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PET/MRI in Patients With Suspected Prostate Cancer

NCT02659527 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2023-06-15

No results posted yet for this study

Summary

This diagnostic clinical trial will be conducted according to a randomized, prospective, controlled, double-arm, single-centre design. The control will be implemented by comparing the PET/MRI results with the histopathological finding after radical prostatectomy (positive state), the assumed absence of a relevant prostate cancer focus if PET/MRI guided biopsy and standard biopsy are negative (negative state) and/or the detection of a biochemical tumor relapse \[rising prostate specific antigen (PSA) after PSA nadir; secondary objective\].

Conditions

Interventions

DRUG

68Ga- PSMA-HBED-CC

Patients will receive a dual-tracer PET/MRI scan. FEC and 68Ga-PSMA-HBED-CC, for tissue metabolism and surface marker expressions, as specific PET-tracers as well as multiparametric MRI methods (T2w, DCE, DWI) are used.

DEVICE

Biograph mMR, Siemens

All PET-MRI examinations will be performed using a hybrid PET-MRI system (Biograph mMR, Siemens, Germany) capable of simultaneous data acquisition. The system consists of an MRI-compatible state-of the art PET detector integrated in a 3.0-T whole-body MRI scanner.

Sponsors & Collaborators

  • BSM Diagnostica GmbH Vienna

    collaborator UNKNOWN

  • Siemens Healthcare GmbH

    collaborator UNKNOWN

  • Medical University of Vienna

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2022-05-31
Completion
2022-08-31

Countries

  • Austria

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 NCT02659527 on ClinicalTrials.gov