- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05134064
68Ga-PSMA PET/CT Imaging in Assessment of Prostate Cancer
November 15, 2021 updated by: Yumei Chen, RenJi Hospital
68Ga-PSMA PET/CT Imaging in Assessment of PCa: Feasibility of Delayed Acquisition on Total-body PET/CT Scanner?
Dual-time point 68Ga-PSMA PET/CT could increase the lesion detection in PCa patients, it remains difficult to perform in clinical practice.
The possibility of one-time point 68Ga-PSMA PET/CT imaging could be achieved using a total-body PET/CT.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
66
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200127
- shanghai Jiaotong University School of Medicine, Renji Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Probability Sample
Study Population
The prospective study consisted of 56 patients for 68Ga-PSMA-11 total-body PET/CT examination between December 2020 and July 2021.
Description
Inclusion Criteria:
- primary staging of pathology-confirmed PCa or evidence of BCR with PSA value > 0.2 ng/ml
- positive 68Ga-PSMA findings
- both standard and delayed scans were performed on the total-body PET/CT
Exclusion Criteria:
- only one scan was performed
- negative PSMA results
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
PCa patients underwent 1 h p.i. PSMA PET/CT imaging and 3 h p.i. PSMA imaging
|
PCa patients who underwent PSMA PET/CT in our clinical center received two-time points scans at 1 h p.i. and 3 h p.i. on a total-body PET/CT scanner.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Only one-time point scan is possible for PSMA PET/CT
Time Frame: 8 months
|
By the use of total- body PET/CT scanner, the imaging quality between the 1 h p.i. and 3 h p.i. imaging acquisition are compared.
And the different lesion detection rates at 3 h p.i. and 1 h p.i. are also discussed.
The uptake value differences of all lesions are compared.
|
8 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 1, 2020
Primary Completion (ACTUAL)
July 31, 2021
Study Completion (ACTUAL)
August 31, 2021
Study Registration Dates
First Submitted
November 3, 2021
First Submitted That Met QC Criteria
November 15, 2021
First Posted (ACTUAL)
November 24, 2021
Study Record Updates
Last Update Posted (ACTUAL)
November 24, 2021
Last Update Submitted That Met QC Criteria
November 15, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 2018-104
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on PET/CT
-
University Hospital Inselspital, BerneRecruiting
-
Washington University School of MedicineNational Cancer Institute (NCI)Terminated
-
Sir Mortimer B. Davis - Jewish General HospitalEnrolling by invitation
-
University of CincinnatiNational Cancer Institute (NCI); Ohio Third FrontierActive, not recruitingPET/CT ImagingUnited States
-
Washington University School of MedicineSiemens Corporation, Corporate TechnologyRecruiting
-
Assiut UniversityUnknown
-
Royal Marsden NHS Foundation TrustCity, University of LondonUnknownFDG PET/CT | Skeletal ScintigraphyUnited Kingdom
-
Zhongnan HospitalRecruiting
-
Abdul Latif Jameel Poverty Action LabMassachusetts Institute of Technology; Aurora Health Care; Laura and John Arnold...CompletedCT, MR, NM, and PET Image OrdersUnited States
-
GE HealthcareTerminatedIndication for a PET CT ExamUnited States
Clinical Trials on total-body PET/CT
-
University of California, DavisColorado SPORE Developmental Research ProgramActive, not recruitingHead and Neck CancerUnited States
-
Rigshospitalet, DenmarkRecruiting
-
RenJi HospitalRecruiting
-
RenJi HospitalEnrolling by invitation
-
Sun Yat-sen UniversityCompleted
-
Ontario Clinical Oncology Group (OCOG)Cancer Care OntarioActive, not recruitingMuscle-invasive Bladder CancerCanada
-
RenJi HospitalRecruiting
-
Herlev HospitalCompleted
-
Aarhus University HospitalCompletedPositron-Emission TomographyDenmark
-
University of California, DavisLantheus Medical ImagingEnrolling by invitationBreast Cancer | Prostate Cancer | Neuroendocrine TumorsUnited States