68Ga-BNU-PSMA PET/CT in Patients With Various Types of Cancer
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Aug 2020
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2020
CompletedStudy Start
First participant enrolled
August 21, 2020
CompletedFirst Posted
Study publicly available on registry
August 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedSeptember 9, 2020
September 1, 2020
2.4 years
August 21, 2020
September 5, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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.
30 days
Secondary Outcomes (2)
Diagnostic efficacy
30 days
Diagnostic efficacy
30 days
Study Arms (1)
68Ga-BNU-PSMA
EXPERIMENTALEach subject receive a single intravenous injection of 68Ga-BNU-PSMA, and undergo PET/CT imaging within the specificed time.
Interventions
Each patient receive a single intravenous injection of 68Ga-BNU-PSMA, and undergo PET/CT scan within specified time.
Eligibility Criteria
You may qualify if:
- (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).
You may not qualify if:
- (i) patients with pregnancy; (ii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Department of Nuclear Medicine
Study Record Dates
First Submitted
August 21, 2020
First Posted
August 25, 2020
Study Start
August 21, 2020
Primary Completion
December 30, 2022
Study Completion
December 30, 2022
Last Updated
September 9, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share