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IRCT20220817055732N1 IRCT 2022-09-26 Shahid Beheshti University of Medical Sciences Evaluation of 68Ga-FAPI radiotracer in lung cancer Evaluation of the diagnostic value of 68Ga-FAPI radiotracer compared with 18F-FDG in PET/CT scans of patients with non-small cell lung cancer- a pilot study 2022-10-23 anticipated 20 Complete https://irct.ir/trial/65361 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Diagnostic. 2 Lung cancer. Intervention 1: Intervention group: patients with lung cancer referred to this center after 18F-FDG are selected non-randomly after receiving full explanations and personal consent to perform a second diagnostic scan with 68Ga-FAPI radiotracer produced by Pars Isotope Company. 68Ga-FAPI scan with a dose of about 2 MB/kg of the patient's weight is performed at a maximum interval of one month after the 18FDG scan. After the injection of the radiopharmaceutical, the patient waits for one hour until the radiopharmaceutical be absorbed in the target tissues. After that, the scan of the mid-thigh is performed with a PET-CT Discovery 690 VCT device from GE Healthcare equipped with CT 64 slice for 30 minutes. Data obtained from PET-CT imaging are reconstructed using a standard algorithm with attenuation correction based on CT scan data. During this interval between two scans, the patient will not receive any medical intervention. Intervention 2: Control group: I patients with lung cancer refered to the Nuclear Medicine Center of Masih Daneshvari Hospital for a diagnostic PET-CT scan. 18FDG scan with 18FDG radiopharmaceutical produced in the cyclotron department of this hospital is performed according to the international standard protocol. 68Ga-FAPI scan with a dose of about 2 MB/kg of the patient's weight is performed at a maximum interval of one month after the 18FDG scan. After the injection of the radiopharmaceutical with a dose 4.6 Megabecquerel (MBq) per kilogram , the patient waits for one hour until the radiopharmaceutical be absorbed in the target tissues. After that, the scan of the mid-thigh is performed with a PET-CT Discovery 690 VCT device from GE Healthcare equipped with CT 64 slice for 30 minutes. Data obtained from PET-CT imaging are reconstructed using a standard algorithm with attenuation correction based on CT scan data. Yes - There is a plan to make this available What will be shared: 1. The statistical data obtained from the comparison of 18FDG and 68Ga-FAPI scans, which show their diagnostic value in finding primary active lesions of lung cancer. 2. Comparative PET-CT scan images with 18FDG and 68Ga-FAPI radiotracers obtained from patients 3. Study protocol 4. Basic characteristics of patients When: The end of study To whom: Nuclear Medicine - Nuclear Pharmacy - Oncologist - Companies producing radiopharmaceuticals Conditions: 1. The obtained data may be used for further evaluation of 18Ga-FAPI radiopharmaceutical in other tumor lesions or other diseases. 2. The obtained clinical data may be used to register 18Ga-FAPI radiotracer as a new diagnostic radiopharmaceutical in lung cancer. Where to obtain: 1. Dr Abtin Drudinia- Nuclear Medicine center of Masih Danehvari hospital- abtin1354@gmail.com 2. Dr Hossein Behnammanesh- Nuclear Medicine center of Masih Danehvari hospital- h_behnam@sbmu.ac.ir How to obtain: After the end of the project, the obtained data will be published in related scientific journals and will be available in this way. Comments:
public hossein behnam-manesh
masih daneshvari hospital, daar-abad, niavaran
tehran Iran (Islamic Republic of) 1956944413 +98 21 2712 2701 h_behnam@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Abtin Doroudinia
masih daneshvari hospital, daar-abad, niavaran
tehran Iran (Islamic Republic of) 19569-44413 +98 21 2712 2706 abtin1354@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) A patient with lung cancer proven in pathology A patient with lung cancer in the staging phase no limit no limit Both Patients do not accept the offer of PET-CT with 68Ga-FAPI radiopharmaceutical after providing the necessary explanations and answering their questions. Patients withdraw from the study before the scan. Uncontrolled diseases (such as fatal arrhythmias) that require hospitalization. Suffering from mental illnesses that take away the ability to make decisions and cooperate. Pregnant or lactating women. Suffering from physical diseases that disrupt the imaging process. The death of the patient in the interval between the two studied scans. History of cancer other than lung cancer History of active inflammatory/infectious disease C34 Malignant neoplasm of bronchus and lung Diagnosis Diagnosis Intervention group: patients with lung cancer referred to this center after 18F-FDG are selected non-randomly after receiving full explanations and personal consent to perform a second diagnostic scan with 68Ga-FAPI radiotracer produced by Pars Isotope Company. 68Ga-FAPI scan with a dose of about 2 MB/kg of the patient's weight is performed at a maximum interval of one month after the 18FDG scan. After the injection of the radiopharmaceutical, the patient waits for one hour until the radiopharmaceutical be absorbed in the target tissues. After that, the scan of the mid-thigh is performed with a PET-CT Discovery 690 VCT device from GE Healthcare equipped with CT 64 slice for 30 minutes. Data obtained from PET-CT imaging are reconstructed using a standard algorithm with attenuation correction based on CT scan data. During this interval between two scans, the patient will not receive any medical intervention. Control group: I patients with lung cancer refered to the Nuclear Medicine Center of Masih Daneshvari Hospital for a diagnostic PET-CT scan. 18FDG scan with 18FDG radiopharmaceutical produced in the cyclotron department of this hospital is performed according to the international standard protocol. 68Ga-FAPI scan with a dose of about 2 MB/kg of the patient's weight is performed at a maximum interval of one month after the 18FDG scan. After the injection of the radiopharmaceutical with a dose 4.6 Megabecquerel (MBq) per kilogram , the patient waits for one hour until the radiopharmaceutical be absorbed in the target tissues. After that, the scan of the mid-thigh is performed with a PET-CT Discovery 690 VCT device from GE Healthcare equipped with CT 64 slice for 30 minutes. Data obtained from PET-CT imaging are reconstructed using a standard algorithm with attenuation correction based on CT scan data. The number of malignant lesions in selected patients. Timepoint: After PET-CT imaging of the patients with 18FDG and 68Ga-FAPI radiotracers. Method of measurement: Investigation of PET-CT scans. Localization of malignant lesions in selected patients. Timepoint: After PET-CT imaging of the patients with 18FDG and 68Ga-FAPI radiotracers. Method of measurement: Investigation of PET-CT scans. Size of malignant lesions in selected patients. Timepoint: After PET-CT imaging of the patients with 18FDG and 68Ga-FAPI radiotracers. Method of measurement: Investigation of PET-CT scans. Shape of malignant lesions in selected patients. Timepoint: After PET-CT imaging of the patients with 18FDG and 68Ga-FAPI radiotracers. Method of measurement: Investigation of PET-CT scans. Shahid Beheshti University of Medical Sciences Approved 2022-08-17 Ethics committee of Shahid Beheshti University of Medical Sciences 7th Floor, Bldg No.2, SBMU, Velenjak Tehran Tehran Iran (Islamic Republic of)