RECRUITING

Serial MRI Scans During Radiation Therapy

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Conditions

GlioblastomaEsophageal CancerRadiotherapyMagnetic Resonance ImagingMRIProstate CancerVulvar CancerPediatric Glioblastoma Multiforme

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2020-01-15
Study Completion:2025-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04188535

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants must have a confirmed malignancy requiring radiation therapy.
  2. * Age: 18 years or older except where otherwise specified in subprotocol.
  3. * ECOG performance status ≤2 (Karnofsky ≥60%)
  4. * Ability to understand and the willingness to sign a written informed consent document.
  5. * Any further criteria listed in the specific disease site subprotocol.
  6. * (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.
  7. * (Glioblastoma cohort) Patients with a histologically confirmed newly diagnosed intracranial glioblastoma or gliosarcoma who will be undergoing radiation therapy as part of clinical care.
  8. * (Prostate cohort) Patients with localized prostate cancer who are planning to receive androgen deprivation therapy and definitive radiation therapy.
  9. * (Vulvar cohort) Patients with biopsy-proven locally advanced vulvar cancer for which definitive radiotherapy is planned.
  10. * (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.
  1. * Disease-specific exclusion criteria will be specified in a subprotocol.
  2. * 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.
  3. * Inability to undergo magnetic resonance imaging (MRI).

Contacts and Locations

Study Contact

Jonathan Leeman, MD
CONTACT
(617) 732-6452
JONATHANE_LEEMAN@DFCI.HARVARD.EDU

Principal Investigator

Jonathan Leeman, MD
PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute

Study Locations (Sites)

Brigham and Women Hospital
Boston, Massachusetts, 02115
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States

Collaborators and Investigators

Sponsor: Dana-Farber Cancer Institute

  • Jonathan Leeman, MD, PRINCIPAL_INVESTIGATOR, Dana-Farber Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-01-15
Study Completion Date2025-07-31

Study Record Updates

Study Start Date2020-01-15
Study Completion Date2025-07-31

Terms related to this study

Keywords Provided by Researchers

  • Glioblastoma
  • Esophageal Cancer
  • Radiotherapy
  • Magnetic Resonance Imaging
  • MRI
  • Prostate Cancer
  • Vulvar Cancer
  • Pediatric Glioblastoma Multiforme

Additional Relevant MeSH Terms

  • Glioblastoma
  • Esophageal Cancer
  • Radiotherapy
  • Magnetic Resonance Imaging
  • MRI
  • Prostate Cancer
  • Vulvar Cancer
  • Pediatric Glioblastoma Multiforme