Clinical trial · Interventional
Comparison of Dosimetry After rhTSH or Withdrawal of Thyroid Hormone in Metastatic or Locally Advanced Thyroid Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Recruitment difficulties
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastases | Thyroid Gland Neoplasm | PROBABILISTIC | 0.70 |
| Thyroid Cancer | Malignant Thyroid Gland Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TSH stimulation | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- TSH stimulation
- description
- rh TSH stimulation followed by thyroid hormon withdrawal
- interventionNames
- Drug: TSH stimulation
Primary outcomes (1)
- measure
- the 124 I uptake after TSH stimulation
- timeFrame
- 4 to 96 hours
- 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.
Secondary outcomes (2)
- measure
- The activity of 131I that should be administered according to each TSH stimulation method
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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