stage I Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- 8 Aug 2026 (estimated)
- Study completion
- 8 Aug 2026 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magic Ink tattoo | Experimental | Other: Magic InkMagic Ink tattoo ink which is only visible when exposed to ultraviolet light will be used to mark radiation guidance |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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%
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magic InkA 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 | Other | Magic Ink tattoo |
Primary outcome
Safety of Magic Ink
Time frame: 3 months after completion of Radiation Therapy
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)
2 secondary outcomes
Efficacy of Magic Ink
Time frame: 3 months after the completion of Radiation Therapy
Body Image Score
Time frame: 3 months after the completion of Radiation Therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Dominello, DO principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magic Ink in people with Ductal Carcinoma in Situ and Stage I Breast Cancer, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Dominello, DO (3135769546, Mdominel@med.wayne.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Magic Ink (time frame: 3 months after completion of Radiation Therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.