NCT03809078

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_2 prostate-cancer

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 14, 2019

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 18, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2022

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

January 11, 2024

Completed
Last Updated

January 11, 2024

Status Verified

January 1, 2024

Enrollment Period

3.1 years

First QC Date

January 16, 2019

Results QC Date

December 1, 2023

Last Update Submit

January 9, 2024

Conditions

Prostate Cancer

Keywords

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Biopsy Results Correlated With PET Based Imaging Findings

    Measure of PET based Biopsy Guidance (ie, prostate uptake on 68Ga PSMA 11 and 68Ga RM2 scans).

    Up to approximately 2 hours to complete each scan

Study Arms (2)

68Ga RM2 first followed by 68Ga PSMA11

EXPERIMENTAL

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

Drug: 68Ga RM2Drug: 68Ga-PSMA-11Device: Investigational PET scanner coils and software

68Ga PSMA11 first followed by 68Ga RM2

EXPERIMENTAL

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

Drug: 68Ga RM2Drug: 68Ga-PSMA-11Device: Investigational PET scanner coils and software

Interventions

68Ga RM2DRUG

PET radiopharmaceutical

Also known as: 68Ga DOTA Bombesin, BAY86 7548
68Ga PSMA11 first followed by 68Ga RM268Ga RM2 first followed by 68Ga PSMA11
68Ga-PSMA-11DRUG

PET radiopharmaceutical

Also known as: DFKZ 11, HBED CC PSMA, Heidelberg compound
68Ga PSMA11 first followed by 68Ga RM268Ga RM2 first followed by 68Ga PSMA11
Investigational PET scanner coils and softwareDEVICE

GE Healthcare non-approved PET scanner coils and software

68Ga PSMA11 first followed by 68Ga RM268Ga RM2 first followed by 68Ga PSMA11

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (1)

  • Duan H, Ghanouni P, Daniel B, Rosenberg J, Thong A, Kunder C, Aparici CM, Davidzon GA, Moradi F, Sonn GA, Iagaru A. A Pilot Study of 68Ga-PSMA11 and 68Ga-RM2 PET/MRI for Biopsy Guidance in Patients with Suspected Prostate Cancer. J Nucl Med. 2023 May;64(5):744-750. doi: 10.2967/jnumed.122.264448. Epub 2022 Nov 17.

    PMID: 36396456RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

BAY 86-7548gallium 68 PSMA-11

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Results Point of Contact

Title
Dr. Andrei Iagaru, MD
Organization
Stanford University
aiagaru@stanford.edu
650-725-4711

Study Officials

  • Andrei H Iagaru, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Radiology (Nuclear Medicine)

Study Record Dates

First Submitted

January 16, 2019

First Posted

January 18, 2019

Study Start

January 14, 2019

Primary Completion

March 8, 2022

Study Completion

March 8, 2022

Last Updated

January 11, 2024

Results First Posted

January 11, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)