Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

68Ga-PSMA PET/CT or PET/MRI in Evaluating Patients With Recurrent Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02488070
Recruitment Status : Completed
First Posted : July 2, 2015
Results First Posted : March 14, 2017
Last Update Posted : March 20, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Andrei Iagaru, Stanford University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This clinical trial studies gallium-68 (68Ga)-prostate specific membrane antigen (PSMA) (gallium Ga 68-labeled PSMA ligand Glu-urea-Lys[Ahx]) positron emission tomography (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MRI) in identifying prostate cancer that may have returned after a period of improvement (biochemical recurrence). 68Ga-PSMA is a radiopharmaceutical that localizes to a specific prostate cancer receptor, which can then be imaged by the PET/CT or PET/MRI scanner.

Condition or disease Intervention/treatment Phase
Recurrent Prostate Carcinoma Procedure: Computed Tomography Drug: Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx) Procedure: Magnetic Resonance Imaging Procedure: Positron Emission Tomography Phase 1 Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

Evaluate the feasibility and biodistribution of 68Ga-PSMA.

OUTLINE:

Patients are injected with 5 mCi of Ga68 PSMA intravenously (IV) and then undergo PET/CT or PET/MRI approximately 45 to 60 minutes later.

After completion of study, patients are followed up at 24 hours and 1 week.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 68Ga-PSMA PET/CT or PET/MRI in the Evaluation of Patients With Prostate Cancer: A Feasibility Study
Actual Study Start Date : June 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Diagnostic (68Ga-PSMA PET/CT or PET/MRI)
Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) IV and then undergo PET/CT or PET/MRI approximately 45-60 minutes later.
 Procedure: Computed Tomography
Part of PET/CT scan
Other Names:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT SCAN
  • tomography

Drug: Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx)
Intravenously-administered (IV) radioisotope
Other Names:
  • (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC
  • (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC
  • 68Ga-HBED-CC-PSMA
  • ProstaMedix

Procedure: Magnetic Resonance Imaging
Part of PET/MRI scan
Other Names:
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MRI
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging

Procedure: Positron Emission Tomography
Part of PET/CT and/or PET/MRI scans
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET SCAN
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Average SUVmax of Ga68 PSMA Uptake Outside the Expected Normal Biodistribution [ Time Frame: an estimated average of 1 hour ]
    The biodistribution (ie, the location(s) of physiologic radiopharmaceutical uptake within the body) of Ga68 PSMA will be evaluated using PET/CT or PET/MRI. Biodistribution will be measured by drawing regions of interest (ROI) around areas with visually appreciable increased focal uptake over background (mediastinal blood pool) and calculating a standardized uptake value maximum (SUVmax), which is a semi-quantitative measurement of the maximum value of radiopharmaceutical uptake within the ROI.

  2. Average SUVmean of Ga68 PSMA Uptake Outside the Expected Normal Biodistribution [ Time Frame: an estimated average of 1 hour ]
    The biodistribution (ie, the location(s) of physiologic radiopharmaceutical uptake within the body) of Ga68 PSMA will be evaluated using PET/CT or PET/MRI. Biodistribution will be measured by drawing regions of interest (ROI) around areas with visually appreciable increased focal uptake over background (mediastinal blood pool) and calculating a SUVmean which is a semi-quantitative measurement of the average value of radiopharmaceutical uptake within the ROI.

  3. Average SUVmax Focal Uptake of Ga68 PSMA (F/N Ratio) [ Time Frame: an estimated average of 1 hour ]
    Focal uptake will be measured by drawing regions-of-interest (ROI) around areas with visually appreciable increased focal uptake over background (mediastinal blood pool) and calculating a SUVmax (a semi-quantitative measurement of the maximum value of radiopharmaceutical uptake within the ROI). The result will be expressed as the F/N ratio, ie, SUVmax of focal uptake divided by SUVmax of background.

  4. Average SUVmean Focal Uptake of Ga68 PSMA (F/N Ratio) [ Time Frame: an estimated average of 1 hour ]
    Focal uptake will be measured by drawing regions-of-interest (ROI) around areas with visually appreciable increased focal uptake over background (mediastinal blood pool) and calculating a SUVmean (a semi-quantitative measurement of the average value of radiopharmaceutical uptake within the ROI). The result will be expressed as the F/N ratio, ie, SUVmax of focal uptake divided by SUVmax of background.


Secondary Outcome Measures :
  1. Feasibility of Ga-68 PSMA PET/CT or PET/MRI Scan [ Time Frame: an estimated average of 2 hours ]
    Feasibility of Ga68 PSMA PET/CT or PET/MRI is expressed as the number of subjects for whom the scan was successfully completed.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provides written informed consent
  • Known diagnosis of prostate cancer
  • Patient has suspected recurrence based on biochemical data (prostate specific antigen [PSA] > 2 ng/mL)
  • Able to remain still for duration of each imaging procedure (about one hour)

Exclusion Criteria:

  • Unable to provide informed consent
  • Inability to lie still for the entire imaging time
  • Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
  • Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT02488070


Locations
Layout table for location information
United States, California
Stanford University, School of Medicine
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Andrei Iagaru Stanford Cancer Institute
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Other Publications:

Layout table for additonal information
Responsible Party: Andrei Iagaru, Associate Professor of Radiology, Stanford University
ClinicalTrials.gov Identifier: NCT02488070    
Other Study ID Numbers: IRB-32985
NCI-2015-01067 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
PROS0068 ( Other Identifier: OnCore )
P30CA124435 ( U.S. NIH Grant/Contract )
First Posted: July 2, 2015    Key Record Dates
Results First Posted: March 14, 2017
Last Update Posted: March 20, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
 Edetic Acid
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Calcium Chelating Agents