]>
IRCT20211206053304N1 IRCT 2022-08-22 Iran University of Medical Sciences 177Lu-FAPI in cancer therapy Initial evaluation of the therapeutic efficacy of 177Lu-FAPI in patients with various end-stage metastatic cancers resistant to standard therapies 2022-09-23 anticipated 10 Complete https://irct.ir/trial/65268 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 1 end-stage metastatic gastrointestinal or breast cancer. Intervention group: the selected patients go through PET/CT (68Ga-FAPI radiopharmaceutical about 6 mCi dose) or SPECT/CT (99mTc-FAPI radiopharmaceutical about 20 mCi dose) scan at first. The therapeutical 177Lu-FAPI radiopharmaceutical ( about 86 mCi) will be injected. the manufacturare of the radiopharmaceuticals is Pars Isotope company. Then the scintigraphy will be done to show the radiopharmaceutical accumulation sits. based on the results of the study additional treatment will be evaluated and determined.. 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 more information.
public Leila Hassanzadeh
No. 3, Homa Alley, Hafezi Ave., Farahzadi Blvd., Qods Town
Tehran Iran (Islamic Republic of) 1468793336 +98 21 2235 5715 Hassanzadeh.l@iums.ac.ir Iran University of Medical Sciences scientific Leila Hassanzadeh
No. 3, Homa Alley, Hafezi Ave., Farahzadi Blvd.,
Tehran Iran (Islamic Republic of) 1468793336 +98 21 8670 5503 hassanzadeh.l@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) the patient should be able to understand and sign off the informed consent. The patient should be able to understand and follow the treatment protocol. Patients should be older than 18. The patients life expectancy should be over 6 months. patients should show no response to the standard treatment. The 68Ga-FAPI PET scan or 99mTc-FAPI SPECT scan should show 3 times more uptake of radiopharmaceutical in tumor to liver of the patients. the patient with progressive disease should be included. 18 years no limit Both The patients who have received therapeutic radiopharmaceuticals like, 223Ra, 188Re, 186Re, 153Sm during last 6 months. The patients are under systemic therapies like chemotherapy, immunotherapy, or biological treatment for cancer. The patients who have been under any research treatment during 28 days before entrance in this study. The patients who have shown any known allergy to the therapeutic radiopharmaceuticals. The patients who have congestive heart failure. Treatment - Drugs Intervention group: the selected patients go through PET/CT (68Ga-FAPI radiopharmaceutical about 6 mCi dose) or SPECT/CT (99mTc-FAPI radiopharmaceutical about 20 mCi dose) scan at first. The therapeutical 177Lu-FAPI radiopharmaceutical ( about 86 mCi) will be injected. the manufacturare of the radiopharmaceuticals is Pars Isotope company. Then the scintigraphy will be done to show the radiopharmaceutical accumulation sits. based on the results of the study additional treatment will be evaluated and determined. Amount of pain feeling on the bone. Timepoint: Just before treatment and every 4 weeks after treatment. Method of measurement: Using Visual Analogue Scale questionnaire. Performance Status (quality of life). Timepoint: Before treatment and every 4 weeks after treatment. Method of measurement: Eastern Cooperative Oncology Group (ECOG) Performance Status. Iran University of Medical Sciences Approved 2022-08-02 Ethics committee of Iran University of Medical Sciences No. 3, Homa Alley, Hafezi Ave., Farahzadi Blvd., Qods Town. Tehran Tehran Iran (Islamic Republic of)