Safety and Efficacy of 99mTc-hydrazinonicotinamide-PEG4-E[PEG4-c(RGDfk)]2 (99mTc-3PRGD2) for Integrin αVβ3 SPECT/CT Imaging of Lung Cancer and Mapping Lymph Node Metastases: A Prospective Multicenter, Self-controlled, Phase 3 Trial

FSRDA201901

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.

2019-10-12

2021-05-08

2021-05-08

Completed

Early phase I

409

Inclusion criteria Participants must meet all of the following inclusion criteria to be eligible for this study: 1. Voluntarily participate and sign the Informed Consent Form; 2. Age ≥18 years old; 3. 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; 4. 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; 5. Willing and be able to follow scheduled visits, treatment plans, and laboratory tests; 6. Clinical laboratory examination and other indicators are within the normal range or abnormal but do not affect related examinations and treatments. Exclusion criteria Patients who have any of the following are not eligible for enrollment: 1. Female patients who plan of pregnant within 6 months, or in pregnant or lactating; 2. Allergic to the test drugs, have allergic constitution, or are allergic to multiple drugs; 3. Contrast-enhanced CT examination shows ground-glass nodules without solid components; 4. Before injecting 18F-FDG, the fasting blood glucose level exceeds 7.0 mmol/L (tested by rapid blood glucose meter); 5. Body weight exceeds 100 kg; 6. With claustrophobia; 7. Cannot tolerate raising their arms and lying on the scanner bed for 15-30 min; 8. Those the investigator believes not suitable to participate in this clinical trial; 9. Those who are currently participating in another clinical trial or have participated in other clinical trials within the past 3 month.

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2024-06-17