Feasibility of Semi-Permanent Tattoo for Treatment Alignment in Radiation Therapy

Study Overview
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Brief Summary
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Consenting subjects will receive a semi-permanent tattoo in place of the standard of care permanent tattoo for radiation marking at the time of the radiation planning scan. Subjects will be monitored to ensure alignment is the same with the semi-permanent tattoo as the current standard of care. Subjects will be monitored to ensure there are no skin reactions or other side effects. Subjects will be followed for 15 months and will send pictures to the treatment team to ensure that the tattoo fades away within 12 months as expected.

Detailed Description
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Over 3 million patients are treated each year with radiation therapy, with most of these patients receiving permanent tattoos for treatment alignment. The purpose of these tattoos is to ensure accurate initial patient position prior to treatment. In the case where further on-board imaging such as x-ray or cone-beam CT is used, the radiation tattoos help minimize large shifts which increase treatment time and radiation exposure as further imaging may be required. The tattoos are simple and effective, but also permanent. These permanent tattoos serve as a daily reminder of prior radiation therapy in cancer survivors which may have a negative psychological impact on the patients quality of life. Due to this, many patients will seek laser tattoo removal after completing radiation therapy. There have been attempts at non-permanent tattoo options such as henna as well as omitting tattoos altogether using surface imaging. Unfortunately, henna and other temporary tattoos start to fade quickly and do not last the 6-8 weeks required for longer radiation courses. This means that the tattoos must be reapplied over the course of treatment which can introduce inaccuracies as well as prolongs the treatment time. A novel semi-permanent ink has been developed and recently released which begins to fade after 6 months and disappears after about 1 year. This is the first ink of its kind and is delivered using a needle into the dermis just like a permanent tattoo, however it is able to be resorbed by the body after approximately 1 year. While the original purpose is for cosmetic tattoos it has a possible application in medical tattoos for radiation therapy. It is the goal of this study to show that the semi-permanent ink is safe, allows for accurate alignment of the patient prior to treatment, lasts long enough for a full treatment course, and fades over time. The goal in subsequent studies is to improve patient quality of life by decreasing the negative psychological impact of having permanent tattoos following radiation therapy.

Official Title
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Feasibility of Semi-Permanent Tattoo for Treatment Alignment in Radiation Therapy

Conditions
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Tattoo; Pigmentation, Cancer, Treatment-Related

Intervention / Treatment
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* Device: Semi-Permanent Tattoo Ink


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients requiring medical tattoo for treatment alignment. Patient being treated with some form of image guidance including kV, MV, or cone-beam CT. Age ≥ 18. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Patients will engage in the informed consent process and provide study-specific informed consent prior to study entry and must be willing to have photos taken of their tattoos through the treatment and follow-up process and may be required to take pictures of their own tattoo to submit to the research team. Patient able to send picture of tattoo via secure messaging. Exclusion Criteria: Known allergies or hypersensitivity to tattoo ink. Personal or religious objection to medical tattooing. Autoimmune or skin disorders which may be worsened by medical tattooing. Inability to complete the required forms; however, verbal completion is adequate if recorded on the consent documents.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Single Arm Pilot Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Semi-Permanent Tattoo Ink<br>Semi-Permanent Tattoo Ink | Device: Semi-Permanent Tattoo Ink<br>* Subjects will receive semi-permanent tattoo ink in place of the permanent ink utilized in the standard of care. Subjects will be monitored during their treatment course and for 15 months following treatment completion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin Adverse Events - During Treatment | Adverse events related to the tattooing process including skin toxicity during the completion of radiation therapy will be assessed using Common Terminology Criteria for Adverse Events (CTCAE v5). The type, incidence, severity, timing, serious, and relatedness of AE and laboratory abnormalities will be reported and tabulated. The CTCAE is assessed according to grades 1-5, where grade 5 constitutes the highest severity and worse outcome. | Subjects will be followed weekly during their treatment course | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean 3D Vector Shifts | The primary endpoint is the mean 3D vector shifts as determined by couch shifts from initial setup using tattoo to final treatment position which is verified and shifted based on further imaging including x-ray or cone-beam CT scan. Mean and standard deviation of 3D vector shifts will be summarized, and t-test or Mann-Whitney test will be used to compared with historical data. | Subjects will be followed until completion of their 5-7 week treatment course | 
| Skin Adverse Events - Post Treatment | Adverse events related to the tattooing process including skin toxicity during the completion of radiation therapy will be assessed using Common Terminology Criteria for Adverse Events (CTCAE v5). The type, incidence, severity, timing, serious, and relatedness of AE and laboratory abnormalities will be reported and tabulated. The CTCAE is assessed according to grades 1-5, where grade 5 constitutes the highest severity and worse outcome. | Subjects will be followed every 3 months for 15 months after completion of treatment | 
| Change from Baseline Tattoo Visibility at 15 Months | The second primary endpoint will be tattoo visibility which will be scored on a 4-point scale and assessed until end of follow up. The scoring ranges from 0-3, with 0 representing not visible and 3 representing easily visible. This will be assessed weekly during treatment by both the treating physician/research team as well as the patient. Tattoo fading will be compared to baseline which is measured during the first week of radiation therapy to give time to heal after tattoo placement at time of simulation. Tattoo visibility score from baseline for each patient will be summarized by spaghetti plot. Time to complete invisible will be summarized by Kaplan-Meier method. | Subjects will be followed weekly during their 5-7 week treatment course and every 3 months for 15 months after completion of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radiation therapy, simulation tattoo, cancer, semi-permanent ink