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Comparison Study of PET/CT or PET/MRI Imaging to Magnetic Resonance Imaging (MRI) Alone in Men With Prostate Cancer

NCT03439033 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 273

Last updated 2023-03-13

Study results available
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Summary

This is a study primarily comparing Magnetic Resonance Imaging (MRI) alone to Positron Emission Tomography (PET)/MRI using an experimental tracer, 68Ga-PSMA-HBED-CC, among men with prostate cancer or prostatic cancer recurrence/metastasis. It is hypothesized that this comparison will demonstrate that PET using the tracer, 68Ga-PSMA-HBED-CC, is more sensitive than MRI alone. Potential subjects who cannot undergo MRI may undergo PET/CT instead.

Conditions

Interventions

DRUG

PET/MRI with Gallium-68 labeled PSMA-HBED-CC

Subjects have one visit, during which they will undergo one PET/MRI with the study drug, Gallium-68 labeled PSMA-HBED-CC, a radiopharmaceutical

DRUG

Multiple PET/MRI with Gallium-68 labeled PSMA-HBED-CC

Subjects have two visits (the second visit being optional) within two years. During each visit, they will undergo one PET/MRI with the study drug, Gallium-68 labeled PSMA-HBED-CC, a radiopharmaceutical

DRUG

PET/CT with Gallium-68 labeled PSMA-HBED-CC

Subjects have one visit, during which they will undergo one PET/CT with the study drug, Gallium-68 labeled PSMA-HBED-CC, a radiopharmaceutical

Sponsors & Collaborators

  • Cancer Research & Treatment Fund, Inc.

    collaborator INDUSTRY

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Joseph Osborne, M.D., Ph.D. · Weill Medical College of Cornell University

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-03
Primary Completion
2021-05-05
Completion
2021-05-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03439033 on ClinicalTrials.gov