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Completed

NCT Number: NCT05248009

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henry Ford Health System

Detroit, Michigan, 48202-2689, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Semi-Permanent Tattoo Ink

Device

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.

Primary outcomes

  1. Skin Adverse Events - During Treatment

    Time frame: Subjects will be followed weekly during their treatment course

    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.

Secondary outcomes

  1. Mean 3D Vector Shifts

    Time frame: Subjects will be followed until completion of their 5-7 week treatment course

    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.

  2. Skin Adverse Events - Post Treatment

    Time frame: Subjects will be followed every 3 months for 15 months after completion of 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.

  3. Change from Baseline Tattoo Visibility at 15 Months

    Time frame: Subjects will be followed weekly during their 5-7 week treatment course and every 3 months for 15 months after completion of treatment

    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.

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Collaborators

  • Ephemeral Solutions Inc.

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Feb 21, 2022
Registry last updated
Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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