SODIUM IODIDE (131I) for Metastatic differentiated thyroid carcinoma

Inclusion criteria

• {"criterion_text":"- Histo-pathological diagnosis of DTC\n- At least one documented non surgically-curable soft-tissue metastasis previously untreated\n- ECOG performance status = 0 - 1\n- Age ≥ 18 years old\n- Life expectancy > 6 months\n- Females of childbearing age must have negative serum pregnancy test prior to registration and agree to use birth control throughout the study and for 6 months after completion of therapy\n- Preserved hematologic and renal function (hemoglobin > 10 g/dL; WBC > 3500/uL; neutrophilis > 50%; PLT > 100000/uL; albumin ≥ 2.5 g/dL; creatinine ≤ 2 mg/dL)\n- Signed informed consent"}

Exclusion criteria

• {"criterion_text":"- All lesions surgically resectable\n- Assumption of any myelotoxic drugs\n- Previous or concomitant assumption of Amiodarone\n- Any other oncologic disease that required systemic treatment in the last 5 years. Cases who received previous loco-regional therapy on non-target lesions can be included (for example radiotherapy or surgery)\n- Minimal lymph neck nodal disease (diameter < 1 cm, up to 2 nodes)\n- Patient with skeletal metastases only\n- Only lung uniformly diffuse miliary micro-metastases without other measurable nodules criteria\n- Ongoing pregnancy (enrollment could be considered after delivery)\n- Breast-feeding (enrollment could be considered after suspension)\n- Refusal of male and female patients to use an effective contraception method during the study and for 6 months after completion of protocol therapy\n- Impossibility to undergo follow-up procedures\n- Presence of medical, psychiatric or surgical condition, not adequately controlled by treatment, which would likely affect subjects’ ability to complete the protocol"}

Primary endpoints

• {"endpoint_text":"- Evaluation of complete response (CR) rate on soft tissue metastases after a maximum of two radioiodine administrations optimized with personalized pre-treatment dosimetry based on 124I-PET/CT. The response will be considered 6 months [1] after the last optimized administration, as a combination of evaluations (RECIST, 124I-PET/CT, 18F-FDG, and thyroglobulin).","definition_or_measurement_approach":"Response assessed 6 months after last optimized administration using a combination of evaluations: RECIST, 124I-PET/CT, 18F-FDG PET and thyroglobulin."}

Secondary endpoints

• {"endpoint_text":"- Assessment of acute toxicity rate and severity","definition_or_measurement_approach":"Evaluation of incidence and grade of acute toxicities (severity grading not further specified in the record)."}
• {"endpoint_text":"- Assessment of the association among pre-treatment glucose metabolism, 124I uptake and therapy response","definition_or_measurement_approach":"Correlation analyses between pre-treatment glucose metabolism (presumably via 18F-FDG), 124I uptake and therapeutic response (methods not further specified)."}
• {"endpoint_text":"- Assessment of the association among genetic mutations on cancer tissue, pre- and post-treatment miRNA expression, pre- and post-treatment glucose metabolism, iodine uptake, and 131I therapy response","definition_or_measurement_approach":"Exploratory association analyses between tissue genetic mutations, miRNA expression changes, glucose metabolism changes, iodine uptake and 131I therapy response (detailed methods not specified)."}

Italy

Earliest CTIS Part Ii Submission Date

08-07-2024

Latest Decision Or Authorization Date

16-10-2024

Processing Time Days

100

Number Of Sites

2

Number Of Participants

50

Primary sponsor

Full Name

Fondazione IRCCS Istituto Nazionale Dei Tumori

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy