Study Summary
This trial is testing whether a semi-permanent tattoo is a better alternative to the current standard of care permanent tattoo for radiation marking.
Eligible Conditions
- Tattoo
- Treatment-Related Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 3 Secondary · Reporting Duration: Subjects will be followed weekly during their 5-7 week treatment course and every 3 months for 15 months after completion of treatment
Month 15
Skin Adverse Events - Post Treatment
Week 7
Mean 3D Vector Shifts
Week 7
Skin Adverse Events - During Treatment
Month 15
Change from Baseline Tattoo Visibility at 15 Months
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Semi-Permanent Tattoo Ink
1 of 1
Experimental Treatment
20 Total Participants · 1 Treatment Group
Primary Treatment: Semi-Permanent Tattoo Ink · No Placebo Group · N/A
Semi-Permanent Tattoo Ink
Device
Experimental Group · 1 Intervention: Semi-Permanent Tattoo Ink · Intervention Types: DeviceTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: subjects will be followed weekly during their 5-7 week treatment course and every 3 months for 15 months after completion of treatment
Who is running the clinical trial?
Henry Ford Health SystemLead Sponsor
264 Previous Clinical Trials
2,012,102 Total Patients Enrolled
Ephemeral Solutions Inc.UNKNOWN
Farzan Siddiqui, MD PhDPrincipal InvestigatorHenry Ford Health System
1 Previous Clinical Trials
65 Total Patients Enrolled
Eric Schaff, MDPrincipal InvestigatorHenry Ford Health System
Eligibility Criteria
Age 18+ · All Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are being treated for solid tumors with planned treatment lasting at least 5 weeks.
You have a performance status of 0-2.
References
- Bryant, Alex K., Matthew P. Banegas, Maria Elena Martinez, Loren K. Mell, and James D. Murphy. 2017. “Trends in Radiation Therapy Among Cancer Survivors in the United States, 2000–2030”. Cancer Epidemiology, Biomarkers & Prevention. American Association for Cancer Research (AACR). doi:10.1158/1055-9965.epi-16-1023.
- Jimenez, Rachel B., Estelle Batin, Drosoula Giantsoudi, William Hazeltine, Kendell Bertolino, Alice Y. Ho, Shannon M. MacDonald, Alphonse G. Taghian, and David P. Gierga. 2019. “Tattoo Free Setup for Partial Breast Irradiation: A Feasibility Study”. Journal of Applied Clinical Medical Physics. Wiley. doi:10.1002/acm2.12557.
- Bregnhøj, A, and M Haedersdal. 2010. “Q-switched YAG Laser Vs. Punch Biopsy Excision for Iatrogenic Radiation Tattoo Markers - a Randomized Controlled Trial”. Journal of the European Academy of Dermatology and Venereology. Wiley. doi:10.1111/j.1468-3083.2010.03617.x.
- Wurstbauer, Karl, Felix Sedlmayer, and H.Dieter Kogelnik. 2001. “Skin Markings in External Radiotherapy by Temporary Tattooing with Henna: Improvement of Accuracy and Increased Patient Comfort”. International Journal of Radiation Oncology*biology*physics. Elsevier BV. doi:10.1016/s0360-3016(01)01439-0.
- 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.
- Farzan Siddiqui 2022. "Feasibility of Semi-Permanent Tattoo for Treatment Alignment in Radiation Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05248009.
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Conditions
Cancer Related
Treatments