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The Dose of Radioactive Iodine Needed to Ablate the Thyroid Remnant Left Behind After Thyroidectomy
This study is ongoing, but not recruiting participants.
Sponsor:
Helsinki University
Collaborator:
Helsinki University Central Hospital
Information provided by (Responsible Party):
Hanna Mäenpää, Helsinki University
ClinicalTrials.gov Identifier:
NCT00115895
First received: June 26, 2005
Last updated: March 18, 2016
Last verified: March 2016
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Thyroid Neoplasms | Drug: Radioactive iodine | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effect of the Radioiodine Dose in Thyroid Ablation- A Randomized Comparison of 1110 MBq to 3700 MBq |
Resource links provided by NLM:
Further study details as provided by Hanna Mäenpää, Helsinki University:
Primary Outcome Measures:
- Cumulative number of radioactive iodine administrations [ Time Frame: 15 yrs ]
Secondary Outcome Measures:
- Adverse events [ Time Frame: 15 yrs ]
- Absorbed radiation dose [ Time Frame: 15 yrs ]
- Cancer recurrence [ Time Frame: 15 yrs ]
| Enrollment: | 160 |
| Study Start Date: | January 2000 |
| Estimated Study Completion Date: | September 2020 |
| Primary Completion Date: | October 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Radioactive iodine 1,1 GBq
Low activity of radioiodine, 1,1 GBq
|
Drug: Radioactive iodine
Radioiodine is radionuclear treatment given in oral capsules in two activies 1,1 and 3,7 GBq
Other Name: radioiodine
|
|
Radioactive iodine 3,7 GBq
Routine activity of radioiodine, 3,7 GBq
|
Drug: Radioactive iodine
Radioiodine is radionuclear treatment given in oral capsules in two activies 1,1 and 3,7 GBq
Other Name: radioiodine
|
Detailed Description:
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:
- To find out weather the risk for second radioiodine treatment differs with two dose levels of radioiodine: 1110 MBq or 3700 MBq.
- To study possible differences in the adverse effects in the treatment groups. Also days at hospital are counted.
- To analyse the effect of absorbed radiation dose to the treatment results
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Total or near total thyroidectomy performed for papillary or follicular thyroid cancer
- R0-1 resection, no macroscopic cancer left behind at surgery
- Physically and emotionally able to undergo radioiodine treatment
- A written informed consent
Exclusion criteria:
- Pregnancy
- Physical or psychiatric illness that may deteriorate during the isolation period required by radioiodine therapy
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00115895
Please refer to this study by its ClinicalTrials.gov identifier: NCT00115895
Locations
| Finland | |
| Helsinki University Central Hospital, Department of Oncology | |
| Helsinki, Finland, FIN-00029HUS | |
Sponsors and Collaborators
Helsinki University
Helsinki University Central Hospital
Investigators
| Principal Investigator: | Hanna O Mäenpää, M.D. Ph.D. | Deputy Chief Physician |
More Information
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Hanna Mäenpää, Chief of Department, Helsinki University |
| ClinicalTrials.gov Identifier: | NCT00115895 History of Changes |
| Other Study ID Numbers: |
SYTJ001T/2000 |
| Study First Received: | June 26, 2005 |
| Last Updated: | March 18, 2016 |
Keywords provided by Hanna Mäenpää, Helsinki University:
|
radioiodine serum thyroglobulin whole body radioiodine scanning |
Additional relevant MeSH terms:
|
Thyroid Diseases Thyroid Neoplasms Endocrine System Diseases Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms Iodine |
Cadexomer iodine Anti-Infective Agents, Local Anti-Infective Agents Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 22, 2017