About this trial
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
This trial accepts healthy volunteersQualifiers
Subjects diagnosed with a malignant tumor by histopathology who are going to receive immunotherapy (monotherapy or combined immunotherapy) recommended by the multidisciplinary team.
Subjects didn't receive previous immunotherapy.
There exists at least one measurable target lesion according to the RECIST 1.1.
ECOG performance status≤2.
Disqualifiers
Women in the preconception period, pregnancy, or lactation period.
Combined with other malignant tumor.
Diagnosed with autoimmune disease, or have long history of systemic steroid hormone therapy or immunosuppressive therapy.
Having a history of severe cardiovascular disease, severe hepatic and renal insufficiency.
Trial population
Subjects diagnosed with a malignant tumor (solid tumor or hematological tumor) by histopathology who are going to receive immunotherapy (monotherapy or combined immunotherapy).
Trial design
Cohort
Prospective
Treatments tested in this trial
18F-G1
Drug18F-G1 is injected intravenously with a dose of 0.06-0.08mCi/kg
Treatment groups
Trial outcomes
Primary outcomes
Number of participants with 18F-G1-related adverse events (AEs).
The absolute number of participants with AEs after the injection of 18F-G1 according to CTCAE 5.0.
Tumor uptake of 18F-G1
The uptake of 18F-G1 in tumors will be quantitatively assessed by SUVmax.
Liver uptake of 18F-G1
The uptake of 18F-G1 in liver will be quantitatively assessed by SUVmax.
Lung uptake of 18F-G1
The uptake of 18F-G1 in lung will be quantitatively assessed by SUVmax.
Secondary outcomes
Evaluate the correlation of 18F-G1 accumulation in tumors to long term survival after immunotherapy.
Participants will be categorized into groups with high or low 18F-G1 uptake in tumor lesions. The progression-free survival (PFS) as assessed by RECIST 1.1 criteria or Lugano criteria will be compared between the two groups.
Sponsors and contacts
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