68Ga-P16-093 PET/CT Imaging in Glioma Patients
1 other identifier
interventional
50
1 country
1
Brief Summary
PSMA is highly expressed on the cell surface of the microvasculature of several solid tumors, including glioma. This makes it a potentially imaging target for the detection and grading of gliomas. This pilot study was designed to evaluate the diagnostic performance of 68Ga-P16-093, a novel radiopharmaceutical targeting PSMA, which was compared with MRI in the same group of glioma patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2021
Typical duration for 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
Study Start
First participant enrolled
November 28, 2021
CompletedFirst Submitted
Initial submission to the registry
October 4, 2022
CompletedFirst Posted
Study publicly available on registry
October 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedOctober 6, 2022
October 1, 2022
2 years
October 4, 2022
October 4, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Diagnostic performance
comparing the number of tumor detected by 68Ga-P16-093 and MRI
through study completion, an average of 1 year
Secondary Outcomes (1)
standardized uptake value (SUV) of tumor
through study completion, an average of 1 year
Study Arms (1)
68Ga-P16-093 and MRI scan
EXPERIMENTALWithin 1 week, each patient underwent MRI scan and PET/CT scan after intravenous administration of 68Ga-P16-093, respectively.
Interventions
Intravenous injection of 68Ga-P16-093 with the dosage of 1.5-1.8 MBq (0.04-0.05 mCi)/kg. Tracer doses of 68Ga-P16-093 will be used to image lesions of glioma by PET/CT.
Eligibility Criteria
You may qualify if:
- glioma patients highly suggested by MRI or histologically confirmed;
- Ga-P16-093 PET/CT and MRI within two weeks;
- signed written consent.
You may not qualify if:
- known allergy against PSMA;
- any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhaohui Zhu, MD
Peking Union Medical College Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2022
First Posted
October 6, 2022
Study Start
November 28, 2021
Primary Completion
December 1, 2023
Study Completion
December 1, 2024
Last Updated
October 6, 2022
Record last verified: 2022-10