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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

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ClinicalTrials.gov Identifier: NCT03809078
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : January 29, 2019
Sponsor:
Collaborator:
General Electric
Information provided by (Responsible Party):
Andrei Iagaru, Stanford University

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: 68Ga RM2 Drug: 68Ga-PSMA-11 Device: Investigational PET scanner coils and software Phase 2

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : January 14, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 68Ga RM2 first followed by 68Ga PSMA11
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 RM2
PET radiopharmaceutical
Other Names:
  • 68Ga DOTA Bombesin
  • BAY86 7548

Drug: 68Ga-PSMA-11
PET radiopharmaceutical
Other Names:
  • DFKZ 11
  • HBED CC PSMA
  • Heidelberg compound

Device: Investigational PET scanner coils and software
GE Healthcare non-approved PET scanner coils and software

Experimental: 68Ga PSMA11 first followed by 68Ga RM2
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 RM2
PET radiopharmaceutical
Other Names:
  • 68Ga DOTA Bombesin
  • BAY86 7548

Drug: 68Ga-PSMA-11
PET radiopharmaceutical
Other Names:
  • DFKZ 11
  • HBED CC PSMA
  • Heidelberg compound

Device: Investigational PET scanner coils and software
GE Healthcare non-approved PET scanner coils and software




Primary Outcome Measures :
  1. PET based Biopsy Guidance [ Time Frame: 12 months ]
    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.



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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:

  • 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)

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): NCT03809078


Contacts
Contact: Jordan Cisneros 650-725-6409 jordan.cisneros@stanford.edu

Locations
United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Jordan Cisneros         
Principal Investigator: Andrei H Iagaru, MD         
Sub-Investigator: Carina M Aparici         
Sub-Investigator: Bruce Daniel         
Sub-Investigator: Guido Davidzon         
Sub-Investigator: Heying Duan         
Sub-Investigator: Pejman Ghanouni         
Sub-Investigator: Farshad Moradi         
Sub-Investigator: Geoffrey Sonn         
Sponsors and Collaborators
Andrei Iagaru
General Electric
Investigators
Principal Investigator: Andrei H Iagaru, MD Stanford University

Responsible Party: Andrei Iagaru, Associate Professor of Radiology (Nuclear Medicine), Stanford University
ClinicalTrials.gov Identifier: NCT03809078     History of Changes
Other Study ID Numbers: IRB-48151
PROS0091 ( Other Identifier: OnCore )
IRB-48151 ( Other Identifier: Stanford IRB )
NCI-2019-00236 ( Other Identifier: CTRP )
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Andrei Iagaru, Stanford University:
Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Radiopharmaceuticals
Edetic Acid
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents