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

NCT ID: NCT07039474

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-15
• Study Completion Date: 2027-06-01

Brief 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

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.

Conditions

Solid Tumors and Hematological Tumors

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

18F-G1

18F-G1 is injected intravenously with a dose of 0.06-0.08mCi/kg

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Peking University First Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Caixia Wu

Role: CONTACT

wucaixia314@163.com

010-83575252

Other Identifiers

2025R0069

Identifier Type: -

Identifier Source: org_study_id