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IRCT20210612051548N2 IRCT 2021-09-28 Boushehr University of Medical Sciences 177Lu-DOTA-FAPI Therapy Efficiency of 177Lu-DOTA-FAPI Therapy in Treatment of Patients With Various Types of Cancer (Primary Locally Advanced or Metastatic Cancers) 2021-09-23 anticipated 30 Complete https://irct.ir/trial/56860 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 Condition 1: Brain tumors. Condition 2: Thyroid cancer resistant to radioactive iodine therapy. Condition 3: Gastrointestinal tumor. Condition 4: Lung cancer. Condition 5: Prostate cancer. Condition 6: Malignant female genital organs. Condition 7: Urinary tract cancer. Condition 8: Breast cancer. Condition 9: Malignant neoplasm of head, face and neck. Intervention group: In this study, 7.4 GBq (200 mCi) of 177Lu-DOTA-FAPI is injected intravenously into 30 patients with various types of cancers that demonstrated high FAP expression according to the 68Ga-DOTA-FAPI PET/CT or 99mTc-DOTA-FAPI SPECT. 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-DOTA-FAPI 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 No Additional 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) The presence of at least one tumoral lesion detected by 68Ga-DOTA-FAPI PET/CT or 99mTc-DOTA-FAPI SPECT Having hematologic parameters as: (i) Absolute neutrophil count ≥ 1000 cells/mm3; (ii) Platelet count ≥ 100,000/mm3; (iii) Hemoglobin ≥ 8 g/dL Participants who sign the informed consent form which was assented according to the guidelines of the Clinical Research Ethics Committee (signed by participant, parent, or legal representative). Eastern Cooperative Oncology Group Performance Status (ECOG) ≤ 2 18 years 90 years Both Patient had history of class 3 or 4 congestive heart failure (CHF) Patient had clinically significant bleeding within two weeks prior to trial entry (e.g. gastrointestinal bleeding, intracranial bleeding) Pregnant or lactating women Patient have psychiatric illness/social situations that would interfere with compliance with study requirements Patient cannot undergo PET/CT or SPECT scanning because of weight limits Patient had an active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy. C71 C73 C15-C26 C34 C61 C57.8 C68.9 C50 C49.0 Malignant neoplasm of brain Malignant neoplasm of thyroid gland Malignant neoplasms of digestive organs Malignant neoplasm of bronchus and lung Malignant neoplasm of prostate Malignant neoplasm of overlapping sites of female genital organs Malignant neoplasm of urinary organ, unspecified Malignant neoplasm of breast Malignant neoplasm of connective and soft tissue of head, face and neck Treatment - Drugs Intervention group: In this study, 7.4 GBq (200 mCi) of 177Lu-DOTA-FAPI is injected intravenously into 30 patients with various types of cancers that demonstrated high FAP expression according to the 68Ga-DOTA-FAPI PET/CT or 99mTc-DOTA-FAPI SPECT. 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-DOTA-FAPI 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. Objective Tumour Response Rate - defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) divided by the total number of participants. Timepoint: 6-8 week after last session of treatment. Method of measurement: Observation and semi-quantification analysis via PET/CT imaging. Progression free survival (PSF). Timepoint: Average 2 years. Method of measurement: Medical imaging. 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) 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) 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) 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) 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) 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) 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) 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)