Serial MRI Scans During Radiation Therapy (RELAY)

Dana-Farber Cancer Institute

Status: Enrolling

Conditions: MRI; Glioblastoma; Vulvar Cancer; Esophageal Cancer; Radiotherapy; Pediatric Glioblastoma Multiforme; Prostate Cancer; Magnetic Resonance Imaging

Treatments: Diagnostic Test: MRI IMAGING

Study type: Interventional

Funder types: Other

Identifiers

NCT04188535

19-573

Details and patient eligibility

About

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

Full description

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 149 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
• 10 participants in the sarcoma cohort

Enrollment: 149 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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149 participants in 8 patient groups

Esophageal Cohort

Experimental group

Description:

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.

Treatment:

Diagnostic Test: MRI IMAGING

Glioblastoma Cohort

Experimental group

Description:

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.

Treatment:

Diagnostic Test: MRI IMAGING

Glioblastoma Expansion Cohort Serial MR Imaging Registry

Experimental group

Description:

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.

Treatment:

Diagnostic Test: MRI IMAGING

Prostate Cancer Cohort

Experimental group

Description:

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

Treatment:

Diagnostic Test: MRI IMAGING

Prostate Cancer Expansion Cohort Serial MR Imaging Registry

Experimental group

Description:

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

Treatment:

Diagnostic Test: MRI IMAGING

Vulvar Cancer Cohort

Experimental group

Description:

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.

Treatment:

Diagnostic Test: MRI IMAGING

Pediatric Glioma Cohort

Experimental group

Description:

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.

Treatment:

Diagnostic Test: MRI IMAGING

Sarcoma Cohort

Experimental group

Description:

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.

Treatment:

Diagnostic Test: MRI IMAGING