The Application of 18F-G1 PET/CT Targeting Granzyme B in the Pan-cancer Immunotherapy

Peking University

Status: Not yet enrolling

Conditions: Solid Tumors and Hematological Tumors

Treatments: Drug: 18F-G1

Study type: Observational

Funder types: Other

Identifiers

NCT07039474

2025R0069

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.