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A Pilot Study of 68-Ga PSMA 11 PET/MRI and 68-Ga RM2 PET/MRI for Evaluation of Prostate Cancer Response to HIFU or HDR Therapy

Sponsor
Andrei Iagaru (Other)
Overall Status
Suspended
CT.gov ID
NCT03949517
Collaborator
General Electric (Industry)
10
Enrollment
1
Location
2
Arms
53.7
Anticipated Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is being conducted to determine whether the combination of imaging agents 68-Ga RM2 and 68-Ga PMSA11 is better at assessing response to high intensity focused ultrasound (HIFU) or high dose rate (HDR) local therapy than standard imaging or biopsy in patients with known prostate cancer.

Condition or Disease Intervention/Treatment Phase
  • Drug: 68-Ga RM2
  • Drug: 68-Ga PSMA11
  • Device: Investigational software and coils in PET/MR Scan
  • Procedure: PET/MRI
 Phase 1/Phase 2

Detailed Description

Primary Objective: To determine feasibility of 68Ga-PSMA-11 PET/MRI and 68Ga-RM2 PET/MRI for evaluation of HIFU or HDR local therapy in patients with known prostate cancer.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Pilot Study of 68-Ga PSMA 11 PET/MRI and 68-Ga RM2 PET/MRI for Evaluation of Prostate Cancer Response to HIFU or HDR Therapy
Actual Study Start Date :
Apr 9, 2019
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 68-Ga RM2+68-Ga PSMA11

68-Ga RM2 first followed by 68-Ga PSMA11 within 2 weeks. Participant will be injected IV with 140 ± 20% mBq of 68-Ga RM2 OR 3 to 7 mCi of 68-Ga PSMA11

Drug: 68-Ga RM2
Radioactive agent
Other Names:
  • 68Ga-DOTA-4-amino-1-carboxymethyl-piperidine-DPhe-Gln-Trp-Ala-Val-Gly-His-Sta-Leu-NH2
  • 68Ga-DOTA-Bombesin
  • BAY86-7548

    • Drug: 68-Ga PSMA11
    Radioactive agent
    Other Names:
  • DFKZ 11
  • HBED CC PSMA
  • Heidelberg compound

    • Device: Investigational software and coils in PET/MR Scan
    Investigational software and coils in PET/MR Scan by General Electric Healthcare

    Procedure: PET/MRI
    Positron emission tomography (PET)/Magnetic resonance imaging (MRI) Scan
    Other Names:
  • Positron emission tomography (PET)/Magnetic resonance imaging (MRI)

    		•
    Experimental: 68-Ga PSMA11+68-Ga RM2

    68-Ga PSMA11 first followed by 68-Ga RM2 within 2 weeks. Participant will be injected IV with 140 ± 20% mBq of 68-Ga RM2 OR 3 to 7 mCi of 68-Ga PSMA11

    Drug: 68-Ga RM2
    Radioactive agent
    Other Names:
  • 68Ga-DOTA-4-amino-1-carboxymethyl-piperidine-DPhe-Gln-Trp-Ala-Val-Gly-His-Sta-Leu-NH2
  • 68Ga-DOTA-Bombesin
  • BAY86-7548

    • Drug: 68-Ga PSMA11
    Radioactive agent
    Other Names:
  • DFKZ 11
  • HBED CC PSMA
  • Heidelberg compound

    • Device: Investigational software and coils in PET/MR Scan
    Investigational software and coils in PET/MR Scan by General Electric Healthcare

    Procedure: PET/MRI
    Positron emission tomography (PET)/Magnetic resonance imaging (MRI) Scan
    Other Names:
  • Positron emission tomography (PET)/Magnetic resonance imaging (MRI)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Positron emission tomography (PET) based of Assessment of Local Therapeutic Response [12 months]

      Therapeutic response to high intensity focused ultrasound (HIFU) or high dose rate (HDR) will be assessed by 68-Ga PSMA 11 and 68-Ga RM2 PET scans. The outcome is the number of participants without dispersion, by randomization schedule, for which an assessment of PET based therapeutic response to HIFU or HDR 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:

    • Known prostate cancer

    • Planned HIFU or HDR local therapy

    • Able to provide written consent

    • Karnofsky performance status of 50 (or Eastern Cooperative Oncology Group (ECOG) /World Health Organization (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, Professor of Radiology (Nuclear Medicine), Stanford University
    ClinicalTrials.gov Identifier:
    NCT03949517
    Other Study ID Numbers:
    • IRB-48213
    • PROS0093
    • IRB-48213
    First Posted:
    May 14, 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, Professor of Radiology (Nuclear Medicine), Stanford University
    Prostate Cancer
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Piperidine
    Gallium 68 PSMA-11
    Bombesin

    Study Results

    No Results Posted as of May 9, 2022