Repeated Magnetic Resonance Imaging Scans for the Analysis of Cancer Response during Radiation Therapy, the RELAY Trial

PRIMARY OBJECTIVES:

I. To determine feasibility of acquiring serial MRI scans on an MRI simulator during treatment with radiation therapy. (Phase I)

II. To measure disease control, defined by the subprotocol. (Imaging Registration Expansion Cohort)

III. To determine feasibility of acquiring serial MRI scans on an MRI simulator during treatment of

locally advanced esophageal cancer with preoperative chemoradiation. (Esophageal Cohort)

IV. To determine feasibility of acquiring serial MRI scans on an MRI simulator during treatment of glioblastoma with radiation therapy. (Glioblastoma Cohort)

V. To determine feasibility of acquiring serial MRI scans on an MRI simulator during treatment of prostate cancer with androgen deprivation therapy and radiation therapy. (Prostate Cohort)

VI. To determine the feasibility of serial MR acquisition on an MR simulator before, during, and after treatment of vulvar cancer with radiation therapy. (Vulvar Cohort)

VII. To determine feasibility of acquiring serial MRI scans on an MRI simulator during treatment of pediatric high-grade gliomas with radiation therapy. (Pediatric High-Grade Glioma Cohort)

VIII. To determine feasibility of acquiring serial MRI scans on an MRI simulator during treatment of extremity/trunk soft tissue sarcomas with radiation therapy. (Soft Tissue Sarcoma Cohort)

SECONDARY OBJECTIVES:

I. For subprotocols studying the adaptive treatment, dosimetric change in the in silico adaptive radiation therapy plans, without delivering adaptive plans in Phase I. (Phase I)

II. Determining the correlation between baseline T and N stage as assessed by endoscopic ultrasound with baseline T and N stage as assessed by MRI. (Esophageal Cohort)

III. Determining the correlation between T stage derived from MRI data and T stage derived from pathologic data. (Esophageal Cohort)

IV. Determining if the apparent diffusion coefficient, measured from diffusion-weighted MRI data, correlates with pathologic response. (Esophageal Cohort)

V. To validate a predictive model to identify the most likely area of recurrence using MRI-based features in patients for newly diagnosed glioblastoma (GBM) patients undergoing radiation therapy. (Glioblastoma Cohort)

VI. To evaluate the use of early imaging-based biomarkers to predict clinically relevant outcomes in GBM in a prospective cohort including treatment response assessment (including pseudoprogression), treatment toxicity, radiographic response, progression-free survival and overall survival. (Glioblastoma Cohort)

VII. To determine correlation between changes in diffusion weighted imaging and changes in PSA in response to neoadjuvant androgen deprivation therapy. (Prostate Cohort)

VIII. To determine correlation between changes in diffusion weighted imaging and post-treatment changes in PSA in response to radiation therapy. (Prostate Cohort)

IX. To determine the correlation between Decipher test results and response to therapy, with the goal of identifying a genetic predictor of response. (Prostate Cohort)

X. To preliminarily evaluate the impact of MR imaging on radiotherapy boost planning, including target and normal tissue delineation. (Vulvar Cohort)

XI. To preliminarily evaluate determine the association between changes in tumor measurements from MRI data and response to radiation therapy (including local control and patient-reported outcomes). (Vulvar Cohort)

XII. To determine the association between changes in tumor measurements from MRI data and response to radiation (including progression-free survival, overall survival, and radiographic response). (Pediatric High-Grade Glioma Cohort)

XIII. To determine the association between changes in tumor measurements from MRI data and treatment toxicity and/or pseudoprogression. (Pediatric High-Grade Glioma Cohort)

XIV. To evaluate tumor volume changes during radiation treatment and determine whether these changes necessitate re-simulation and re-planning. (Soft Tissue Sarcoma Cohort)

XV. To evaluate the association between the apparent diffusion coefficient (ADC) derived from diffusion-weighted MRI and tumor’s response to irradiation. (Soft Tissue Sarcoma Cohort)

XVI. To investigate variations of tumor perfusion in response to irradiation using dynamic contrast enhanced (DCE) MRI. (Soft Tissue Sarcoma Cohort)

EXPLORATORY OBJECTIVES:

I. To investigate radiographic and biologic biomarkers predictive of response to radiation.

II. To evaluate cost-effectiveness, operational efficiency, and patient satisfaction with MR simulation.

III. To evaluate whether MRI-based features during treatment can predict areas of recurrence in pediatric patients with newly diagnosed high-grade glioma undergoing radiation therapy. (Pediatric High-Grade Glioma Cohort)

OUTLINE:

PHASE I: Patients undergo MRI prior to start of standard of care radiation treatment, midway through treatment, and after treatment.

IMAGING REGISTRY EXPANSION COHORTS: Patients are assigned to an expansion cohort based on cancer type.

ESOPHAGEAL COHORT: Patients undergo MRI prior to start of standard of care radiation treatment, after 2 weeks of treatment, and 2-4 weeks after end of treatment. Patients undergo computed tomography (CT) scan at baseline.

GLIOBLASTOMA COHORT: Patients undergo MRI prior to start of standard of care radiation treatment, during the 3rd or 4th week of treatment, and 3-6 weeks after end of treatment. Patients undergo CT scan at baseline.

PROSTATE COHORT: Patients undergo MRI at baseline, and at 2 and 6 months after initiation of neoadjuvant androgen deprivation therapy. Patients undergo CT scan at baseline and blood sample collection throughout the study.

VULVAR COHORT: Patients undergo MRI at baseline, 1-2 weeks before initiation of radiotherapy boost (week 3-4 from initiation of radiation), and 1-4 months after completion of radiation therapy. Patients undergo CT scan at baseline.

PEDIATRIC HIGH-GRADE GLIOMA COHORT: Patients undergo MRI at baseline, at 3-4 week of radiation therapy, and last week of radiation therapy-8 weeks after radiation therapy. Patients undergo CT scan at baseline and blood sample collection throughout the study.

SOFT TISSUE SARCOMA COHORT: Patients undergo MRI at baseline, 3 weeks and 3-8 weeks post radiation. Patients undergo CT scan at baseline and cone beam CT scan throughout the study.