Comparison of Dosimetry After rhTSH or Withdrawal of Thyroid Hormone in Metastatic or Locally Advanced Thyroid Cancer (DOSIMETA)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Thyroid Cancer Metastases |
Drug: TSH stimulation |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Crossover Assignment Masking: Open Label |
| 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 |
- the 124 I uptake after TSH stimulation [ Time Frame: 4 to 96 hours ] [ Designated as safety issue: No ]For each patient, the 124 I uptake after TSH stimulation (a marker of radiation absorbed dose) will be compared to the uptake after thyroid withdrawal in all lesions (up to 16 lesions per patient maximum). A decrease in the residence time of more than 2.5 fold in 25% or more of the lesions is considered unacceptable.
- The activity of 131I that should be administered according to each TSH stimulation method [ Time Frame: 96 hours ] [ Designated as safety issue: No ]To determine the activity of 131I that should be administered following rhTSH to deliver a radiation absorbed dose similar to that delivered under hypothyroid conditions. A calculated activity above 250mCi is considered unacceptable.
- Radiation exposure of the blood [ Time Frame: 4 to 96 hours ] [ Designated as safety issue: Yes ]The radiation exposure of the blood, calculated from blood samples and whole body radioactivity measurements
| Estimated Enrollment: | 35 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
TSH stimulation
rh TSH stimulation followed by thyroid hormon withdrawal
|
Drug: TSH stimulation
rh TSH stimulation followed by thyroid hormon withdrawal
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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
Contacts and Locations| Contact: Sophie LEBOULLEUX, MD | 33 1 42 11 42 57 | leboulleux@igr.fr |
| Contact: Desiree DEANDREIS, MD | 33 1 42 11 50 25 | Desiree.DEANDREIS@igr.fr |
| France | |
| Institut Gustave Roussy | Recruiting |
| Villejuif, France, 94805 | |
| Contact: Sophie LEBOULLEUX, MD 33 1 42 11 42 57 leboulleux@igr.fr | |
| Principal Investigator: Sophie LEBOULLEUX, MD | |
| Principal Investigator: | Sophie LEBOULLEUX, MD | Institut Gustave Roussy |
More Information
No publications provided
| Responsible Party: | Gilles VASSAL, Institut Gustave Roussy, 94805 Villejuif, France |
| ClinicalTrials.gov Identifier: | NCT01403324 History of Changes |
| Other Study ID Numbers: | DOSIMETA IGR2010/1645 |
| Study First Received: | July 26, 2011 |
| Last Updated: | March 15, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: ASN - Nuclear Security Authority |
Keywords provided by Institut Gustave Roussy:
|
metastatic or locally advanced differentiated thyroid cancer planned for a therapeutic activity of 131I after thyroid hormone withdrawal |
Additional relevant MeSH terms:
|
Thyroid Neoplasms Thyroid Diseases Neoplasm Metastasis Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms |
Endocrine System Diseases Neoplastic Processes Pathologic Processes Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013