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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT01403324
First received: July 26, 2011
Last updated: March 15, 2012
Last verified: July 2011
  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

Resource links provided by NLM:


Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01403324

Contacts
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

Locations
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         
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Investigators
Principal Investigator: Sophie LEBOULLEUX, MD Gustave Roussy, Cancer Campus, Grand Paris
  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 Gustave Roussy, Cancer Campus, Grand Paris:
metastatic or locally advanced differentiated thyroid cancer
planned for a therapeutic activity of 131I after thyroid hormone withdrawal

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 30, 2014