Comparison of Dosimetry After rhTSH or Withdrawal of Thyroid Hormone in Metastatic or Locally Advanced Thyroid Cancer
Information source: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Thyroid Cancer; Metastases
Intervention: TSH stimulation (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Gustave Roussy, Cancer Campus, Grand Paris Official(s) and/or principal investigator(s): Sophie LEBOULLEUX, MD, Principal Investigator, Affiliation: Gustave Roussy, Cancer Campus, Grand Paris
Overall contact: Sophie LEBOULLEUX, MD, Phone: 33 1 42 11 42 57, Email: leboulleux@igr.fr
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 with elevated thyrotropin stimulated hormone (TSH), a hormone secreted by the
pituitary, a gland just located under the brain. Another way to obtain elevated TSH levels
is to perform intramuscular injection of recombinant human TSH, a hormone produced
pharmaceutically. The goal of this study is to know whether the radioiodine uptake by the
metastases is similar after rhTSH administration or after thyroid hormone withdrawal.
Clinical Details
Official title: 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
Study design: Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: the 124 I uptake after TSH stimulation
Secondary outcome: The activity of 131I that should be administered according to each TSH stimulation methodRadiation exposure of the blood
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 tomography scans (PET/CT), blood tests, and measurements of whole
body radioactivity will occurred during the 4 to 96 hours following I-124 administration in
order to perform dosimetry (i. e.) to estimate the radiation dose delivered to the
metastases. After 4 weeks under thyroid hormones patients will undergo thyroid hormone
withdrawal and a new administration of I-124 will be performed. The same dosimetry study
will be realized with PET/CT, blood tests, and measurements of whole body radioactivity. A
therapeutic activity of I-131will then be administered followed by whole body scan realized
24 to 72 hours after the administration of I-131. Dosimetry studies will be compared in
order to determine whether rhTSH stimulation can replace thyroid hormone withdrawal for the
treatment of distant metastases.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Sophie LEBOULLEUX, MD, Phone: 33 1 42 11 42 57, Email: leboulleux@igr.fr
Institut Gustave Roussy, Villejuif 94805, France; Recruiting Sophie LEBOULLEUX, MD, Phone: 33 1 42 11 42 57, Email: leboulleux@igr.fr Sophie LEBOULLEUX, MD, Principal Investigator
Additional Information
Starting date: September 2011
Last updated: March 15, 2012
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