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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03949517
Recruitment Status : Suspended (Business decision)
First Posted : May 14, 2019
Last Update Posted : May 9, 2022
Sponsor:
Collaborator:
General Electric
Information provided by (Responsible Party):
Andrei Iagaru, Stanford University

Study Description
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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
Prostate Cancer 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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 9, 2019
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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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 Name: 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 Name: Positron emission tomography (PET)/Magnetic resonance imaging (MRI)


Outcome Measures
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Primary Outcome Measures :
  1. Positron emission tomography (PET) based of Assessment of Local Therapeutic Response [ Time Frame: 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
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03949517


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Andrei Iagaru
General Electric
Investigators
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Principal Investigator: Andrei H Iagaru, MD Stanford University
More Information
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Responsible Party: Andrei Iagaru, Professor of Radiology (Nuclear Medicine), Stanford University
ClinicalTrials.gov Identifier: NCT03949517    
Other Study ID Numbers: IRB-48213
PROS0093 ( Other Identifier: OnCore )
IRB-48213 ( Other Identifier: Stanford IRB )
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: May 9, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Andrei Iagaru, Stanford University:
Prostate Cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Piperidine
Gallium 68 PSMA-11
 Bombesin
Molecular Mechanisms of Pharmacological Action
Radiopharmaceuticals
Neurotransmitter Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents