99mTc-3PRGD2 SPECT/CT for Integrin Imaging of Lung Cancer
- Conditions
- Lung CancerLymph Node Metastasis
- Interventions
- Drug: 99mTc-3PRGD2 injection
- Registration Number
- NCT04233476
- Lead Sponsor
- RDO Pharm.
- Brief Summary
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.
- Detailed Description
Accurate evaluation of lymph node metastasis plays a pivotal role in optimizing the surgical intervention and other precision treatments for lung cancer. CT-based nodal staging of lung cancer has limitation due to its low sensitivity, which relies on variations in tumor's size and structure. 18F-FDG PET/CT demonstrates low specificity owing to the nonspecific uptake in inflammatory lymph nodes, typically necessitating additional invasive mediastinal staging. Integrin αVβ3-targeted imaging could potentially bridge this existing technical gap. As a member of integrin family, integrin αVβ3 plays a crucial role in mediating tumor formation, invasion, metastasis, and angiogenesis. Therefore, integrin αVβ3 is an attractive target for tumor diagnosis and therapy. However, as of today, no drug has been approved for either diagnosis or therapy by targeting integrin αVβ3.
A diagnostic drug targeting integrin αvβ3, technetium-99m \[99mTc\] labeled hydrazinonicotinamide-PEG4-E\[PEG4-c(RGDfk)\]2 (99mTc-3PRGD2), has been developed for imaging of lung cancer and other tumors via single photon emission computed tomography/ X-ray computed tomography (SPECT/CT). After intravenous injection into the body, 99mTc-3PRGD2 is expected to be specifically taken up by integrin αVβ3-positive tumors. The images obtained by SPECT/CT will be used for diagnosis and evaluation of the tumors, thereby guiding the individualized treatments including surgical intervention.
A prospective, multicenter, self-controlled phase 3 clinical trial is designed to evaluate the safety and efficacy of an integrin αVβ3-targeted imaging, 99mTc-3PRGD2 SPECT/CT, for diagnosis of lung cancer, with mapping the lymph node metastases as the primary objective. 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. 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.
More than 400 patients with suspected lung cancer are designed to be recruited from 11 medical centers. Participants who meet the inclusion and exclusion criteria will be recruited to undergo SPECT/CT planar scan and chest tomography after intravenous injection of 99mTc-3PRGD2 at a dose of 0.3 mCi/kg. They will also undergo 18F-FDG PET/CT within a week. Among them, the patients who successfully complete safety tests are included into the safety analysis set.
At least 270 participants are expected to undergo lung lobectomy and lymph node station resection within 2 weeks after the 99mTc-3PRGD2 SPECT/CT. Their pathological results will be collected and used as the gold standard to evaluate the diagnostic efficacy of 99mTc-3PRGD2 SPECT/CT for diagnosis of lung tumors and lymph node metastases, with a head-to-head comparison with 18F-FDG PET/CT. Those patients who undergo lung surgery and lymph node resection within two weeks after the 99mTc-3PRGD2 SPECT/CT will be included into the efficacy analysis set to evaluate the efficacy of the imaging method in diagnosis of lung cancer and mapping the lymph node metastases.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 409
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 99mTc-3PRGD2 injection for SPECT/CT imaging, with 18F-FDG PET/CT for head-to-head comparison. 99mTc-3PRGD2 injection Participants will receive a single-dose intravenous injection of 99mTc-3PRGD2 at a dosage of approximate 11.10 MBq (0.30 mCi) per kilogram body weight. Whole-body planar scan and chest SPECT/CT imaging will be performed 40-50 min later. Chest low-dose spiral CT (120 kV, 50 mAs) will be used for attenuation correction and anatomical localization. The conventional metabolic imaging by 18F-FDG PET/CT of the same patients within one week will be used for a self-controlled head-to-head comparison.
- Primary Outcome Measures
Name Time Method Evaluate whether the diagnostic specicity of 99mTc-3PRGD2 SPECT/CT is superior to that of 18F-FDG PET/CT in mapping lymph node metastasis of lung cancer in the same group of patients. From the informed consent of the first participant to 2 weeks after the intervention of the last participants or until the last participant accepted surgery within 2 weeks Using the pathological results as the gold standard, calculate the specificity of 99mTc-3PRGD2 SPECT/CT in mapping of lymph node metastasis of lung cancer according to the nodal mapping system released by the International Association for the Study of Lung Cancer in 2009 (IASLC-2009), and compared it head-by-head with that of the conventional metabolic imaging by 18F-FDG PET/CT in the same group of patients. And then assess if the specificity of 99mTc-3PRGD2 SPECT/CT is superior to that of 18F-FDG PET/CT.
- Secondary Outcome Measures
Name Time Method Diagnostic accuracy, sensitivity, positive predictive value and negative predicive value of 99mTc-3PRGD2 SPECT/CT in mapping lymph node metastasis of lung cancer, with a head-to-head comparison to 18F-FDG PET/CT. From the informed consent of the first participant to 2 weeks after the intervention of the last participants or until the last participant accepted surgery within 2 weeks Evaluate the diagnostic accuracy, sensitivity, positive predictive value and negative predicive value of 99mTc-3PRGD2 SPECT/CT in mapping of lymph node metastasis of lung cancer according to the nodal mapping system released by the IASLC-2009. 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.
Incidence of adverse events for safety evaluation of 99mTc-3PRGD2 injection and SPECT/CT imaging in human beings From the informed consent of the first participant to 2 weeks after the intervention of the last participants or until the last participant accepted surgery within 2 weeks Number of participants with adverse events, including treatment-emergent abnormality in vital sign measurements, physical examinations, 12-lead electrocardiogram report, or clinical laboratory tests (routine blood tests, blood biochemical tests, routine urine tests, etc). The relevant adverse reactions emerged during the study will be questioned or examined, and then recorded in detail to evaluate the safety of 99mTc-3PRGD2 SPECT/CT in the participants.
Efficacy of 99mTc-3PRGD2 SPECT/CT in diagnosis of lung cancer, with a head-to-head comparison to 18F-FDG PET/CT. From the informed consent of the first participant to 2 weeks after the intervention of the last participants or until the last participant accepted surgery within 2 weeks With the pathological diagnoses as the gold standard, the diagnostic values of 99mTc 3PRGD2 SPECT/CT will be obtained and the conventional metabolic imaging by 18F-FDG PET/CT will be used for a head-to-head comparison.
Trial Locations
- Locations (11)
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China
West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China
Peking University Cancer Hospital & Institute
🇨🇳Beijing, Beijing, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Shengjing Hospital of China Medical University
🇨🇳Shengyang, Liaoning, China
The First Affiliated Hospital of Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
China-Japan Union Hospital of Jilin University
🇨🇳Changchun, Jilin, China
The Affiliated Hospital of Inner Mongolia Medical University
🇨🇳Hohhot, Inner Mongolia Autonomous Region, China
Renji Hospital of Shanghai Jiao Tong University
🇨🇳Shanghai, Shanghai, China
First Hospital of Shanxi Medical Universit
🇨🇳Taiyuan, Shanxi, China