68-Ga PSMA 11 PET/MRI and 68-Ga RM2 PET/MRI for Evaluation of Prostate Cancer Response to HIFU Therapy

January 26, 2024 updated by: Andrei Iagaru

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants for Which an Assessment of PET Based Therapeutic Response to HIFU is Successfully Obtained
Time Frame: Up to approximately 2 hours to complete each scan
Positron emission tomography (PET) based of Assessment of Local Therapeutic Response. Therapeutic response to HIFU will be assessed by 68-Ga PSMA 11 and 68-Ga RM2 PET scans.
Up to approximately 2 hours to complete each scan

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andrei Iagaru

Collaborators

General Electric

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2019

Primary Completion (Actual)

March 7, 2022

Study Completion (Actual)

March 7, 2022

Study Registration Dates

First Submitted

May 10, 2019

First Submitted That Met QC Criteria

May 10, 2019

First Posted (Actual)

May 14, 2019

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 26, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-48213 (Other Identifier: Stanford IRB)
  • PROS0093 (Other Identifier: OnCore)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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