Positron Nuclide Labeled NOTA-FAPI PET Study in Lymphoma

Peking University Cancer Hospital & Institute

Status: Unknown

Conditions: Lymphoma; Tumor, Solid; Positron-Emission Tomography

Treatments: Diagnostic Test: 18F-FDG and 68Ga-NOTA-FAPI04 PET/CT; Diagnostic Test: 18F-FDG and 18F-NOTA-FAPI04 PET/CT

Study type: Interventional

Funder types: Other

Identifiers

NCT04367948

XW-FAPI-001

Details and patient eligibility

About

To evaluate the normal physiological distribution of positron nuclide labeled NOTA-F API in human body and its detection efficiency for lymphoma

Full description

Subjects first undergo an 18F-FDG test, followed by 68Ga-NOTA-FAPI04 or 18F-NOTA-FAPI04 test in groups.Investigate the standardized uptake value(SUV) of 68Ga/ 18F-NOTA-FAPI04 for the target lesion, the ratio of the standardized uptake value(SUVR) of 68Ga/ 18F-NOTA-FAPI04 for the target lesion within each time window to that of the normal corresponding tissue.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ECOG score 0 or 1
• subjects with lymphoma or suspected tumor subjects who have recently (within 2 months) planned to receive pathological biopsy or tumor surgery
• expected survival ≥12 weeks
• blood routine, liver and kidney function meet the following criteria: blood routine: WBC≥4.0×109L or neutrophils ≥1.5×109L, PLT≥100×109/L, Hb≥90g/L;PT and APTT ULN 1.5 or less;Liver and kidney function: t-bil ≤1.5×ULT(upper limit of normal value), ALT/AST≤2.5ULN or ≤5×ULT(subjects with liver metastasis), ALP≤2.5ULN(ALP≤ 4.5ULN if there is bone metastasis or liver metastasis);BUN 1.5 x or less ULT, SCr 1.5 x or less ULT
• at least one measurable target lesion according to RECIST1.1
• women must use effective contraception during the study period and for 6 months after the end of the study (effective contraception means sterilization, hormone devices, condoms, contraceptives/pills, abstinence or vasectomy by a partner, etc.);Men should consent to subjects who must use contraception during the study period and for 6 months after the end of the study period
• able to understand and sign the informed consent voluntarily, with good compliance.

Exclusion criteria

• severe abnormalities of liver and kidney function;
• women preparing for pregnancy, pregnancy and lactation;
• cannot lie supine for half an hour;
• refuse to join the clinical researcher;
• suffering from claustrophobia or other mental illness;
• conditions that other researchers considered inappropriate for the study.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

68Ga-NOTA-FAPI04

Experimental group

Description:

Each subject receive a single intravenous injection of 18F-FDG and 68Ga-NOTA-FAPI04, and undergo PET/CT imaging within the specified time

Treatment:

Diagnostic Test: 18F-FDG and 68Ga-NOTA-FAPI04 PET/CT

18F-NOTA-FAPI04

Experimental group

Description:

Each subject receive a single intravenous injection of 18F-FDG and 18F-NOTA-FAPI04, and undergo PET/CT imaging within the specified time

Treatment:

Diagnostic Test: 18F-FDG and 18F-NOTA-FAPI04 PET/CT