Clinical trial NCT04367948: Positron Nuclide Labeled NOTA-FAPI PET Study in Lymphoma
Official title: Positron Nuclide Labeled NOTA-FAPI PET Study in Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tumor, Solid
Positron-Emission Tomography
Lymphoma
Keywords: Lymphoma
Positron-Emission Tomography
FAPI
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: SUV
timeFrame: 60 days
Secondary outcomes:
measure: SUVR
timeFrame: 60 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital
state: Beijing
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Zhi Yang, PhD
role: STUDY_DIRECTOR
References:
citation: Wang G, Jin X, Zhu H, Wang S, Ding J, Zhang Y, Yang Z, Wang X. 68Ga-NOTA-FAPI-04 PET/CT in a patient with primary gastric diffuse large B cell lymphoma: comparisons with [18F] FDG PET/CT. Eur J Nucl Med Mol Imaging. 2021 Feb;48(2):647-648. doi: 10.1007/s00259-020-04946-0. Epub 2020 Jul 6. No abstract available.