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| Name | Class |
|---|---|
| Helsinki University Central Hospital | OTHER |
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The thyroid cells take up iodine, and radioactive iodine is commonly used to irradiate residual thyroid tissue and thyroid cancer following surgical removal of the thyroid gland (thyroidectomy). A whole body radioactive iodine scanning is usually carried out after thyroidectomy to assess the amount of thyroid tissue left behind at surgery (that might still contain cancer), and to evaluate the presence of iodine avid lesions elsewhere in the body (that might be cancer metastases). A large dose of radioactive iodine is often given, still the optimal iodine dose to ablate the thyroid remnant after surgery is not known. In this study, two radioactive iodine doses are compared in the ablation of the thyroid remnant, a smaller (1110 MBq) dose and a larger (3700 MBq) dose. The study participants are randomly allocated using a 1:1 ratio to receive either the smaller or the larger radioactive iodine dose. These treatments are compared for safety, adverse effects, and the need for subsequent repeat treatments. The individual absorbed radiation doses are measured. The study hypothesis is that fewer repeat radioiodine treatments might be needed after the larger dose, but the larger dose might be associated with a higher frequency of adverse events.
The study participants are randomly allocated to receive either a 1110 MBq or a 3700 MBq dose of radioiodine (131I) approximately 5 weeks after thyroidectomy. Thyroxin substitution is initiated only after administration of radioactive iodine. Treatment efficacy is monitored using serum thyroglobulin measurements and whole body radioiodine scanning. The absorbed radiation dose at the thyroid remnant and the biological half-life of radioactive iodine are measured with SPECT, 131I iodine detector and a Geiger counter.
Treatment related adverse events are collected using structured forms 4 to 5 days, 2 weeks and 3 months after administration of radioiodine. The need for a repeat treatment is assessed 4 to 6 months after the first administration of radioiodine. The criteria for a repeat radioiodine treatment are serum thyroglobulin > 1 ug/L and/or presence of abnormal radioiodine uptake in a whole body radioiodine scanning, which is carried out following a 4-week interruption of thyroxin supplementation or following administration of rhTSH.
Number of patients: 160
Aims of the study:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radioactive iodine 1,1 GBq | Experimental | Low activity of radioiodine, 1,1 GBq |
|
| Radioactive iodine 3,7 GBq | Other | Routine activity of radioiodine, 3,7 GBq |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radioactive iodine | Drug | Radioiodine is radionuclear treatment given in oral capsules in two activies 1,1 and 3,7 GBq |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative number of radioactive iodine administrations | 15 yrs |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | 15 yrs | |
| Absorbed radiation dose | 15 yrs | |
| Cancer recurrence |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hanna O Mäenpää, M.D. Ph.D. | Deputy Chief Physician | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Central Hospital, Department of Oncology | Helsinki | FIN-00029HUS | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10348276 | Background | Roos DE, Smith JG. Randomized trials on radioactive iodine ablation of thyroid remnants for thyroid carcinoma--a critique. Int J Radiat Oncol Biol Phys. 1999 Jun 1;44(3):493-5. | |
| 18382668 | Derived | Maenpaa HO, Heikkonen J, Vaalavirta L, Tenhunen M, Joensuu H. Low vs. high radioiodine activity to ablate the thyroid after thyroidectomy for cancer: a randomized study. PLoS One. 2008 Apr 2;3(4):e1885. doi: 10.1371/journal.pone.0001885. |
| Label | URL |
|---|---|
| Helsinki University Central Hospital | View source |
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| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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| ID | Term |
|---|---|
| C000614965 | Iodine-131 |
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|
| 15 yrs |
| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |