Diagnosis of Renal Cell Carcinoma on 68Ga-PSMA PET-CT and Radioligand Therapy With 177Lu-EB-PSMA-617
1 other identifier
interventional
40
1 country
1
Brief Summary
Renal Cell Carcinoma (RCC) is the second most common tumor in urology. Considering its origination from kidney, an organ with intense physiological uptake and excretion of 68Ga-PSMA, this study aims to evaluate the uptake of 68Ga-PSMA in RCC compared to 18F-FDG in the same patients, and assess the feasibility of 177Lu-EB-PSMA-617 treatment in patients with the advanced RCC.
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 Dec 2021
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
December 1, 2021
CompletedFirst Submitted
Initial submission to the registry
December 24, 2021
CompletedFirst Posted
Study publicly available on registry
December 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2023
CompletedDecember 28, 2021
December 1, 2021
10 months
December 24, 2021
December 24, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Diagnostic value
Sensitivity and Specificity of 68Ga-PSMA PET/CT for Renal Cell Carcinoma in comparison with 18F-FDG PET/CT
through study completion, an average of 1 year
Secondary Outcomes (1)
Safety of therapy
through study completion, an average of 1 year
Other Outcomes (2)
Therapeutic effect
through study completion, an average of 1 year
Correlation between PSMA expression and SUV in PET/CT
through study completion, an average of 1 year
Study Arms (1)
68Ga-PSMA, PET/CT and 177Lu-EB- PSMA-617 therapy
EXPERIMENTALAll patients diagnosed with RCC underwent 68Ga-PSMA PET/CT scan. If the PET/CT showed high PSMA expression in tumor lesions of some patients, they would intravenously injected with the dose about 1.85GBq (50 mCi) of 177Lu-EB-PSMA-617 for therapy.
Interventions
Intravenous injection of one dosage of 74-148 MBq (2-4 mCi) 68Ga-PSMA. Tracer doses of 68Ga- PSMA will be used to image lesions of Renal Cell Carcinoma by PET/CT.
Patients were intravenous injected with the dose about 1.85GBq (50 mCi) of 177Lu-EB-PSMA-617 every 8 weeks (±1 week) for a maximum of 3 cycles.
Eligibility Criteria
You may qualify if:
- confirmed treated or untreated renal cell carcinoma patients;
- Ga-PSMA PET/CT and 18F-FDG PET/CT within two weeks;
- 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhaohui Zhu, MD
Peking Union Medical College Hospital
Central Study Contacts
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
December 24, 2021
First Posted
December 28, 2021
Study Start
December 1, 2021
Primary Completion
October 1, 2022
Study Completion
July 1, 2023
Last Updated
December 28, 2021
Record last verified: 2021-12