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Serial MRI Scans During Radiation Therapy

RELAY: Repeated Magnetic Resonance Imaging Examinations to Analyze and Assess Your Cancer: A Prospective Study on the Use of Serial Magnetic Resonance Imaging in the Assessment of Changes During Treatment With Radiation Therapy

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "This is a phase 1 study to determine the feasibility and utility of using serial magnetic resonance imaging (MRI) to assess treatment response during and after radiation therapy (standard of care cancer treatment) for participants with advanced esophageal cancer, glioblastoma, prostate cancer, vulvar cancer or pediatric glioma."
  • "The research study procedures include three MRI scans (one before, one during, and one after standard of care cancer radiation therapy) for participants with advanced esophageal cancer, glioblastoma, prostate cancer, vulvar cancer or pediatric glioma."
  • "The research study procedures include: * Screening for eligibility * Three MRI scans"
  • "This is a phase 1, non-randomized, open-label study evaluating feasibility of serial MRI, with an option for an expansion cohort."
  • "This research study is a feasibility study, meaning that it is the first time that investigators at this institution are examining the process of getting multiple MRIs during radiation treatment."
  • "Food and Drug Administration (FDA) has cleared this MRI scanner for use."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This early study tests whether repeated MRI scans are practical and useful for checking how cancer responds to radiation treatment. It includes people with certain cancers of the esophagus (food pipe), brain, prostate, or vulva. Participants have three MRI scans: one before, one during, and one after their usual radiation treatment.

This is a phase 1 study to determine the feasibility and utility of using serial magnetic resonance imaging (MRI) to assess treatment response during and after radiation therapy (standard of care cancer treatment) for participants with advanced esophageal cancer, glioblastoma, prostate cancer, vulvar cancer or pediatric glioma. The research study procedures include three MRI scans (one before, one during, and one after standard of care cancer radiation therapy) for participants with advanced esophageal cancer, glioblastoma, prostate cancer, vulvar cancer or pediatric glioma. The research study procedures include: * Screening for eligibility * Three MRI scans

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have confirmed cancer that needs radiation treatment. Usually, you must be at least 18, but some study groups allow younger people. You must also meet any extra rules for your cancer group.
  • Be able to do at least some daily activities and personal care. You must understand the study and agree in writing; for the pediatric group, a parent or legal representative may give consent.
  • Esophagus cancer group: Be able to receive chemotherapy and radiation before surgery to remove the esophagus. Have an ultrasound test from inside the food pipe done or scheduled by the first visit.
  • Glioblastoma group: Have newly diagnosed glioblastoma or gliosarcoma, types of brain cancer, confirmed by a tissue test. Plan to receive radiation as part of usual care.
  • Prostate cancer group: Have cancer that has not spread beyond the prostate area. Plan to receive hormone-lowering treatment and radiation to treat the cancer.
  • Vulvar cancer group: Have cancer of the outer female genitals that has grown into nearby areas, confirmed by a tissue sample. Plan to receive radiation to treat it.
  • Pediatric glioma group: Have newly diagnosed grade III or IV glioma, a fast-growing brain tumor, confirmed by a tissue test, and plan to receive radiation. Be 18 or younger; ages 18–30 may qualify if a doctor finds that the tumor’s genes fit a childhood-type glioma. A brain tumor called DIPG must be confirmed as high-grade by a tissue sample.
  • Sarcoma group: The listing says this group requires newly diagnosed grade III or IV glioma, a fast-growing brain tumor, confirmed by a tissue test, with radiation planned as part of usual care.

Who can't join

  • Cannot have an MRI scan.
  • Have had an allergic reaction to gadolinium, a dye given through a vein for some MRI scans, if dye will be used. If no dye is used, this allergy and kidney function do not affect eligibility.
  • Other reasons you cannot join may apply to your cancer group.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Participants must have a confirmed malignancy requiring radiation therapy. * Age: 18 years or older except where otherwise specified in subprotocol. * ECOG performance status ≤2 (Karnofsky ≥60%) * Ability to understand and the willingness to sign a written informed consent document. * Any further criteria listed in the specific disease site subprotocol. * (Esophageal cohort) Patients must be considered appropriate candidates for neoadjuvant chemoradiation therapy followed by esophagectomy. Patients must have an endoscopic ultrasound done or scheduled to be done at the baseline visit. * (Glioblastoma cohort) Patients with a histologically confirmed newly diagnosed intracranial glioblastoma or gliosarcoma who will be undergoing radiation therapy as part of clinical care. * (Prostate cohort) Patients with localized prostate cancer who are planning to receive androgen deprivation therapy and definitive radiation therapy. * (Vulvar cohort) Patients with biopsy-proven locally advanced vulvar cancer for which definitive radiotherapy is planned. * (Pediatric glioma cohort) Patients age 18 or under (patients 18-30 years old are also eligible if the physician determines that based on genetics, the tumor biology is consistent with pediatric high grade glioma). Patients with a histologically confirmed newly diagnosed high-grade glioma (WHO grade III or IV) who will be undergoing radiation therapy as part of clinical care. Patients with DIPG are only eligible if biopsy-confirmed high grade DIPG is present. Ability to understand and/or willingness of their parent or legally authorized representative to sign a written informed consent document. * (Sarcoma cohort) Patients with a histologically confirmed newly diagnosed high-grade glioma (WHO grade III or IV) who will be undergoing radiation therapy as part of clinical care. Exclusion Criteria: * Disease-specific exclusion criteria will be specified in a subprotocol. * For MRI involving contrast, history of allergic reactions attributed to gadolinium-based IV contrast. If patient will not receive contrast, this is not applicable and kidney function will not affect eligibility. * Inability to undergo magnetic resonance imaging (MRI).

Study sites (2)

MA