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Serial MRI Scans During Radiation Therapy

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

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).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04188535
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Dana-Farber Cancer Institute
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Jonathan Leeman, MD
Principal Investigator Affiliation Dana-Farber Cancer Institute
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma, Esophageal Cancer, Radiotherapy, Magnetic Resonance Imaging, MRI, Prostate Cancer, Vulvar Cancer, Pediatric Glioblastoma Multiforme
Additional Details

This is a phase 1, non-randomized, open-label study evaluating feasibility of serial MRI, with an option for an expansion cohort. The optional expansion cohort is a prospective imaging registry evaluating imaging biomarkers as predictors of disease control with standard of care treatment. 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. The U.S. Food and Drug Administration (FDA) has cleared this MRI scanner for use. Participants who fulfill eligibility criteria will be entered into the trial. The research study procedures include screening for eligibility, and three MRI scans. MRI imaging will be performed as per disease site standards. A total of 139 participants will be enrolled in this trial:

  • - 13 participants in the esophageal cancer cohort.
  • - 10 participants in the initial glioblastoma cohort and 36 participants in the image registry expansion cohort.
  • - 10 participants in the prostate cancer cohort and 50 participants in the image registry expansion cohort.
  • - 10 participants in the vulvar cancer cohort.
- 10 participants in the pediatric glioma cohort

Arms & Interventions

Arms

Experimental: Esophageal Cohort

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.

Experimental: Glioblastoma Cohort

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.

Experimental: Glioblastoma Expansion Cohort Serial MR Imaging Registry

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.

Experimental: Prostate Cancer Cohort

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

Experimental: Prostate Cancer Expansion Cohort Serial MR Imaging Registry

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

Experimental: Vulvar Cancer Cohort

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.

Experimental: Pediatric Glioma Cohort

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.

Interventions

Diagnostic Test: - MRI IMAGING

Imaging with MRI will be performed as per disease site standards.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Brigham and Women Hospital, Boston, Massachusetts

Status

Recruiting

Address

Brigham and Women Hospital

Boston, Massachusetts, 02115

Site Contact

Jonathan Leeman, MD

JONATHANE_LEEMAN@DFCI.HARVARD.EDU

(617) 732-6452

Dana Farber Cancer Institute, Boston, Massachusetts

Status

Recruiting

Address

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

Site Contact

Jonathan Leeman, MD

JONATHANE_LEEMAN@DFCI.HARVARD.EDU

617-732-6452

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