TheranosticTrials.org

Clinical Trial · NCT04233476

99mTc-3PRGD2 SPECT/CT for Integrin Imaging of Lung Cancer

Overview

This is a prospective, multicenter, self-controlled phase 3 clinical trial designed to evaluate the safety and efficacy of an integrin αVβ3-targeted imaging, 99mTc-3PRGD2 SPECT/CT, for diagnosis of lung cancer and mapping the lymph node metastases. The pathological results will be considered as the gold standard and the conventional metabolic imaging by 18F-FDG PET/CT will be used for a head-to-head comparison. The primary objective of this study is to evaluate the efficacy of 99mTc-3PRGD2 SPECT/CT in mapping of lymph node metastasis according to the nodal mapping system released by the International Association for the Study of Lung Cancer in 2009 (IASLC-2009). The secondary objectives include evaluation of 99mTc-3PRGD2 SPECT/CT in detection of lung cancer and the safety of 99mTc-3PRGD2 injection in human beings.

Sponsor

Var2 Pharmaceuticals

Phase

Phase 3

Contacts

Zhaohui Zhu, MD, PhD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT04233476

Drug / Compound

3PRGD2

Isotope(s):
Target(s):
  • αvβ3
Ligand Class: Peptides
Chelator: hydrazinonicotinamide
Linker: PEG4

FDG

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

Eligibility

Inclusion

  • Female patients who plan of pregnant within 6 months, or in pregnant or lactating;
  • Willing and be able to follow scheduled visits, treatment plans, and laboratory tests;
  • Diagnostic CT shows that the longest diameter of the tumor occupying the lung is ≥1.5 cm and the shortest diameter is ≥1.0 cm;
  • Contrast-enhanced CT examination shows ground-glass nodules without solid components;
  • Body weight exceeds 100 kg;
  • Those who are currently participating in another clinical trial or have participated in other clinical trials within the past 3 month.
  • Before injecting 18F-FDG, the fasting blood glucose level exceeds 7.0 mmol/L (tested by rapid blood glucose meter);
  • Clinical laboratory examination and other indicators are within the normal range or abnormal but do not affect related examinations and treatments.Exclusion criteriaPatients who have any of the following are not eligible for enrollment:
  • With claustrophobia;
  • Cannot tolerate raising their arms and lying on the scanner bed for 15-30 min;
  • Inclusion criteriaParticipants must meet all of the following inclusion criteria to be eligible for this study:
  • 18F-FDG PET/CT examination shows tumor occupancy in the lungs, with positive hilar and/or mediastinal lymph nodes on either enhanced CT or 18F-FDG PET/CT;
  • Those the investigator believes not suitable to participate in this clinical trial;
  • Allergic to the test drugs, have allergic constitution, or are allergic to multiple drugs;

Exclusion

Exclusion criteria not yet provided.