Overview

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

Status:
Terminated

Trial end date:
2016-06-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Gustave Roussy, Cancer Campus, Grand Paris

Treatments:

Hormones

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