The Dose of Radioactive Iodine Needed to Ablate the Thyroid Remnant Left Behind After Thyroidectomy
NCT ID: NCT00115895
Last Updated: 2018-03-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
160 participants
INTERVENTIONAL
2000-01-31
2020-09-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Radioactive iodine 1,1 GBq
Low activity of radioiodine, 1,1 GBq
Radioactive iodine
Radioiodine is radionuclear treatment given in oral capsules in two activies 1,1 and 3,7 GBq
Radioactive iodine 3,7 GBq
Routine activity of radioiodine, 3,7 GBq
Radioactive iodine
Radioiodine is radionuclear treatment given in oral capsules in two activies 1,1 and 3,7 GBq
Interventions
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Radioactive iodine
Radioiodine is radionuclear treatment given in oral capsules in two activies 1,1 and 3,7 GBq
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* R0-1 resection, no macroscopic cancer left behind at surgery
* Physically and emotionally able to undergo radioiodine treatment
* A written informed consent
Exclusion Criteria
* Physical or psychiatric illness that may deteriorate during the isolation period required by radioiodine therapy
18 Years
ALL
No
Sponsors
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Helsinki University Central Hospital
OTHER
University of Helsinki
OTHER
Responsible Party
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Hanna Mäenpää
Chief of Department
Principal Investigators
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Hanna O Mäenpää, M.D. Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Deputy Chief Physician
Locations
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Helsinki University Central Hospital, Department of Oncology
Helsinki, , Finland
Countries
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References
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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.
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.
Related Links
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Helsinki University Central Hospital
Other Identifiers
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SYTJ001T/2000
Identifier Type: -
Identifier Source: org_study_id
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