Lung Cancer Metastatic Clinical Trial
Official title:
An Evaluation of the Efficacy and Safety of Technetium [99mTc] Hydrazinonicotinamide PEGylated Bicyclic RGD Peptide Injection in a Multicenter, Open, Self-controlled Clinical Trial for the Lymph Node Metastasis in Lung Tumors
The study drug Technetium [99mTc] Hydrazinonicotinamide PEGylated Bicyclic RGD Peptide Injection(99mTc-3PRGD2) of this study is a novel radioactive diagnostic preparation for clinical use as a nuclear medicine molecular probe for tumor SPECT/CT imaging. After 99mTc-3PRGD2 is injected into the body, it is specifically taken up by integrin receptor-positive tumor tissue, and the image of tumor tissue can be obtained by SPECT/CT, This can be used for molecular imaging diagnosis and individualized treatment of common tumors. The primary objective of this study was to evaluate the efficacy of 99mTc-3PRGD2 for the diagnosis of lymph node metastasis in lung tumors. The minor objective was to evaluate the efficacy of 99mTc-3PRGD2 in the differential diagnosis of benign and malignant lung tumors and the safety of 99mTc-3PRGD2 in vivo of humans.
This study strictly obeyed to the result by pathological diagnoses standard. The evaluation of the efficacy of 99mTc-3PRGD2 in the diagnosis of lymph node metastasis of lung tumors is based on a multi-center, open, self-controlled clinical trial. This study involves 10 research sites and a total of about 400 qualified patients who met the protocol requirements in China, besides, they were previously diagnosed by 18F FDG PET / CT with positive results in pulmonary occupying and lymph nodes (hilar or mediastinum) uptake. At least 270 participants' surgical pathology report were required. After screening the patients, the intravenous injection of 99mTc-3PRGD2 with a dose of 0.3 mCi / kg was performed, followed by SPECT / CT plain scan and chest tomography scan. The doctors are responsible for patients about whether they should take lymphadenectomy and obtain the surgical pathology reports. At the same time, the safety of 99mTc-3PRGD2 injection in human body was evaluated. This study strictly obeyed to the result by pathological diagnoses standard which uses the four-grid table to calculate the accuracy, sensitivity and specificity of 99mTc-3PRGD2 SPECT/CT diagnosis. Besides, the diagnostic results of 18F-FDG Positron Emission computed Tomography/Chest Tomography (PET/CT) were compared to evaluate the effectiveness of 99mTc-3PRGD2 SPECT/CT in the diagnosis of lymph node metastasis and differential diagnosis of benign and malignant lung tumors as well as evaluate the safety of 99mTc-3PRGD2 injection in vivo of humans. This study invited an independent imaging evaluation committee to evaluate images obtained with 18F-FDG PET/CT, 99mTc-3PRGD2 SPECT/CT and enhanced CT. Study duration: The start of the study is defined as the date on which the first participant signed the Informed Consent Form (ICF); the End Of the Study (EOS) was defined as the end of the collection of the final participant safety assessment data. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05452005 -
Fluorine-18-AlphaVBeta6-Binding Peptide Positron Emission Tomography in Metastatic Non-Small Cell Lung Cancer
|
Phase 1 | |
Completed |
NCT03179150 -
Clinical Validation of the M5L Lung CAD
|
N/A | |
Recruiting |
NCT03693339 -
Capmatinib in Patients With Non-small Cell Lung Cancer Harboring cMET exon14 Skipping Mutation
|
Phase 2 | |
Completed |
NCT03970564 -
Neck Ultrasound by Respiratory Physicians in Patients With Lung Cancer
|
||
Completed |
NCT03184571 -
Bemcentinib (BGB324) in Combination With Pembrolizumab in Patients With Advanced NSCLC
|
Phase 2 | |
Terminated |
NCT02308865 -
Early Palliative Care in Metastatic Lung Cancer in Northern France
|
N/A | |
Not yet recruiting |
NCT03703596 -
Anlotinib Versus Docetaxel as the Second-line Treatment in EGFR Wild Type Patients With Advanced NSCLC
|
Phase 2 | |
Terminated |
NCT04069936 -
Marrow Infiltrating Lymphocytes - Non-Small Cell Lung Cancer (MILs™ - NSCLC) Alone or in Combination With Nivolumab With or Without Tadalafil in Locally Advanced and Unresectable or Metastatic NSCLC
|
Phase 2 | |
Recruiting |
NCT05537922 -
I3LUNG: Integrative Science, Intelligent Data Platform for Individualized LUNG Cancer Care With Immunotherapy
|
||
Active, not recruiting |
NCT04986670 -
NutriCare Plus a Medically Tailored Meal Intervention Among Patients With Lung Cancer
|
N/A | |
Completed |
NCT03755102 -
A Pilot Study of Dacomitinib With or Without Osimertinib for Patients With Metastatic EGFR Mutant Lung Cancers With Disease Progression on Osimertinib.
|
Early Phase 1 | |
Not yet recruiting |
NCT03638765 -
Dendritic Cell Therapy for Brain Metastases From Breast- or Lung Cancer
|
Phase 1 | |
Recruiting |
NCT02976740 -
SBRT Combination With rhGM-CSF and Tα1 for Stage IV NSCLC Patients Who Failed in Second-line Chemotherapy
|
Phase 2 | |
Active, not recruiting |
NCT04085315 -
Alisertib in Combination With Osimertinib in Metastatic EGFR-mutant Lung Cancer
|
Phase 1 | |
Recruiting |
NCT03693326 -
PDR001 in Patients With Non-small Cell Lung Cancer Harboring KRAS/NRAS Mutation or no Actionable Genetic Abnormalities
|
Phase 2 | |
Recruiting |
NCT05860296 -
Testing Experimental Anti-cancer Drug SLC-391 With an Approved Immunotherapy Drug, Pembrolizumab, for Advanced Lung Cancers
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04964960 -
Pembro+Chemo in Brain Mets
|
Phase 2 | |
Active, not recruiting |
NCT04973436 -
DBT for Metastatic Lung Cancer
|
N/A | |
Recruiting |
NCT05078047 -
Study Comparing the Standard Administration of IO Versus the Same IO Administered Each 3 Months in Patients With Metastatic Cancer in Response After 6 Months of Standard IO
|
Phase 3 | |
Active, not recruiting |
NCT03057106 -
Durvalumab and Tremelimumab ± Platinum-Based Chemotherapy in Patients With Metastatic Squamous or Non-Squamous NSCLC
|
Phase 2 |