Status:
UNKNOWN
68Ga-FAPI-04 PET Imaging in Early Response Evaluation of Rectal Cancer Patients Treated With Immunotherapy
Lead Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions:
Rectal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is a prospective monocentric study aimed to explore the value of 68Ga-FAPI-04 PET imaging in early response evaluation of rectal cancer patients treated with immunotherapy. Patients with hi...
Detailed Description
The response patterns of immune checkpoint inhibitors (ICIs) in solid tumors are diverse and complicated. Pseudoprogression, progression and even hyperprogression can occur. The main mechanism of pseu...
Eligibility Criteria
Inclusion
- Histologically confirmed T3-4N0M0 or T1-4N+M0 (according to the 8th edition of the International Union Against Cancer TNM staging system) rectal adenocarcinoma and treatment naïve;
- No severe hematologic, cardiac, pulmonary, hepatic, or renal functional abnormalities or immunodeficiency diseases;
- An Eastern Cooperative Oncology Group Performance Status of 0-1;
- Patients who agree to undergo 68Ga-FAPI-04 and 18F-FDG PET imaging.
Exclusion
- Any experiences of anti-programmed death ligand 1 (PD-L1) or anti-PD-1 antibody treatment;
- A history of pelvic radiation;
- The presence of autoimmune disease;
- Hypersensitive to any monoclonal antibodies;
- History of interstitial lung disease;
- Active and uncontrolled infection.
Key Trial Info
Start Date :
June 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05999227
Start Date
June 20 2023
End Date
July 31 2024
Last Update
August 21 2023
Active Locations (1)
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1
China, Hubei Province
Wuhan, Hubei, China, 430022