Prostate Cancer Clinical Trial

Serial MRI Scans During Radiation Therapy

Summary

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 pre treatment, during and post standard 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

View Full Description

Full Description

This 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, which means it is the first-time 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
Three MRI scans (Imaging with MRI will be performed as per disease site standards.)
A total of 166 participants will be enrolled in this trial

Phase 1

20 participants in Esophageal Cohort
20 Participants in Glioblastoma Cohort
10 Participants in Prostate Cancer Cohort
10 Participants in Vulvar Cancer Cohort
10 Participants in Pediatric Glioma Cohort

Expansion Cohort

46 Participants in the Glioblastoma Expansion Cohort
50 Participants in the Prostate Cancer Expansion Cohort

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Participants must have a confirmed malignancy requiring radiation therapy.
Age: 18 years or older
ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
Ability to understand and the willingness to sign a written informed consent document.

Any further criteria listed in the specific disease site sub protocol

Patients must be considered appropriate candidates for neoadjuvant chemoradiation therapy followed by esophagectomy
Patients with a histologically confirmed newly diagnosed intracranial glioblastoma or gliosarcoma who will be undergoing radiation therapy as part of clinical care.
Patients with localized prostate caner who are planned to receive androgen deprivation therapy and definitive radiation therapy.
Patients with Biopsy-proven locally advanced vulvar cancer for which definitive radiotherapy is planned
Patients who are age 18 or under (or 18-30 if physician determines that biology is consistent with pediatric high grade glioma) 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.

Exclusion Criteria

Disease-specific exclusion criteria will be specified in a sub protocol.

For MRI involving contrast, history of allergic reactions attributed to gadolinium based IV contrast.

-- Note: If patient will not receive contrast, this is not applicable and kidney function will not affect eligibility

Unable to undergo magnetic resonance imaging (MRI)

Study is for people with:

Prostate Cancer

Estimated Enrollment:

166

Study ID:

NCT04188535

Recruitment Status:

Recruiting

Sponsor:

Dana-Farber Cancer Institute

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There are 2 Locations for this study

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Brigham and Women Hospital
Boston Massachusetts, 02115, United States More Info
Jonathan Leeman, MD
Contact
[email protected]
Jonathan Leeman, MD
Principal Investigator
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States More Info
Jonathan Leeman, MD
Contact
617-732-6452
[email protected]
Jonathan Leeman, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

166

Study ID:

NCT04188535

Recruitment Status:

Recruiting

Sponsor:


Dana-Farber Cancer Institute

How clear is this clinincal trial information?

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