drugset / Trial / NCT04266392

Molecular Imaging of Prostate Cancer Using Radiofluorinated PSMA Ligand

NCT04266392

NaSingle-groupOpen-labelDiagnostic

Summary

Eligible patients have prostate cancer that was treated with surgery or radiation therapy for localized disease and there is evidence of biochemical recurrence and/or metastases on conventional imaging.The objective of this study is to assess the performance in detection of prostate cancer of a new positron emission tomography (PET) radiotracer for prostate cancer (\[18F\]-DCFPyl) combined with magnetic resonance imaging (MRI). Results of tracer uptake and MRI image features as whole body PET/MRI and dedicated pelvic/prostate PET/MRI, alone and together, will be correlated and compared to detection of lesions on conventional imaging modalities. Additionally, if the patient undergoes a biopsy as standard of care, image features will correlate directly with histopathological findings.Validation of this radiotracer can potentially lead to its use as a standard of care for future imaging and improve diagnosis and treatment guidance.This drug is not approved by the Food and Drug Administration (FDA) and is therefore considered experimental.There will be 20 subjects enrolled in this study; all of these patients will be enrolled at Stony Brook University Medical Center.

Timeline

Start
2019-12-16
Primary completion
2021-10-15
Completion
2021-10-15

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject 18F-DCFPyL Diagnostic / imaging agent

Indications