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Trial record 26 of 163 for:    PSMA

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

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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 Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition: Recurrent Prostate Carcinoma
Interventions: Procedure: Computed Tomography
Drug: Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx)
Procedure: Magnetic Resonance Imaging
Procedure: Positron Emission Tomography

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Computed Tomography: Undergo PET/CT

Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx): Given IV

Laboratory Biomarker Analysis: Correlative studies

Magnetic Resonance Imaging: Undergo PET/MRI

Positron Emission Tomography: Undergo PET/CT

Positron Emission Tomography: Undergo PET/MRI


Participant Flow:   Overall Study
    Diagnostic (68Ga-PSMA PET/CT or PET/MRI)
STARTED   10 
COMPLETED   10 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Baseline Measures
   Diagnostic (68Ga-PSMA PET/CT or PET/MRI) 
Overall Participants Analyzed 
[Units: Participants]
 10 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      1  10.0% 
>=65 years      9  90.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      10 100.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   10 


  Outcome Measures

1.  Primary:   Average SUVmax of Ga68 PSMA Uptake Outside the Expected Normal Biodistribution   [ Time Frame: an estimated average of 1 hour ]

2.  Primary:   Average SUVmean of Ga68 PSMA Uptake Outside the Expected Normal Biodistribution   [ Time Frame: an estimated average of 1 hour ]

3.  Primary:   Average SUVmax Focal Uptake of Ga68 PSMA (F/N Ratio)   [ Time Frame: an estimated average of 1 hour ]

4.  Primary:   Average SUVmean Focal Uptake of Ga68 PSMA (F/N Ratio)   [ Time Frame: an estimated average of 1 hour ]

5.  Secondary:   Feasibility of Ga-68 PSMA PET/CT or PET/MRI Scan   [ Time Frame: an estimated average of 2 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
lack of correlation with pathology results for all patients; limited patient enrollment (pilot study)


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Andrei Iagaru, MD
Organization: Stanford University
phone: 650-725-4711
e-mail: aiagaru@stanford.edu


Publications of Results:
Other Publications:

Responsible Party: Andrei Iagaru, Stanford University
ClinicalTrials.gov Identifier: NCT02488070     History of Changes
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 Submitted: June 26, 2015
First Posted: July 2, 2015
Results First Submitted: January 23, 2017
Results First Posted: March 14, 2017
Last Update Posted: March 20, 2018