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IRCT20210612051548N3 IRCT 2021-10-18 Boushehr University of Medical Sciences Endoradiotherapy with 177Lu-Trastuzumab in patients with HER2-positive breast cancer The efficiency of endoradiotherapy with 177Lu-Trastuzumab in patients with resistant or relapsed HER2-positive breast cancer 2022-01-21 anticipated 15 Complete https://irct.ir/trial/59122 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 Malignant breast cancer. Intervention group: In this study, the 177Lu-Trastuzumab PET/CT radiopharmaceutical is injected intravenously into 15 patients with breast cancers according to the 68Ga-Trastuzumab PET/CT. Then whole-body scan is performed at 24 hours, and 48 hours after injection to assess radiotracer distribution. Six to eight weeks after the 177Lu-Trastuzumab PET/CT therapy, the patients will be visited by oncologists and nuclear medicine physicians and if there was not any toxicity, the next treatment session will be performed.. 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 There is no further information"
public Majid Assadi
The Persian Gulf 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 Persian Gulf 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) Age ≥18 years Patients with confirmed HER2-positive breast cancer using 68Ga-Trastuzumab PET/CT Eastern Cooperative Oncology Group Performance Status (ECOG) ≤ 2 Having hematologic parameters as: (i) Absolute neutrophil count ≥ 1000 cells/mm3; (ii) Platelet count ≥ 100,000/mm3; (iii) Hemoglobin ≥ 9 g/dL Signed informed consent form 18 years no limit Female Pregnant woman Inability to provide written informed consent. Patients with known sensitivity or contraindication to Herceptin. The patient had an active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy. Patients have psychiatric illness/social situations that would interfere with compliance with study requirements C50 Malignant neoplasm of breast Treatment - Drugs Intervention group: In this study, the 177Lu-Trastuzumab PET/CT radiopharmaceutical is injected intravenously into 15 patients with breast cancers according to the 68Ga-Trastuzumab PET/CT. Then whole-body scan is performed at 24 hours, and 48 hours after injection to assess radiotracer distribution. Six to eight weeks after the 177Lu-Trastuzumab PET/CT therapy, the patients will be visited by oncologists and nuclear medicine physicians and if there was not any toxicity, the next treatment session will be performed. Numbe of treated breast cancer patients. Timepoint: 4-6 weeks after last treatment session. Method of measurement: Image-based response using 68Ga-Trastuzumab PET/CT. Boushehr University of Medical Sciences Approved 2021-06-27 Research Ethics Committees of Bushehr province university of medical sciences Bushehr University of Medical Science, Moallem Street, Bushehr, Iran Bushehr Boushehr Iran (Islamic Republic of)