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

Sponsor
Andrei Iagaru (Other)
Overall Status
Suspended
CT.gov ID
NCT03809078
Collaborator
General Electric (Industry)
20
Enrollment
1
Location
2
Arms
60.6
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: 68Ga RM2
  • Drug: 68Ga-PSMA-11
  • Device: Investigational PET scanner coils and software
 Phase 2

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
A Pilot Study of 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for Biopsy Guidance in Patients With Suspected Prostate Cancer
Actual Study Start Date :
Jan 14, 2019
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 68Ga RM2 first followed by 68Ga PSMA11

Participant will be injected IV with 140 ±20% mBq of 68Ga RM2 and then within two weeks Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA11

Drug: 68Ga RM2
PET radiopharmaceutical
Other Names:
  • 68Ga DOTA Bombesin
  • BAY86 7548

    • Drug: 68Ga-PSMA-11
    PET radiopharmaceutical
    Other Names:
  • DFKZ 11
  • HBED CC PSMA
  • Heidelberg compound

    • Device: Investigational PET scanner coils and software
    GE Healthcare non-approved PET scanner coils and software
    Experimental: 68Ga PSMA11 first followed by 68Ga RM2

    Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA11 and then within two weeks Participant will be injected IV with 140 ±20% mBq of 68Ga RM2

    Drug: 68Ga RM2
    PET radiopharmaceutical
    Other Names:
  • 68Ga DOTA Bombesin
  • BAY86 7548

    • Drug: 68Ga-PSMA-11
    PET radiopharmaceutical
    Other Names:
  • DFKZ 11
  • HBED CC PSMA
  • Heidelberg compound

    • Device: Investigational PET scanner coils and software
    GE Healthcare non-approved PET scanner coils and software

    Outcome Measures

    Primary Outcome Measures

    1. PET based Biopsy Guidance [12 months]

      PET based Biopsy Guidance will be assessed as number of participants with biopsy results correlated with imaging findings (ie, prostate uptake on 68Ga PSMA 11 and 68Ga RM2 scans). The outcome will be reported as the number of participants without dispersion for which PET based biopsy guidance is successfully obtained.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford University Stanford California United States 94305

    Sponsors and Collaborators

    • Andrei Iagaru
    • General Electric

    Investigators

    • Principal Investigator: Andrei H Iagaru, MD, Stanford University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Andrei Iagaru, Associate Professor of Radiology (Nuclear Medicine), Stanford University
    ClinicalTrials.gov Identifier:
    NCT03809078
    Other Study ID Numbers:
    • IRB-48151
    • PROS0091
    • IRB-48151
    • NCI-2019-00236
    First Posted:
    Jan 18, 2019
    Last Update Posted:
    May 9, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by Andrei Iagaru, Associate Professor of Radiology (Nuclear Medicine), Stanford University
    Prostate Cancer
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Gallium 68 PSMA-11
    Bombesin

    Study Results

    No Results Posted as of May 9, 2022