Back to results68Ga-BNU-PSMA PET/CT in Patients With Various Types of Cancer
Primary Purpose
Tumor, Positron-Emission Tomography, Metastasis
Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
68Ga-BNU-PSMA
Sponsored by
About this trial
This is an interventional diagnostic trial for Tumor
Eligibility Criteria
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.
Sites / Locations
- The First Affiliated Hospital of Fujian Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
68Ga-BNU-PSMA
Arm Description
Each subject receive a single intravenous injection of 68Ga-BNU-PSMA, and undergo PET/CT imaging within the specificed time.
Outcomes
Primary Outcome Measures
Standardized uptake value (SUV)
Standardized uptake value (SUV) of 68Ga-BNU-PSMA for each target lesion of subject or suspected primary tumor or/and metastasis.
Secondary Outcome Measures
Diagnostic efficacy
The sensitivity, specificity and accuracy of 68Ga-BNU-PSMA PET/CT were calculated.
Diagnostic efficacy
The positive predictive value (PPV), negative predictive value (NPV)
Full Information
NCT ID
NCT04525612
First Posted
August 21, 2020
Last Updated
September 5, 2020
Sponsor
First Affiliated Hospital of Fujian Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04525612
Brief Title
68Ga-BNU-PSMA PET/CT in Patients With Various Types of Cancer
Official Title
68Ga-BNU-PSMA PET/CT in Patients With Various Types of Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 21, 2020 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital of Fujian Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tumor, Positron-Emission Tomography, Metastasis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
68Ga-BNU-PSMA
Arm Type
Experimental
Arm Description
Each subject receive a single intravenous injection of 68Ga-BNU-PSMA, and undergo PET/CT imaging within the specificed time.
Intervention Type
Diagnostic Test
Intervention Name(s)
68Ga-BNU-PSMA
Other Intervention Name(s)
PET/CT scan
Intervention Description
Each patient receive a single intravenous injection of 68Ga-BNU-PSMA, and undergo PET/CT scan within specified time.
Primary Outcome Measure Information:
Title
Standardized uptake value (SUV)
Description
Standardized uptake value (SUV) of 68Ga-BNU-PSMA for each target lesion of subject or suspected primary tumor or/and metastasis.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Diagnostic efficacy
Description
The sensitivity, specificity and accuracy of 68Ga-BNU-PSMA PET/CT were calculated.
Time Frame
30 days
Title
Diagnostic efficacy
Description
The positive predictive value (PPV), negative predictive value (NPV)
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weibing Miao, MD
Phone
86-0591-87981618
Email
miaoweibing@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shaobo Yao, MD
Phone
86-0591-87981619
Email
yaoshaobo008@163.com
Facility Information:
Facility Name
The First Affiliated Hospital of Fujian Medical University
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350005
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weibing Miao, MD
Phone
86-0591-87981618
Email
miaoweibing@126.com
First Name & Middle Initial & Last Name & Degree
Shaobo Yao, MD
Phone
86-0591-87981619
Email
yaoshaobo008@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
68Ga-BNU-PSMA PET/CT in Patients With Various Types of Cancer
We'll reach out to this number within 24 hrs