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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
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
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.
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.Check my eligibility
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.See study design
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.
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I am undergoing treatment that involves guided imaging techniques.
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I can take care of myself and am up and about more than half of my waking hours.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Skin Adverse Events - During Treatment
Secondary outcome measures
Change from Baseline Tattoo Visibility at 15 Months
Mean 3D Vector Shifts
Skin Adverse Events - Post Treatment
Trial Design
1Treatment groups
Experimental Treatment
Group I: Semi-Permanent Tattoo InkExperimental Treatment1 Intervention
Semi-Permanent Tattoo Ink
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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
300 Previous Clinical Trials
2,099,984 Total Patients Enrolled
Farzan Siddiqui, MD PhDPrincipal InvestigatorHenry Ford Health System
1 Previous Clinical Trials
65 Total Patients Enrolled
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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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are currently partaking in this trial?
"Affirmative. Clinicaltrials.gov confirms that the study, which was posted on June 23rd 2022 is still actively recruiting patients. The research team needs to find 20 volunteers at a single medical centre."
Answered by AI
Are any participants being accepted for this experiment?
"Per the details on clinicaltrials.gov, this investigation is currently recruiting volunteers and has been since June 23rd 2022. The most recent update was made on July 20th of the same year."
Answered by AI
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