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

NCT05248009 | Completed

• 1 other identifier: tattoo_schaff2021
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Tattoo; Pigmentation; Cancer, Treatment-Related

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Mean 3D Vector Shifts

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

• Skin Adverse Events - Post Treatment

  Subjects will be followed every 3 months for 15 months after completion of treatment

• Change from Baseline Tattoo Visibility at 15 Months

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

Study Arms (1)

Semi-Permanent Tattoo Ink

EXPERIMENTAL

Semi-Permanent Tattoo Ink

Device: Semi-Permanent Tattoo Ink

Interventions

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.

Semi-Permanent Tattoo Ink

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henry Ford Health System: lead
• Ephemeral Solutions Inc.: collaborator

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202-2689, United States

Location

Related Publications (4)

• 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.

  PMID: 28096199 BACKGROUND

• 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.

  PMID: 20236380 BACKGROUND

• 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.

  PMID: 11316562 BACKGROUND

• 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.

  PMID: 30945803 BACKGROUND

MeSH Terms

Conditions

Neoplasms, Second Primary; Neoplasms

Study Officials

• Farzan Siddiqui, MD PhD

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Staff Physician

Model Details: Single Arm Pilot Trial

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: February 21, 2022
• Study Start: June 23, 2022
• Primary Completion: April 13, 2023
• Study Completion: September 1, 2024
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)