An observational study in Solid Tumor Malignancies, Hematologic Cancer and Lung Cancer, sponsored by Peking University First Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Peking University First Hospital · Observational
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
It is urgent to select patients who will benefit from immunotherapy, so as to help the clinicians adjust the regimens and avoid unnecessary side effect. 18F-G1 is a new radioactive tracer targeting granzyme B, holding great promise in assessing early response to immunotherapy. This study will explore the safety of 18F-G1 PET/CT in patients with solid tumors and hematological tumors receiving immunotherapy, analyze its imaging features, and assess its efficacy in predicting early immunotherapy response and prognosis, so as to aid the clinicians in precise patient stratification and regimen adjustment.
Subjects diagnosed with a malignant tumor (solid tumor or hematological tumor) by histopathology who are going to receive immunotherapy (monotherapy or combined immunotherapy).
Exclusion Criteria:
18F-G1 is injected intravenously with a dose of 0.06-0.08mCi/kg
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.
Time frame: 3 days after the injection of 18F-G1
Tumor uptake of 18F-G1
The uptake of 18F-G1 in tumors will be quantitatively assessed by SUVmax.
Time frame: 40-60 minutes after the injection of 18F-G1
Liver uptake of 18F-G1
The uptake of 18F-G1 in liver will be quantitatively assessed by SUVmax.
Time frame: 40-60 minutes after the injection of 18F-G1
Lung uptake of 18F-G1
The uptake of 18F-G1 in lung will be quantitatively assessed by SUVmax.
Time frame: 40-60 minutes after the injection of 18F-G1
Kidney uptake of 18F-G1
The uptake of 18F-G1 in kidney will be quantitatively assessed by SUVmax.
Time frame: 40-60 minutes after the injection of 18F-G1
the granzyme B specificity of 18F-G1
Time frame: 3 years
Assessing the early predictive value of 18F-G1 PET/CT for immunotherapy response.
Participants' overall response will be assessed by RECIST 1.1 criteria or Lugano criteria at the time point of 6 months after immunotherapy. The tumor uptake of 18F-G1 will be compared between the responders and non-responders.
Time frame: 6 months
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.
Time frame: 3 years
Plan to share: No
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Peking University First Hospital