PET/CTNCT05134064
68Ga-PSMA PET/CT Imaging in Assessment of Prostate Cancer
An observational study of PET/CT and Prostate Specific Membrane Antigen, run by RenJi Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- PET/CT, Prostate Specific Membrane Antigen, IMAGE
- What is being tested?
- total-body PET/CT
- Type of treatment
- Medical device
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 31 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The prospective study consisted of 56 patients for 68Ga-PSMA-11 total-body PET/CT examination between December 2020 and July 2021.
Who may be able to join
- 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
Who cannot join
- only one scan was performed
- negative PSMA results
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai jiaotong University School of Medicine, Renji Hospital
Shanghai, Shanghai Municipality, 200127
About this study
Official title: 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.
- Conditions
- PET/CT, Prostate Specific Membrane Antigen, IMAGE
- Being tested
- total-body PET/CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total-body PET/CTDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| PCa patients underwent 1 h p.i. PSMA PET/CT imaging and 3 h p.i. PSMA imaging | Not described Receives: Device: total-body PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Only one-time point scan is possible for PSMA PET/CT
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.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start1 Dec 2020
- Primary completion31 Jul 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PET/CTStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yumei Chen, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05134064
- Sponsor's protocol ID
- 2018-104
- Status last verified
- Nov 2021
- First submitted
- 3 Nov 2021
- Last updated
- 24 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 68Ga-PSMA PET/CT Imaging in Assessment of PCa: Feasibility of Delayed Acquisition on Total-body PET/CT Scanner?
- ClinicalTrials.gov ID
- NCT05134064
- Acronym / sponsor ID
- 2018-104
- Conditions
- PET/CT, Prostate Specific Membrane Antigen, IMAGE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PCa patients underwent 1 h p.i. PSMA PET/CT imaging and 3 h p.i. PSMA imaging | – | Device: total-body PET/CT |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The prospective study consisted of 56 patients for 68Ga-PSMA-11 total-body PET/CT examination between December 2020 and July 2021.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- only one scan was performed
- negative PSMA results
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| total-body PET/CTPCa 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. | Device | PCa patients underwent 1 h p.i. PSMA PET/CT imaging and 3 h p.i. PSMA imaging |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PET/CT and Prostate Specific Membrane Antigen, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Only one-time point scan is possible for PSMA PET/CT (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2021.