Clinical Trials in China / NCT07039474
Recruiting
Observational
The Application of 18F-G1 PET/CT Targeting Granzyme B in the Pan-cancer Immunotherapy
NCT07039474 · tracked via the Priya Life Science China tracker
Condition(s) studied
Solid Tumor MalignanciesHematologic CancerLung CancerEsophagus CancerBreast CancerKidney CancerStomach CancerLymphoma
Investigational drug(s) / intervention(s)
18F-G1
18F-G1: 18F-G1 is injected intravenously with a dose of 0.06-0.08mCi/kg
Study 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
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.
Primary outcome measure(s)
- Number of participants with 18F-G1-related adverse events (AEs). — 3 days after the injection of 18F-G1
The absolute number of participants with AEs after the injection of 18F-G1 according to CTCAE 5.0. - Tumor uptake of 18F-G1 — 40-60 minutes after the injection of 18F-G1
The uptake of 18F-G1 in tumors will be quantitatively assessed by SUVmax. - Liver uptake of 18F-G1 — 40-60 minutes after the injection of 18F-G1
The uptake of 18F-G1 in liver will be quantitatively assessed by SUVmax. - Lung uptake of 18F-G1 — 40-60 minutes after the injection of 18F-G1
The uptake of 18F-G1 in lung will be quantitatively assessed by SUVmax. - Kidney uptake of 18F-G1 — 40-60 minutes after the injection of 18F-G1
The uptake of 18F-G1 in kidney will be quantitatively assessed by SUVmax. - the granzyme B specificity of 18F-G1 — 3 years
- Assessing the early predictive value of 18F-G1 PET/CT for immunotherapy response. — 6 months
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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Peking University First Hospital | Beijing | China | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07039474 on ClinicalTrials.gov ↗ ← All trials in China