- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04525612
68Ga-BNU-PSMA PET/CT in Patients With Various Types of Cancer
September 5, 2020 updated by: Weibing Miao, PhD, First Affiliated Hospital of Fujian Medical University
To evaluate the potential usefulness of 68Ga-BNU-PSMA positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Subjects with various types of cancer underwent 68Ga-BNU-PSMA PET/CT either for an initial assessment or for recurrence detection.
Tumor uptake was quantified by the maximum standard uptake value (SUVmax).
The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga-BNU-PSMA PET/CT were calculated.
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Early Phase 1
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
-
-
Fujian
-
Fuzhou, Fujian, China, 350005
- Recruiting
- The First Affiliated Hospital of Fujian Medical University
-
-
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
18 years to 90 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- (i) adult population (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled 68Ga-BNU-PSMA PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee; (v) healthy volunteers(aged 18 years or order).
Exclusion Criteria:
- (i) patients with pregnancy; (ii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
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
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 68Ga-BNU-PSMA
Each subject receive a single intravenous injection of 68Ga-BNU-PSMA, and undergo PET/CT imaging within the specificed time.
|
Each patient receive a single intravenous injection of 68Ga-BNU-PSMA, and undergo PET/CT scan within specified time.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Standardized uptake value (SUV)
Time Frame: 30 days
|
Standardized uptake value (SUV) of 68Ga-BNU-PSMA for each target lesion of subject or suspected primary tumor or/and metastasis.
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnostic efficacy
Time Frame: 30 days
|
The positive predictive value (PPV), negative predictive value (NPV)
|
30 days
|
Diagnostic efficacy
Time Frame: 30 days
|
The sensitivity, specificity and accuracy of 68Ga-BNU-PSMA PET/CT were calculated.
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
August 21, 2020
Primary Completion (ANTICIPATED)
December 30, 2022
Study Completion (ANTICIPATED)
December 30, 2022
Study Registration Dates
First Submitted
August 21, 2020
First Submitted That Met QC Criteria
August 21, 2020
First Posted (ACTUAL)
August 25, 2020
Study Record Updates
Last Update Posted (ACTUAL)
September 9, 2020
Last Update Submitted That Met QC Criteria
September 5, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FirstAHFujian5
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
No
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.
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