What side effects are associated with this type of intervention?

Common treatments for cancer, such as radiation therapy and chemotherapy, have several known side effects. Radiation therapy can cause skin reactions, fatigue, and localized pain or discomfort. Chemotherapy often leads to side effects like alopecia (hair loss), nausea, vomiting, fatigue, and increased susceptibility to infections. Specific to the use of semi-permanent tattoos for radiation alignment, there are no significant additional side effects reported beyond those associated with standard radiation therapy.

What prior FDA approvals exist?

The FDA has approved various innovative treatments for cancer, including immunotherapies like ipilimumab and pembrolizumab for melanoma, and sipuleucel-T for prostate cancer. These treatments focus on enhancing the body's immune response to target cancer cells. While the semi-permanent tattoo for radiation alignment is a novel supportive care method under investigation, it is not directly comparable to these FDA-approved therapies. The semi-permanent tattoo aims to improve patient experience and precision in radiation therapy, a crucial aspect of cancer treatment.

What other types of research exist?

Promising alternatives to semi-permanent tattoos for radiation alignment in cancer patients include: 1) Fiducial markers, which are small objects placed in or near the tumor to guide precise radiation delivery. 2) Image-guided radiotherapy (IGRT), which uses imaging techniques to improve the accuracy of radiation treatment. 3) Surface-guided radiotherapy (SGRT), which employs 3D surface imaging to track patient positioning in real-time. These methods enhance precision and patient comfort while minimizing skin reactions.

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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 below

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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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and subjects will be followed every 3 months for 15 months after completion of treatment for reporting.

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

0 / 4Eligibility criteria met

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.

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.