TheranosticTrials.org

Clinical Trial · NCT04367948

Positron Nuclide Labeled NOTA-FAPI PET Study in Lymphoma

Overview

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

Sponsor

Peking University Cancer Hospital & Institute

Phase

N/A

Contacts

Zhi Yang, PhD (STUDY_DIRECTOR)

Xuejuan Wang, MD (CONTACT)

xuejuan_wang@hotmail.com

86 010 88196363

ClinicalTrials.gov

NCT04367948

Drug / Compound

NOTA-FAPI04

Isotope(s):
Target(s):
  • FAP
Ligand Class: Small Molecules
Chelator: NOTA

FDG

Isotope(s):
Target(s):
  • Glucose Transport
Ligand Class: Small Molecules

Eligibility

Inclusion

  • at least one measurable target lesion according to RECIST1.1
  • ECOG score 0 or 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
  • 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
  • expected survival ≥12 weeks
  • subjects with lymphoma or suspected tumor subjects who have recently (within 2 months) planned to receive pathological biopsy or tumor surgery

Exclusion

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