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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-G1 | Drug | 18F-G1 is injected intravenously with a dose of 0.06-0.08mCi/kg |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 days after the injection of 18F-G1 |
| The vivo accumulation and distribution of 18F-G1 in tumors and major healthy organs. | The accumulation and distribution of 18F-G1 in tumors and major healthy organs, such as liver, lung, kidney, will be quantitatively and qualitatively examined. | 40-60 minutes after the injection of 18F-G1 |
| the granzyme B specificity of 18F-G1 | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects diagnosed with a malignant tumor (solid tumor or hematological tumor) by histopathology who are going to receive immunotherapy (monotherapy or combined immunotherapy).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caixia Wu | Contact | 010-83575252 | wucaixia314@163.com |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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