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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

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ClinicalTrials.gov Identifier: NCT03949517
Recruitment Status : Recruiting
First Posted : May 14, 2019
Last Update Posted : May 16, 2019
Sponsor:
Collaborator:
General Electric
Information provided by (Responsible Party):
Andrei Iagaru, Stanford University

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.

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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 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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)




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.



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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)

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


Contacts
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Contact: Shahryar Niknam 650-721-4080 sniknam@stanford.edu

Locations
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United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Shahryar Niknam    650-721-4080    sniknam@stanford.edu   
Sponsors and Collaborators
Andrei Iagaru
General Electric
Investigators
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Principal Investigator: Andrei H Iagaru, MD Stanford University

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Responsible Party: Andrei Iagaru, Professor of Radiology (Nuclear Medicine), Stanford University
ClinicalTrials.gov Identifier: NCT03949517     History of Changes
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 16, 2019
Last Verified: May 2019
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
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

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
Genital Diseases, Male
Prostatic Diseases
Edetic Acid
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action