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IRCT20180818040823N2 IRCT 2020-12-23 Tehran University of Medical Sciences Application of labeled trastuzumab to diagnose breast cancer in HER2 positive cases A clinical trial of a diagnostic radiopharmaceutical (64Cu-DOTA-Trastuzumab) in patients with metastatic breast cancer and HER2-positive 2021-01-20 anticipated 22 Complete https://irct.ir/trial/51353 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Diagnostic. 2 Metastatic breast cancer. Intervention group: In this study, 5 mg of 64Cu-DOTA-trastuzumab radiopharmaceutical with a dose of 500-300 MB / h MBq, is injected into 22 patients with metastatic breast cancer and HER2 receptor. Then PET imaging is performed in 3 intervals, 1 h, 24 h day, and 48 h after injection. The drug is supplied by Pars Isotope Company.. Yes - There is a plan to make this available What will be shared: The sharable data are de-identified images of patients with this new diagnostic method and performed quantitative and qualitative analyzes When: The access period will start 6 months after the results are published To whom: Both academics and non-faculty medical staff will be able to use it. Conditions: The de-identified images of the patients will be available by email to the principal investigator and can be applied by those who need access. Where to obtain: For more images and data than what has been published as an article, applicants can contact the principal researcher via email. How to obtain: An initial response will be given up to 24 hours later after sending the email, and according to the type of applied information, the applicant will be provided with the applied data for up to 1 month. Comments:
public Mehrshad Abbasi
Nuclear Medicine Department, Imam Khomeini Hospital Complex, Dr. Qarib street, Keshavarz boulevard
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6657 5102 meabbasi@tums.ac.ir Tehran University of Medical Sciences scientific Mehrshad Abbasi
Nuclear Medicine Department, Imam Khomeini Hospital Complex, Dr. Qarib street, Keshavarz boulevard
Tehran Iran (Islamic Republic of) 1419733141 002166575102 meabbasi@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patient with metastatic breast cancer and HER2 receptor stage 4 No previous treatment with Herceptin Negative estrogen and progesterone receptors 18 years no limit Female C50 Malignant neoplasm of breast Diagnosis Intervention group: In this study, 5 mg of 64Cu-DOTA-trastuzumab radiopharmaceutical with a dose of 500-300 MB / h MBq, is injected into 22 patients with metastatic breast cancer and HER2 receptor. Then PET imaging is performed in 3 intervals, 1 h, 24 h day, and 48 h after injection. The drug is supplied by Pars Isotope Company. Uptake of radiopharmaceutical in lesions. Timepoint: At imaging time (60 minutes after injection). Method of measurement: Observation and semi-quantification using SUV. Tehran University of Medical Sciences Approved 2020-01-14 Tehran University of Medical Science Research office, 1st floor, block NO1 of medical science faculty, Poorsina St , Qods St, Enghelab Sq. Tehran Tehran Iran (Islamic Republic of)