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Semi-Permanent Tattooing for Radiation Therapy Alignment in Cancer Patients
N/A
Waitlist Available
Led By Farzan Siddiqui, MD PhD
Research Sponsored by Henry Ford Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18
Patient being treated with some form of image guidance including kV, MV, or cone-beam CT
Must not have
Personal or religious objection to medical tattooing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up subjects will be followed weekly during their 5-7 week treatment course and every 3 months for 15 months after completion of treatment
Awards & highlights
No Placebo-Only Group
Summary
This trial uses a semi-permanent tattoo for patients undergoing radiation therapy. The tattoo lasts long enough for the treatment period but fades away over time, aiming to reduce the negative psychological impact of permanent tattoos. Tattooing has been used in the field of medicine for purposes such as radiotherapy field marking.
Who is the study for?
This trial is for adults (18+) who need a medical tattoo for cancer treatment alignment and can send pictures of the tattoo to the research team. They should have an ECOG performance status of 0-2, indicating they are fully active or at least ambulatory and capable of all self-care. Participants must not have allergies to tattoo ink, autoimmune or skin disorders that could worsen with tattooing, or objections to medical tattooing.
What is being tested?
The study tests if a semi-permanent tattoo can be used instead of a permanent one for aligning radiation therapy in cancer patients. The feasibility, accuracy of alignment compared to standard tattoos, potential skin reactions, and whether the semi-permanent version fades within 12 months will be monitored.
What are the potential side effects?
Potential side effects include skin reactions related to the semi-permanent ink used for the tattoos. These may vary from minor irritation to allergic responses depending on individual sensitivity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am undergoing treatment that involves guided imaging techniques.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I object to medical tattooing due to personal or religious reasons.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ subjects will be followed every 3 months for 15 months after completion of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~subjects will be followed every 3 months for 15 months after completion of treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Skin Adverse Events - During Treatment
Secondary study objectives
Change from Baseline Tattoo Visibility at 15 Months
Mean 3D Vector Shifts
Skin Adverse Events - Post Treatment
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Semi-Permanent Tattoo InkExperimental Treatment1 Intervention
Semi-Permanent Tattoo Ink
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Radiation therapy, a common cancer treatment, works by damaging the DNA of cancer cells, preventing them from replicating and causing cell death. Accurate targeting is essential to maximize the treatment's effectiveness and minimize harm to healthy tissue.
Semi-permanent tattoos are used to ensure precise and consistent alignment during each radiation session, which is crucial for both the efficacy and safety of the therapy.
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Comparative Effectiveness Analyses of Salvage Prostatectomy and Salvage Radiotherapy Outcomes Following Focal or Whole-Gland Ablative Therapy (High-Intensity Focused Ultrasound, Cryotherapy or Electroporation) for Localised Prostate Cancer.Treatment of cancer with radiation and drugs.Pain Response After Stereotactic Body Radiation Therapy Versus Conventional Radiation Therapy in Patients With Bone Metastases-A Phase 2 Randomized Controlled Trial Within a Prospective Cohort.
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Who is running the clinical trial?
Ephemeral Solutions Inc.Industry Sponsor
1 Previous Clinical Trials
45 Total Patients Enrolled
Henry Ford Health SystemLead Sponsor
310 Previous Clinical Trials
2,168,994 Total Patients Enrolled
Farzan Siddiqui, MD PhDPrincipal InvestigatorHenry Ford Health System
1 Previous Clinical Trials
65 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am undergoing treatment that involves guided imaging techniques.I can take care of myself and am up and about more than half of my waking hours.I object to medical tattooing due to personal or religious reasons.I have a condition that could get worse with medical tattooing.
Research Study Groups:
This trial has the following groups:- Group 1: Semi-Permanent Tattoo Ink
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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