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Completed

NCT Number: NCT03809078

68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for Biopsy Guidance in Patients With Suspected Prostate Cancer

The objective of the study is to evaluate 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for biopsy guidance in patients with suspected prostate cancer.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Stanford University

Stanford, California, 94305, United States

About this study

Primary Objective: To evaluate 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for biopsy guidance in patients with suspected prostate cancer.

Exploratory Objective:

  • Correlation of 68Ga PSMA 11 uptake and Gleason score at biopsy
  • Correlation of 68Ga RM2 and Gleason score at biopsy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Suspected prostate cancer
  • Planned prostate biopsy
  • Able to provide written consent
  • Karnofsky performance status of 50 (or ECOG/WHO equivalent)

Exclusion criteria

  • Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam
  • Metallic implants (contraindicated for MRI)

Treatment and study plan

68Ga RM2

Drug

PET radiopharmaceutical

Other names: 68Ga DOTA Bombesin, BAY86 7548

68Ga-PSMA-11

Drug

PET radiopharmaceutical

Other names: DFKZ 11, HBED CC PSMA, Heidelberg compound

Investigational PET scanner coils and software

Device

GE Healthcare non-approved PET scanner coils and software

Primary outcomes

  1. Number of Participants With Biopsy Results Correlated With PET Based Imaging Findings

    Time frame: Up to approximately 2 hours to complete each scan

    Measure of PET based Biopsy Guidance (ie, prostate uptake on 68Ga PSMA 11 and 68Ga RM2 scans).

Sponsors and collaborators

Lead sponsor

Andrei Iagaru

Other

Collaborators

  • General Electric

Registry information

Official study title

A Pilot Study of 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for Biopsy Guidance in Patients With Suspected Prostate Cancer

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jan 18, 2019
Registry last updated
Jan 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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