Study of Metformin activity in patients with differentiated thyroid cancer metastasis with minimally progressive development - Metformin in patients with DTC

ENTE OSPEDALIERO OSPEDALI GALLIERA0 个研究点目标入组 20 人开始时间: 2021年6月8日最近更新: 2021年8月24日

适应症

试验速览

暂无简介。

•1) Age> 18 years.
•2) high-risk DTC (according to ATA 2015 classification) histologically proven;
•3) total thyroidectomy and previous radiometabolic therapy with 131I (administered activity between 2.96 GBq and 3.7 GBq);
•4) no evidence of distant metastases at disease onset;
•5) evidence of structural relapse over time treated with a second administration of RAI (activity from 5.5 GBq to 7.4 GBq).
•6) absence of cancer-specific metastatic symptoms and absence of impending cancer-specific symptoms;
•7) no iodine-greedy metastases after the second RAI;
•8) Patients with evidence of slow disease progression (e.g. time to doubling of lung metastasis volume> 1 year) not susceptible to further surgery and candidates for active surveillance;
•9) biochemical progression (i.e. increase in Tg levels in the last year).
•10) preserved renal function (creatinine clearance estimated by Cockcroft-Gault formula = 60 mL / min;)
•11) normal liver function (values of AST, ALT, Total Bilirubin, gammaGT and alkaline phosphatase> 1.5 times the upper limit of the normal range)
•12) Signature of informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 10
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

发起方