Metastatic Thyroid Cancer Therapy Optimization With 124I PET Dosimetry (131THEROPT124)
Metastatic Differentiated Thyroid Cancer
About this trial
This is an interventional treatment trial for Metastatic Differentiated Thyroid Cancer focused on measuring Thyroid cancer, dosimetry, 124-I, therapy optimization
Eligibility Criteria
Inclusion Criteria:
- Histo-pathological diagnosis of DTC
- At least one documented non surgically-curable soft-tissue metastasis previously untreated
- ECOG performance status = 0 - 1
- Life expectancy > 6 months
- 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
- Preserved hematologic and renal function (hemoglobin > 10 g/dL; WBC > 3500/uL; neutrophils > 50%; PLT > 100000/uL; albumin ≥ 2.5 g/dL; creatinine ≤ 2 mg/dL)
- Signed informed consent
Exclusion Criteria:
- All lesions surgically resectable
- Minimal lymph nodal disease (diameter < 1 cm, up to 2 nodes)
- Patient with skeletal metastases only
- Lung diffuse miliary micro-metastases
- Ongoing pregnancy
- Breast-feeding (enrollment could be considered after suspension)
- Refusal of male and female patients to use an effective contraception method during the study and for 6 months after completion of protocol therapy
- Impossibility to undergo follow-up procedures
- Presence of medical, psychiatric or surgical condition, not adequately controlled by treatment, which would likely affect subjects' ability to complete the protocol
- Assumption of any anti-tumor therapy including chemotherapy, biological or investigational drug treatments
- Assumption of any myelotoxic drugs
- Previous or concomitant assumption of Amiodarone
- Any other oncologic disease that required treatment in the last 5 years.
- Participation in a clinical trial in which an investigational drug was administered within 30 days or 5 half-lives prior to the study drug.
Sites / Locations
- Nuclear Medicine, Ospedale Sacro Cuore - Don CalabriaRecruiting
- Nuclear Medicine, Fondazione IRCCS Istituto Nazionale TumoriRecruiting
Arms of the Study
Arm 1
Experimental
Optimized therapy
Patients with ascertained metastatic differentiated thyroid cancer will be studied with FDG PET, CT, and for genetic characterization. 100 MBq of 124-I are administered for blood and PET lesion dosimetry. According Jentzen et al, good efficacy (Tumour Control Probability > 80%) is obtained with absorbed dose higher than 80 Gy to soft tissue metastases, and > 650 Gy to bone metastases. These values ae pursued with the limit of 2 Gy to blood. Only soft tissue lesions will be considered as target for the calculation of the complete response rate. However, for ethical reasons, therapeutic activity will be chosen in order to be effective both on soft tissue and bone lesions. Patients with too low predicted lesion absorbed dose even administering the Maximum Tolerable Activity (2 Gy to blood) will exit the protocol to receive the standard of care.