Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-25 @ 2:23 AM
NCT ID:
NCT02390934
Eligibility Criteria:
Inclusion Criteria:
1. Affiliated to a social security regimen ;
2. Patients with histologically confirmed differentiated thyroid cancer (papillary, follicular including Hurthle cell or poorly differentiated) ;
3. Iodine refractory disease defined by the absence of radioiodine uptake in at least one lesion or progression of the disease within 14 months after a radioactive iodine (RAI) treatment or persistent disease after the administration of a cumulative activity of 22GBq I 131 ;
4. Age ≥18 years ;
5. Eastern Cooperative Oncology Group performance status 0-2 ;
6. Life expectancy longer than 3 months ;
7. Presence of at least one bone metastasis visible on CT scan or axial skeleton (AS) MRI and not requiring urgent locoregional treatment ;
8. Presence of at least one bone metastasis with uptake on FDG PET/CT ;
9. Presence of at least one bone metastasis with increased uptake on 99mTc HMDP bone scintigraphy or FNa PET/CT
10. Low likelihood of an indication for systemic treatment within the next 6 months, as defined by the absence of soft tissue distant metastases or by the presence of only small (\<1cm) soft-tissue metastases, or larger (\>1 cm) but stable soft tissue metastases within 6 months prior to inclusion in the present protocol ;
11. Adequate haematological (neutrophils ≥1,5×109/L; platelets ≥100×109/ L; haemoglobin \> 9g/dL), renal (creatinine \<1,5×upper limit of normal range), and hepatic (total bilirubin \< 1.5 institutional upper limit of normal), aspartate aminotransferase and alanine aminotransferase \<2,5×upper limit of normal range in the absence of liver metastases or \<5×upper limit of normal range in case of liver metastases) functions ;
12. Patients receiving bisphosphonates or anti-RANK ligand (Denosumab) are allowed but patients should have received at least 2 administrations prior to Radium-223 administration and these treatments will be continued during Radium-223 treatment ;
13. Blood negative pregnancy test in women of childbearing potential within 30 days prior to treatment initiation. Both men and women (of childbearing potential) who are sexually active must use adequate contraception during and for at least 6 months post-treatment ;
14. Patient who is fully informed, able to comply with the protocol and who signed the informed consent.
Exclusion Criteria:
1. Patients with another malignancy that is not in remission for at least 2 years (except for in situ cervix uterine cancer, basocellular skin cancer) ;
2. Treatment with any investigational drug or with a TKI within the previous 4 weeks, or planned during the treatment period ;
3. Treatment with cytotoxic chemotherapy within the previous 4 weeks, or planned during the treatment period, or failure to recover from adverse events due to cytotoxic chemotherapy administered more than 4 weeks before the study initiation ;
4. Previous systemic therapy with radionuclides, including strontium-89, samarium-153, rhenium-186, rhenium-188 or radium-223 ;
5. Patients with imminent or established spinal cord compression based on clinical findings and/or MRI and/or immediate need for local radiotherapy ;
6. Patients with progressive visceral metastases according to RECIST 1.1 criteria assessed by CT scan and/or symptomatic brain metastases within 6 months prior to study initiation ;
7. Patient already included in other clinical trial ;
8. Pregnant or breast feeding women ;
9. Fecal or urinary unmanageable incontinence ;
10. Bone marrow dysplasia, uncontrolled diabetes or infection, NYHA Class III or IV cardiac disorders, fecal incontinence and symptomatic intestinal disease (such as Crohn disease or ulcerative colitis).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02390934
Study Brief:
Protocol Section:
NCT02390934