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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Thyroid Cancer, Metastases

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Outcome Measure:

the 124 I uptake after TSH stimulation

Outcome Description:

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.

Outcome Time Frame:

4 to 96 hours

Safety Issue:

No

Principal Investigator

Sophie LEBOULLEUX, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

DOSIMETA IGR2010/1645

NCT ID:

NCT01403324

Start Date:

September 2011

Completion Date:

September 2014

Related Keywords:

  • Thyroid Cancer
  • Metastases
  • metastatic or locally advanced differentiated thyroid cancer
  • planned for a therapeutic activity of 131I after thyroid hormone withdrawal
  • Thyroid Neoplasms
  • Neoplasm Metastasis
  • Thyroid Diseases

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