We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Dosimetry After rhTSH or Withdrawal of Thyroid Hormone in Metastatic or Locally Advanced Thyroid Cancer (DOSIMETA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01403324
Recruitment Status : Terminated (Recruitment difficulties)
First Posted : July 27, 2011
Last Update Posted : July 13, 2016
Sponsor:
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

Tracking Information
First Submitted Date  ICMJE July 26, 2011
First Posted Date  ICMJE July 27, 2011
Last Update Posted Date July 13, 2016
Study Start Date  ICMJE September 2011
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2011)		 the 124 I uptake after TSH stimulation [ Time Frame: 4 to 96 hours ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2011)
  • The activity of 131I that should be administered according to each TSH stimulation method [ Time Frame: 96 hours ]
    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 ]
    The radiation exposure of the blood, calculated from blood samples and whole body radioactivity measurements
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Dosimetry After rhTSH or Withdrawal of Thyroid Hormone in Metastatic or Locally Advanced Thyroid Cancer
Official Title  ICMJE 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
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 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE
  • Thyroid Cancer
  • Metastases
Intervention  ICMJE Drug: TSH stimulation
rh TSH stimulation followed by thyroid hormon withdrawal
Study Arms  ICMJE TSH stimulation
rh TSH stimulation followed by thyroid hormon withdrawal
Intervention: Drug: TSH stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 12, 2016)		 4
Original Estimated Enrollment  ICMJE
 (submitted: July 26, 2011)		 35
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01403324
Other Study ID Numbers  ICMJE DOSIMETA IGR2010/1645
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Gustave Roussy, Cancer Campus, Grand Paris
Original Responsible Party Gilles VASSAL, Institut Gustave Roussy, 94805 Villejuif, France
Current Study Sponsor  ICMJE Gustave Roussy, Cancer Campus, Grand Paris
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sophie LEBOULLEUX, MD Gustave Roussy, Cancer Campus, Grand Paris
PRS Account Gustave Roussy, Cancer Campus, Grand Paris
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP