The Application of 18F-G1 PET/CT Targeting Granzyme B in the Pan-cancer Immunotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 18F-G1.
- Who it may be relevant to
- Registry conditions: Solid Tumors and Hematological Tumors. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
Detailed description
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.
Interventions
- Drug 18F-G1
18F-G1 is injected intravenously with a dose of 0.06-0.08mCi/kg
Primary outcome measures
- Number of participants with 18F-G1-related adverse events (AEs). [Time frame: 3 days after the injection of 18F-G1]
- The vivo accumulation and distribution of 18F-G1 in tumors and major healthy organs. [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. [Time frame: 6 months]
Secondary outcome measures (1)
- Evaluate the correlation of 18F-G1 accumulation in tumors to long term survival after immunotherapy. [Time frame: 3 years]
Eligibility criteria
Inclusion criteria
- 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.
- The expected survival time is ≥6 months.
- Effective contraceptive measures will be adopted during the study period and within 6 months after the study.
- Willing and able to fully understand and sign the informed consent form.
Exclusion criteria
- 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.
- Receiving radiotherapy or interventional therapy during the immunotherapy.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07039474 · 2025R0069