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IRCT20210612051548N5 IRCT 2022-01-29 Boushehr University of Medical Sciences Diagnostic efficacy of 99mTc-FAPI SPECT/CT Evaluation the efficiency of 99mTc-FAPI radiotracer in diagnosis of patients suffering from cancer 2022-03-06 anticipated 15 Complete https://irct.ir/trial/60352 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Diagnostic. 1 Malignant neoplasm. Intervention group: The majority of epithelial tumors recruit fibroblasts and other non‐malignant cells and activate them into cancer‐associated fibroblasts. This often leads to overexpression of the membrane serine protease fibroblast‐activating protein (FAP). It has already been shown that DOTA‐bearing FAP inhibitors (FAPIs) generate high contrast images with PET/CT scans. Since SPECT is a lower cost and more widely available alternative to PET, 99mTc‐labeled FAPIs represent attractive tracers for imaging applications in a larger number of patients. In this clinical trial, 740 MBq of the 99mTc-FAPI will be injected intravenously. Then, SPECT/CT will be performed at 1 and 4 h after tracer administration of radiotracer.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is no more information
public Majid Assadi
The Khalij-e-Fars Nuclear Medicine Research Center, Bushehr University of Medical Sciences,Moallem Street, Bushehr, Iran
Bushehr Iran (Islamic Republic of) 45654775 +98 77 3332 0361 assadipoya@yahoo.com Boushehr University of Medical Sciences scientific Majid Assadi
The Khalij-e-Fars Nuclear Medicine Research Center, Bushehr University of Medical Sciences,Moallem Street, Bushehr, Iran
Bushehr Iran (Islamic Republic of) 45654775 +98 77 3332 0361 assadipoya@yahoo.com Boushehr University of Medical Sciences Iran (Islamic Republic of) Volunteering to participate in clinical trials and signing an informed consent form (signed by participant, parent, or legal representative) Patients with suspected or new diagnosed or previously treated malignant tumors Inconclusive findings on imaging modalities. 18 years no limit Both Pregnant and lactating women The inability or unwillingness of the research participant, parent, or legal representative to provide written informed consent C00-C96 Malignant neoplasm Diagnosis Intervention group: The majority of epithelial tumors recruit fibroblasts and other non‐malignant cells and activate them into cancer‐associated fibroblasts. This often leads to overexpression of the membrane serine protease fibroblast‐activating protein (FAP). It has already been shown that DOTA‐bearing FAP inhibitors (FAPIs) generate high contrast images with PET/CT scans. Since SPECT is a lower cost and more widely available alternative to PET, 99mTc‐labeled FAPIs represent attractive tracers for imaging applications in a larger number of patients. In this clinical trial, 740 MBq of the 99mTc-FAPI will be injected intravenously. Then, SPECT/CT will be performed at 1 and 4 h after tracer administration of radiotracer. Target/Background ratio of 99mTc-FAPI SPECT/CT in Diagnosis of malignancies. Timepoint: 99mTc-FAPI Imaging at 1and 4 hours after the administration of the Radiotracer. Method of measurement: SPECT/CT scanner. Boushehr University of Medical Sciences Approved 2021-06-27 Research Ethics Committees of Bushehr University of Medical Sciences Bushehr University of Medical Science, Moallem Street Bushehr Boushehr Iran (Islamic Republic of)