Status:
TERMINATED
Comparison of Dosimetry After rhTSH or Withdrawal of Thyroid Hormone in Metastatic or Locally Advanced Thyroid Cancer
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Conditions:
Thyroid Cancer
Metastases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Metastases of thyroid cancer with iodine uptake are treated with repeated activity of I-131 administered after thyroid hormone withdrawal. The goal of thyroid hormone withdrawal is to treat patients w...
Detailed Description
Patients will undergo a rhTSH stimulation, staying on thyroid hormone treatment. Following 2 administration of rhTSH an injection of I-124 will be performed. Positron emission tomography with computed...
Eligibility Criteria
Inclusion
- Patients with thyroid cancer and known measurable (\>1cm) distant metastases demonstrating radioiodine uptake on a previous whole body scan
- Patients planned for a therapeutic activity of 131I after thyroid hormone withdrawal
- Age \>18 years
- Previous treatment with radioiodine more than 6 months before inclusion.
- Serum TSH level \<0.5 mU/L
- Normal renal function with a creatinine clearance estimation using the Cockcroft-Gault formula \> 60 ml/ml
- Effective means of contraception for female patient, at risk of pregnancy
- Written informed consent
Exclusion
- Patients whose majority of tumoral lesions disclose FDG uptake without radioactive iodine uptake
- Iodine excess (\< 50 μg/dl)
- Large or diffuse bone or brain metastases
- Patients with multiple small tumor foci less than 1 cm in diameter, such as miliary spread to the lungs
- Patients already included in a therapeutic trial with an experimental medicine
- Pregnancy and breast feeding patients
- Subject with any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
- Treatment with antivitamin k
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01403324
Start Date
September 1 2011
End Date
June 1 2016
Last Update
July 13 2016
Active Locations (1)
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1
Institut Gustave Roussy
Villejuif, France, 94805