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MRI Scans During Radiation Therapy for Cancer (RELAY Trial)

N/A

Recruiting

Led By Jonathan Leeman, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)

Participants must have a confirmed malignancy requiring radiation therapy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is to study if using MRIs to track response to radiation therapy is feasible and useful for patients with certain types of cancer.

Who is the study for?

This trial is for adults with advanced esophageal cancer, glioblastoma, prostate cancer, vulvar cancer or pediatric high-grade glioma who need radiation therapy. They must be in a condition to understand and sign consent. Exclusions include allergies to MRI contrast (unless not using contrast) and inability to undergo MRI.

What is being tested?

The study tests the use of serial MRIs—before, during, and after standard radiation therapy—to monitor treatment response in patients with certain advanced cancers. It's a phase 1 trial focused on feasibility and utility of this imaging technique during treatment.

What are the potential side effects?

There are generally no side effects associated directly with undergoing an MRI scan itself; however, if contrast is used there's a small risk of allergic reaction for those sensitive to gadolinium-based contrasts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself but might not be able to do heavy physical work.

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My cancer needs radiation treatment.

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I have localized prostate cancer and will get hormone therapy and radiation.

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I have a new diagnosis of glioblastoma or gliosarcoma and will be receiving radiation therapy.

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I have advanced vulvar cancer and will undergo definitive radiotherapy.

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I am 18 years old or older.

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I am a suitable candidate for chemotherapy and radiation before esophagus surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Ability to measure disease control (for imaging registry expansion cohort)

Feasibility of acquiring serial MRI scans on an MRI simulator during treatment with radiation therapy

Secondary study objectives

Dosimetric change

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

7Treatment groups

Experimental Treatment

Group I: Vulvar Cancer CohortExperimental Treatment1 Intervention

The research study procedures include: * Screening for eligibility * Three MRI scans prior to start of standard cancer treatment, in the middle, and at the end of radiation treatment). Imaging with MRI will be performed as per disease site standards.

Group II: Prostate Cancer Expansion Cohort Serial MR Imaging RegistryExperimental Treatment1 Intervention

The research study procedures include: * Screening for eligibility * Three MRI scans prior to start of androgen deprivation therapy, prior to the start of radiation treatment, and after radiation treatment). Imaging with MRI will be performed as per disease site standards. * Genomic testing of biopsy sample

Group III: Prostate Cancer CohortExperimental Treatment1 Intervention

Group IV: Pediatric Glioma CohortExperimental Treatment1 Intervention

Group V: Glioblastoma Expansion Cohort Serial MR Imaging RegistryExperimental Treatment1 Intervention

Group VI: Glioblastoma CohortExperimental Treatment1 Intervention

Group VII: Esophageal CohortExperimental Treatment1 Intervention

The research study procedures include: * Screening for eligibility * Three MRI scans (prior to start of standard cancer treatment, in the middle, and at the end of radiation treatment). Imaging with MRI will be performed as per disease site standards.

0 / 7Eligibility criteria met