Serial MRI Scans During Radiation Therapy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDana-Farber Cancer Institute

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Design model

Sequential

Treatments tested in this trial

  • MRI IMAGING

    Diagnostic test

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

Treatment groups

149 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Esophageal CohortExperimental treatment 1 intervention
Group B: Glioblastoma CohortExperimental treatment 1 intervention
Group C: Glioblastoma Expansion Cohort Serial MR Imaging RegistryExperimental treatment 1 intervention
Group D: Prostate Cancer CohortExperimental treatment 1 intervention
Group E: Prostate Cancer Expansion Cohort Serial MR Imaging RegistryExperimental treatment 1 intervention
Group F: Vulvar Cancer CohortExperimental treatment 1 intervention
Group G: Pediatric Glioma CohortExperimental treatment 1 intervention
Group H: Sarcoma CohortExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility of acquiring serial MRI scans on an MRI simulator during treatment with radiation therapy

90% lower confidence limit (LCL) on the true feasibility rate. Feasibility is defined as successfully enrolling patients, acquiring MRI data at all timepoints, identifying the target on MRI data obtained at all timepoints, and processing MRI data at all timepoints to yield pre-specified MRI-derived measurements.

Time frame
1 year
2

Ability to measure disease control (for imaging registry expansion cohort)

Validating a previously developed predictive model to identify the most likely area of recurrence using MRI-based features.

Time frame
2 years

Secondary outcomes

1

Dosimetric change

For subprotocols studying the adaptive treatment, the secondary objective is dosimetric change in the in silico adaptive radiation therapy plans, without delivering adaptive plans in Phase I.

Time frame
1 year

Other outcomes

Sponsors and contacts

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