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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorPeking University First Hospital

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Subjects diagnosed with a malignant tumor (solid tumor or hematological tumor) by histopathology who are going to receive immunotherapy (monotherapy or combined immunotherapy).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 18F-G1

    Drug

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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
3 days after the injection of 18F-G1
2

Tumor uptake of 18F-G1

The uptake of 18F-G1 in tumors will be quantitatively assessed by SUVmax.

Time frame
40-60 minutes after the injection of 18F-G1
3

Liver uptake of 18F-G1

The uptake of 18F-G1 in liver will be quantitatively assessed by SUVmax.

Time frame
40-60 minutes after the injection of 18F-G1
4

Lung uptake of 18F-G1

The uptake of 18F-G1 in lung will be quantitatively assessed by SUVmax.

Time frame
40-60 minutes after the injection of 18F-G1

Secondary outcomes

1

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.

Time frame
3 years

Other outcomes

Sponsors and contacts

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