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IRCT20230803059015N1 IRCT 2023-08-14 Shiraz University of Medical Sciences Effectiveness of Lu177-PSMA in treatment of refractory thyroid papillary cancer. Evaluating the theranostic application of Lu177-PSMA in management of refractory thyroid papillary cancer. 2023-08-23 anticipated 10 Complete https://irct.ir/trial/71836 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: The multidisciplinary tumor board, consisting of a surgeon, an endocrinologist, a radio-oncologist, and a nuclear medicine specialist, will review the data of metastatic radioiodine refractory papillary thyroid cancer (RR-PTC) patients and evaluate their eligibility for participating in the study. 2 radio-iodine refractory papillary thyroid cancer. Intervention 1: Intervention group: The multidisciplinary tumor board will decide whether patients were eligible for the treatment with 177Lu-PSMA-617. Patients will be considered eligible if one or more metastases were predominantly PSMA positive on 58Ga-PSMA PET/CT or Tc99m-PSMA SPECT/CT with no evidence of any non-PSMA/ non-iodine avid lesions. 10 Patients that have the criteria for the therapy, will be planned for two to four cycles of 177Lu-PSMA therapy according to rhe level of response and the occurrence of the side effects after the first two cycles. The administered activity will be between 150-200 GBq per cycle proportional to the number and avidity of PSMA-avid lesions. After the administration of ondansetron (8mg IV) and the application of icepack on salivary glands for 30 minutes, the therapeutic radiotracer will be administered by slow intravenous infusion in the inpatients setting with concomitant IV hydration with 1-2 L normal saline during 1-2 hours. In cases with cerebral or spinal metastasis and those with high metastatic volume, dexamethasone ۸mg will be administered daily from one day before the therapy to two days. The interval between each treatment cycle is 6 to 8 weeks based on the related guideline for use of Lu177-PSMA in the other metastatic cancers. During this period, CBc and renal function test will be evaluated every two weeks and will be recorded for the evaluation of any possible toxicity. The patients will be studied for at least 8 months after the therapy for the evaluation of their response to the therapy. Intervention 2: 10 patients with radio-iodine refractory papillary thyroid cancer with other options of treatment like tyrosine kinase inhibitors and variables will compare in two groups. Yes - There is a plan to make this available What will be shared: The results and the data related to the treatment method and how to perform the treatment will be provided to interested people. When: Access starts 6 months after publication of results To whom: All people interested in the subject of study Conditions: It is accessible by maintaining the confidentiality of the data. Where to obtain: Dr. Zainab Amirkhani, email znbamirkhaninew@gmail.Com How to obtain: The applicants should explain the reason for the request and the method of trust through email, and if the project managers agree, the results will be provided for them. Comments:
public Zeinab amirkhani
Seyyed al-Shohada Hospital (AS), Nehar Farshadi Street, Khayam Street
Isfahan Iran (Islamic Republic of) 8184917354 +98 31 3236 6015 Znbamirkhaninew@gmail.com Esfahan University of Medical Sciences scientific Tahere Qaediyan
Zand Street, Namazi Square, Namazi Hospital, Nuclear Medicine Department
Shiraz Iran (Islamic Republic of) 1331171936 +98 917 307 7729 tghaedian@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients with metastatic radio-iodine refractory papillary thyroid cancer Patients with baseline, WBC>3000, Hb>9, platelete .cont>70000, AST and ALT<5*nl limit and Cr<2*nl limit 18 years no limit Both Patients who refused to participate in the study Life-expectancy of <1 month History of other concomittant cancer or other end-stage organ disease Patients with baseline, WBC<3000, Hb<9, platelete .cont<70000, AST and ALT>5*nl limit and Cr>2*nl limit Treatment - Drugs Treatment - Other Intervention group: The multidisciplinary tumor board will decide whether patients were eligible for the treatment with 177Lu-PSMA-617. Patients will be considered eligible if one or more metastases were predominantly PSMA positive on 58Ga-PSMA PET/CT or Tc99m-PSMA SPECT/CT with no evidence of any non-PSMA/ non-iodine avid lesions. 10 Patients that have the criteria for the therapy, will be planned for two to four cycles of 177Lu-PSMA therapy according to rhe level of response and the occurrence of the side effects after the first two cycles. The administered activity will be between 150-200 GBq per cycle proportional to the number and avidity of PSMA-avid lesions. After the administration of ondansetron (8mg IV) and the application of icepack on salivary glands for 30 minutes, the therapeutic radiotracer will be administered by slow intravenous infusion in the inpatients setting with concomitant IV hydration with 1-2 L normal saline during 1-2 hours. In cases with cerebral or spinal metastasis and those with high metastatic volume, dexamethasone ۸mg will be administered daily from one day before the therapy to two days. The interval between each treatment cycle is 6 to 8 weeks based on the related guideline for use of Lu177-PSMA in the other metastatic cancers. During this period, CBc and renal function test will be evaluated every two weeks and will be recorded for the evaluation of any possible toxicity. The patients will be studied for at least 8 months after the therapy for the evaluation of their response to the therapy. 10 patients with radio-iodine refractory papillary thyroid cancer with other options of treatment like tyrosine kinase inhibitors and variables will compare in two groups Serum thyroglobulin level. Timepoint: Monthly. Method of measurement: Blood sampling. PSMA avid lesions. Timepoint: Before and after completing the treatment. Method of measurement: Diagnostic method with ۶۸Ga-PSMA PET/CT or alternative imaging (Tc۹۹m-PSMA). Shiraz University of Medical Sciences Approved 2023-02-28 Ethics committee of Shiraz University of Medical Sciences 5th floor, Shiraz University Central Building, Islamic Republic Boulevard Shiraz Fars Iran (Islamic Republic of)