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

Thyroid Cancer Clinical Trial

— DOSIMETA  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01403324
• Other study ID #: DOSIMETA IGR2010/1645
• Status: Terminated
• Phase: N/A
• First received: July 26, 2011
• Last updated: July 12, 2016
• Start date: September 2011
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: ASN - Nuclear Security Authority
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Metastases
• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Drug:
• TSH stimulation
rh TSH stimulation followed by thyroid hormon withdrawal

Locations

Country	Name	City	State
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the 124 I uptake after TSH stimulation	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.	4 to 96 hours	No
Secondary	The activity of 131I that should be administered according to each TSH stimulation method	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.	96 hours	No
Secondary	Radiation exposure of the blood	The radiation exposure of the blood, calculated from blood samples and whole body radioactivity measurements	4 to 96 hours	Yes