Status:

COMPLETED

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

Lead Sponsor:

Henry Ford Health System

Collaborating Sponsors:

Ephemeral Solutions Inc.

Conditions:

Tattoo; Pigmentation

Cancer, Treatment-Related

Eligibility:

All Genders

18+ years

Phase:

NA

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 ...

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 accurat...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

June 23 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2024

Estimated Enrollment :

15 Patients enrolled

Trial Details

Trial ID

NCT05248009

Start Date

June 23 2022

End Date

September 1 2024

Last Update

November 14 2024

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Henry Ford Health System

Detroit, Michigan, United States, 48202-2689