Positron Nuclide Labeled NOTA-FAPI PET Study in Lymphoma

Not Applicable

• Conditions: Lymphoma; Tumor, Solid; Positron-Emission Tomography
• Interventions: Diagnostic Test: 18F-FDG and 18F-NOTA-FAPI04 PET/CT; Diagnostic Test: 18F-FDG and 68Ga-NOTA-FAPI04 PET/CT

• Registration Number: NCT04367948
• Lead Sponsor: Peking University Cancer Hospital & Institute

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2020-04
• Study First Submitted: 2020-04-26
• Study First Submitted QC: 2020-04-26
• Last Update Submitted: 2020-04-26
• Study First Posted: 2020-04-29
• Last Update Posted: 2020-04-29
• Study Start: 2020-05-01
• Primary Completion: 2021-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
SUV	60 days	Standardized uptake value of 68Ga/ 18f-nota-fapi04 for target lesion of subject or suspected tumor in each time point window (SUV)

Secondary Outcome Measures

Name	Time	Method
SUVR	60 days	the ratio of the standardized uptake value(SUVR) of 68Ga/ 18f-nota-fapi04 for the target lesion or suspected tumor lesion within each time window to that of the normal tissue corresponding to the tumor lesion or suspected tumor lesion to the standardized uptake value of 68Ga/ 18f-nota-fapi04

Trial Locations

Locations (1)

Peking University Cancer Hospital; 🇨🇳 Beijing, Beijing, China