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A Pilot Study of 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for Biopsy Guidance in Patients With Suspected Prostate Cancer

Primary Purpose

Prostate Cancer

Status

Suspended

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

68Ga RM2

68Ga-PSMA-11

Investigational PET scanner coils and software

About this trial

This is an interventional diagnostic 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:

Suspected prostate cancer
Planned prostate biopsy
Able to provide written consent
Karnofsky performance status of 50 (or ECOG/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

Arm Label

68Ga RM2 first followed by 68Ga PSMA11

68Ga PSMA11 first followed by 68Ga RM2

Arm Description

Participant will be injected IV with 140 ±20% mBq of 68Ga RM2 and then within two weeks Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA11

Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA11 and then within two weeks Participant will be injected IV with 140 ±20% mBq of 68Ga RM2

Outcomes

Primary Outcome Measures

PET based Biopsy Guidance

PET based Biopsy Guidance will be assessed as number of participants with biopsy results correlated with imaging findings (ie, prostate uptake on 68Ga PSMA 11 and 68Ga RM2 scans). The outcome will be reported as the number of participants without dispersion for which PET based biopsy guidance is successfully obtained.

Secondary Outcome Measures

Full Information

NCT ID

NCT03809078

First Posted

January 16, 2019

Last Updated

May 3, 2022

Sponsor

Andrei Iagaru

Collaborators

General Electric

1. Study Identification

Unique Protocol Identification Number

NCT03809078

Brief Title

A Pilot Study of 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for Biopsy Guidance in Patients With Suspected Prostate Cancer

Official Title

A Pilot Study of 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for Biopsy Guidance in Patients With Suspected Prostate Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Suspended

Why Stopped

Business decision - funding

Study Start Date

January 14, 2019 (Actual)

Primary Completion Date

August 2023 (Anticipated)

Study Completion Date

February 2024 (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

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The objective of the study is to evaluate 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for biopsy guidance in patients with suspected prostate cancer.

Detailed Description

Primary Objective: To evaluate 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for biopsy guidance in patients with suspected prostate cancer. Exploratory Objective: Correlation of 68Ga PSMA 11 uptake and Gleason score at biopsy Correlation of 68Ga RM2 and Gleason score at biopsy

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

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

68Ga RM2 first followed by 68Ga PSMA11

Arm Type

Experimental

Arm Description

Participant will be injected IV with 140 ±20% mBq of 68Ga RM2 and then within two weeks Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA11

Arm Title

68Ga PSMA11 first followed by 68Ga RM2

Arm Type

Experimental

Arm Description

Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA11 and then within two weeks Participant will be injected IV with 140 ±20% mBq of 68Ga RM2

Intervention Type

Drug

Intervention Name(s)

68Ga RM2

Other Intervention Name(s)

68Ga DOTA Bombesin, BAY86 7548

Intervention Description

PET radiopharmaceutical

Intervention Type

Drug

Intervention Name(s)

68Ga-PSMA-11

Other Intervention Name(s)

DFKZ 11, HBED CC PSMA, Heidelberg compound

Intervention Description

PET radiopharmaceutical

Intervention Type

Device

Intervention Name(s)

Investigational PET scanner coils and software

Intervention Description

GE Healthcare non-approved PET scanner coils and software

Primary Outcome Measure Information:

Title

PET based Biopsy Guidance

Description

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Suspected prostate cancer Planned prostate biopsy Able to provide written consent Karnofsky performance status of 50 (or ECOG/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

Learn more about this trial

A Pilot Study of 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for Biopsy Guidance in Patients With Suspected Prostate Cancer

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