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NCT07039474
The Application of 18F-G1 PET/CT Targeting Granzyme B in the Pan-cancer Immunotherapy
Conditions: Solid Tumor Malignancies, Hematologic Cancer, Lung Cancer, Esophagus Cancer, Breast Cancer, Kidney Cancer, Stomach Cancer, Lymphoma
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: Yes
Enrollment: 120
Sponsor: Peking University First Hospital
Location: Peking University First Hospital Beijing
Summary
The purpose of this study is to explore the effectiveness of 18F-G1 PET/CT in patients with solid tumors and hematological malignancies receiving immunotherapy
Eligibility Criteria
Inclusion Criteria:
1. Subjects diagnosed with a malignant tumor by histopathology who are going to receive immunotherapy (monotherapy or combined immunotherapy) recommended by the multidisciplinary team.
2. Subjects didn't receive previous immunotherapy.
3. There exists at least one measurable target lesion according to the RECIST 1.1.
4. ECOG performance status≤2.
5. The expected survival time is ≥6 months.
6. Effective contraceptive measures will be adopted during the study period and within 6 months after the study.
7. Willing and able to fully understand and sign the informed consent form.
Exclusion Criteria:
1. Women in the preconception period, pregnancy, or lactation period.
2. Combined with other malignant tumor.
3. Diagnosed with autoimmune disease, or have long history of systemic steroid hormone therapy or immunosuppressive therapy.
4. Having a history of severe cardiovascular disease, severe hepatic and renal insufficiency.
5. Receiving radiotherapy or interventional therapy during the immunotherapy.
6. 18F-G1 PET/CT or 18F-FDG PET/CT is not performed in our department, or the interval between baseline imaging and immunotherapy is more than 30 days.
Source: ClinicalTrials.gov (NCT07039474). StuddyBuddy aggregates publicly available trial information.