68Ga-P16-093 and 18F-FDG PET/CT Imaging in the Same Group of Clear Cell Renal Cell Carcinoma Patients
A Pilot Comparison of 68Ga-P16-093 and 18F-FDG PET/CT Imaging in the Same Group of Clear Cell Renal Cell Carcinoma Patients
1 other identifier
interventional
42
1 country
1
Brief Summary
PSMA is highly expressed on the cell surface of the microvasculature of several solid tumors, including clear cell renal cell carcinoma (ccRCC). This makes it a potentially imaging target for the detection of ccRCC. This pilot study was designed to evaluate the diagnostic performance of 68Ga-P16-093, a novel radiopharmaceutical targeting PSMA, which was compared with 18F-FDG PET/CT in the same group of ccRCC patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 14, 2022
CompletedFirst Submitted
Initial submission to the registry
June 21, 2022
CompletedFirst Posted
Study publicly available on registry
June 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 4, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2022
CompletedNovember 3, 2022
September 1, 2022
5 months
June 21, 2022
November 1, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Diagnostic performance
comparing the number of tumor detected by 68Ga-P16-093 and 18F-FDG PET/CT
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 18F-FDG PET/ CT scan
EXPERIMENTALWithin 1 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-P16-093 and 18F-FDG, respectively.
Interventions
Intravenous injection of 68Ga-P16-093 with a dosage of 1.8-2.2 MBq (0.05-0.06 mCi)/kg.
Intravenous injection of 18F-FDG with a dosage of 5.55 MBq (0.15 mCi)/kg.
Eligibility Criteria
You may qualify if:
- patients with confirmed or suspected clear cell Renal cell carcinoma;
- Ga-P16-093 18F-FDG PET/CT within a week;
- signed written consent.
You may not qualify if:
- pregnancy;
- breastfeeding;
- 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
Related Publications (1)
Wang G, Li L, Wang J, Zang J, Chen J, Xiao Y, Fan X, Zhu L, Kung HF, Zhu Z. Head-to-head comparison of [68Ga]Ga-P16-093 and 2-[18F]FDG PET/CT in patients with clear cell renal cell carcinoma: a pilot study. Eur J Nucl Med Mol Imaging. 2023 Apr;50(5):1499-1509. doi: 10.1007/s00259-022-06101-3. Epub 2023 Jan 5.
PMID: 36600099DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhaohui Zhu, MD
Peking Union Medical College Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2022
First Posted
June 27, 2022
Study Start
April 14, 2022
Primary Completion
September 4, 2022
Study Completion
September 15, 2022
Last Updated
November 3, 2022
Record last verified: 2022-09