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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

Primary Purpose

Prostate Cancer

Status
Suspended
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
68-Ga RM2
68-Ga PSMA11
Investigational software and coils in PET/MR Scan
PET/MRI
Sponsored by
Andrei Iagaru
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

68-Ga RM2+68-Ga PSMA11

68-Ga PSMA11+68-Ga RM2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Positron emission tomography (PET) based of Assessment of Local Therapeutic Response
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.

Secondary Outcome Measures

Full Information

First Posted
May 10, 2019
Last Updated
May 3, 2022
Sponsor
Andrei Iagaru
Collaborators
General Electric
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1. Study Identification

Unique Protocol Identification Number
NCT03949517
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Suspended
Why Stopped
Business decision
Study Start Date
April 9, 2019 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Andrei Iagaru
Collaborators
General Electric

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
68-Ga RM2+68-Ga PSMA11
Arm Type
Experimental
Arm Description
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
Arm Title
68-Ga PSMA11+68-Ga RM2
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
68-Ga RM2
Other Intervention Name(s)
68Ga-DOTA-4-amino-1-carboxymethyl-piperidine-DPhe-Gln-Trp-Ala-Val-Gly-His-Sta-Leu-NH2, 68Ga-DOTA-Bombesin, BAY86-7548
Intervention Description
Radioactive agent
Intervention Type
Drug
Intervention Name(s)
68-Ga PSMA11
Other Intervention Name(s)
DFKZ 11, HBED CC PSMA, Heidelberg compound
Intervention Description
Radioactive agent
Intervention Type
Device
Intervention Name(s)
Investigational software and coils in PET/MR Scan
Intervention Description
Investigational software and coils in PET/MR Scan by General Electric Healthcare
Intervention Type
Procedure
Intervention Name(s)
PET/MRI
Other Intervention Name(s)
Positron emission tomography (PET)/Magnetic resonance imaging (MRI)
Intervention Description
Positron emission tomography (PET)/Magnetic resonance imaging (MRI) Scan
Primary Outcome Measure Information:
Title
Positron emission tomography (PET) based of Assessment of Local Therapeutic Response
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrei H Iagaru, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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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