Status:
NOT_YET_RECRUITING
Granzyme B-targeted PET Imaging Monitoring Tumor Responses to Immunotherapy
Lead Sponsor:
Zhongnan Hospital
Conditions:
PET/CT
Solid Tumors, Adult
Eligibility:
All Genders
18-90 years
Brief Summary
Malignant solid tumors, characterized by their persistently high incidence and mortality rates, pose a significant threat to human health and life, imposing a substantial societal burden. Molecular im...
Detailed Description
This investigator-initiated trial (IIT) aims to investigate the clinical utility of Granzyme B (GZMB)-targeted PET imaging for the early prediction of immunotherapy response in patients with malignant...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Voluntarily participate and sign the written informed consent form.
- Aged 18 to 90 years (inclusive), regardless of gender.
- Treatment-naïve patients with pathologically confirmed malignant solid tumors scheduled to receive immunotherapy.
- Willing and able to adhere to scheduled visits, treatment plans, and laboratory tests.
- Exclusion Criteria
- Pregnant or lactating patients.
- Patients with a known allergy to GZMB-targeted imaging agents or synthetic excipients.
- Fasting blood glucose level exceeding 11.0 mmol/L prior to 18F-FDG administration.
- Patients unable to undergo PET/CT imaging (e.g., inability to lie supine, claustrophobia, severe anxiety related to radiation exposure).
- Patients with poor compliance or other factors deemed by the investigator to preclude participation in the study.
Exclusion
Key Trial Info
Start Date :
April 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06916442
Start Date
April 1 2025
End Date
December 31 2027
Last Update
April 8 2025
Active Locations (1)
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1
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430071