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

• ClinicalTrials.gov Identifier: NCT05248009
• Recruitment Status: Active, not recruiting
• First Posted: February 21, 2022
• Last Update Posted: June 22, 2023
• Sponsor: Henry Ford Health System
• Collaborator: Ephemeral Solutions Inc.
• Information provided by (Responsible Party): Farzan Siddiqui, Henry Ford Health System

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Tattoo; Pigmentation; Cancer, Treatment-Related	Device: Semi-Permanent Tattoo Ink	Not Applicable

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Single Arm Pilot Trial
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Feasibility of Semi-Permanent Tattoo for Treatment Alignment in Radiation Therapy
• Actual Study Start Date: June 23, 2022
• Estimated Primary Completion Date: April 7, 2024
• Estimated Study Completion Date: July 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Semi-Permanent Tattoo Ink; Semi-Permanent Tattoo Ink	Device: Semi-Permanent Tattoo Ink; 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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Michigan

Henry Ford Health System

Detroit, Michigan, United States, 48202-2689

Sponsors and Collaborators

Henry Ford Health System

Ephemeral Solutions Inc.

Investigators

• Principal Investigator: Farzan Siddiqui, MD PhD; Henry Ford Health System

More Information

Publications:

Bryant AK, Banegas MP, Martinez ME, Mell LK, Murphy JD. Trends in Radiation Therapy among Cancer Survivors in the United States, 2000-2030. Cancer Epidemiol Biomarkers Prev. 2017 Jun;26(6):963-970. doi: 10.1158/1055-9965.EPI-16-1023. Epub 2017 Jan 17.

Bregnhoj A, Haedersdal M. Q-switched YAG laser vs. punch biopsy excision for iatrogenic radiation tattoo markers--a randomized controlled trial. J Eur Acad Dermatol Venereol. 2010 Oct;24(10):1183-6. doi: 10.1111/j.1468-3083.2010.03617.x.

Wurstbauer K, Sedlmayer F, Kogelnik HD. Skin markings in external radiotherapy by temporary tattooing with henna: improvement of accuracy and increased patient comfort. Int J Radiat Oncol Biol Phys. 2001 May 1;50(1):179-81. doi: 10.1016/s0360-3016(01)01439-0.

Jimenez RB, Batin E, Giantsoudi D, Hazeltine W, Bertolino K, Ho AY, MacDonald SM, Taghian AG, Gierga DP. Tattoo free setup for partial breast irradiation: A feasibility study. J Appl Clin Med Phys. 2019 Apr;20(4):45-50. doi: 10.1002/acm2.12557.

• Responsible Party: Farzan Siddiqui, Senior Staff Physician, Henry Ford Health System
• ClinicalTrials.gov Identifier: NCT05248009
• Other Study ID Numbers: tattoo_schaff2021
• First Posted: February 21, 2022
• Last Update Posted: June 22, 2023
• Last Verified: June 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Farzan Siddiqui, Henry Ford Health System:

radiation therapy; simulation tattoo; cancer; semi-permanent ink

Additional relevant MeSH terms:

Neoplasms, Second Primary; Neoplasms