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The study aims at clarifying (in a randomized, double-blinded design):
The two studies will be carried out successively on the same patient population. The 131I uptake will be carried out first followed by the I therapy itself. The patients are compared with a placebo-treated control group going through the same course of treatment, but the 131I dosis will be 100 Gy (standard treatment). After the 131I therapy, all patients are followed during one year with a regular ultrasound scan of the thyroid gland and control of the metabolic status. The patient satisfaction is monitored by the use of a visual-analogue-scale.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rhTSH | Active Comparator | proceeded by 0.1 mg rhTSH |
|
| Placebo | Placebo Comparator | 1 ml isotonic saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant human thyrotropin (Thyrogen) | Drug | 0.1 mg rhTSH administered intramuscularly |
| |
| Measure | Description | Time Frame |
|---|---|---|
| An intra-individual comparison of the thyroid 131I-uptake before and after stimulation with rhTSH /placebo | 24 and 96 hours after tracer administration | |
| An inter-individual comparison of the thyroid 131I uptake between those who receive placebo and those who receive rhTSH | 24 and 96 hours after tracer administration | |
| An estimation of which time-interval, injecting rhTSH, that is more favourable before 131I therapy (24 hours, 48 hours or 72 hours) | 24 and 96 hours after tracer administration | |
| A comparison of the degree of goiter reduction when patients are prestimulated with rhTSH and receive a thyroid 131I dose of 50 Gy or when receiving conventional 131I, receiving a thyroid dose of 100 Gy | 3, 6, 9 and 12 months after 131I therapy |
| Measure | Description | Time Frame |
|---|---|---|
| A registration of adverse effects following rhTSH/placebo | All adverse effects occuring within one year follow-up | |
| Patient satisfaction (Visual Analogue Scale) before, 3 months post 131I therapy, and at the end of follow-up (1 year). | baseline, 3 and 12 months after 131I therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steen J. Bonnema, MD | Odense University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense University Hospital | Odense | 5000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34961921 | Derived | Huo Y, Xie J, Chen S, Wang H, Ma C. Recombinant human thyrotropin (rhTSH)-aided radioiodine treatment for non-toxic multinodular goitre. Cochrane Database Syst Rev. 2021 Dec 28;12(12):CD010622. doi: 10.1002/14651858.CD010622.pub2. | |
| 20519346 | Derived | Fast S, Hegedus L, Grupe P, Nielsen VE, Bluhme C, Bastholt L, Bonnema SJ. Recombinant human thyrotropin-stimulated radioiodine therapy of nodular goiter allows major reduction of the radiation burden with retained efficacy. J Clin Endocrinol Metab. 2010 Aug;95(8):3719-25. doi: 10.1210/jc.2010-0634. Epub 2010 Jun 2. |
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| recombinant human TSH |
| Drug |
0.1 mg rhTSH administered intramuscularly |
|
| isotonic saline = placebo | Other | 0.1 mg isotonic saline injected intramuscularly |
|
| Development of TPOab or TSHRab | At 12 months follow-up |
| Thyroid function | At 12 months follow up. |
| ID | Term |
|---|---|
| D006044 | Goiter, Nodular |
| ID | Term |
|---|---|
| D006042 | Goiter |
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D057073 | Thyrotropin Alfa |
| ID | Term |
|---|---|
| D013972 | Thyrotropin |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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