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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01403324 |
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Date of registration:
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26/07/2011 |
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Primary sponsor: |
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Public title:
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Comparison of Dosimetry After rhTSH or Withdrawal of Thyroid Hormone in Metastatic or Locally Advanced Thyroid Cancer
DOSIMETA |
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Scientific title:
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Comparison of Dosimetry Following Preparation With Either rhTSH or After Withdrawal of Thyroid Hormone Suppression Therapy in Patients With Metastatic or Locally Advanced Differentiated Thyroid Cancer |
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Date of first enrolment:
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September 2011 |
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Target sample size:
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35 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01403324 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label
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Countries of recruitment
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France
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Contacts
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Name:
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Sophie LEBOULLEUX, MD |
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Address:
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Telephone:
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33 1 42 11 42 57 |
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Email:
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leboulleux@igr.fr |
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Affiliation:
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Name:
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Sophie LEBOULLEUX, MD |
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Address:
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Telephone:
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33 1 42 11 42 57 |
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Email:
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leboulleux@igr.fr |
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Affiliation:
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Name:
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Sophie LEBOULLEUX, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institut Gustave Roussy |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Patients with thyroid cancer and known measurable (>1cm) distant metastases
demonstrating radioiodine uptake on a previous whole body scan
2. Patients planned for a therapeutic activity of 131I after thyroid hormone withdrawal
3. Age >18 years
4. Previous treatment with radioiodine more than 6 months before inclusion.
5. Serum TSH level <0.5 mU/L
6. Normal renal function with a creatinine clearance estimation using the
Cockcroft-Gault formula > 60 ml/ml
7. Effective means of contraception for female patient, at risk of pregnancy
8. Written informed consent
Exclusion Criteria:
1. Patients whose majority of tumoral lesions disclose FDG uptake without radioactive
iodine uptake
2. Iodine excess (< 50 µg/dl)
3. Large or diffuse bone or brain metastases
4. Patients with multiple small tumor foci less than 1 cm in diameter, such as miliary
spread to the lungs
5. Patients already included in a therapeutic trial with an experimental medicine
6. Pregnancy and breast feeding patients
7. 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
8. Treatment with antivitamin k
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Metastases
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Thyroid Cancer
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Intervention(s)
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Drug: TSH stimulation
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Primary Outcome(s)
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the 124 I uptake after TSH stimulation
[Time Frame: 4 to 96 hours]
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Secondary Outcome(s)
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Radiation exposure of the blood
[Time Frame: 4 to 96 hours]
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The activity of 131I that should be administered according to each TSH stimulation method
[Time Frame: 96 hours]
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Secondary ID(s)
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DOSIMETA IGR2010/1645
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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