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The Dose of Radioactive Iodine Needed to Ablate the Thyroid Remnant Left Behind After Thyroidectomy

Effect of the Radioiodine Dose in Thyroid Ablation- A Randomized Comparison of 1110 MBq to 3700 MBq

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00115895
Enrollment
160
Registered
2005-06-27
Start date
2000-01-31
Completion date
2020-09-30
Last updated
2018-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Neoplasms

Keywords

radioiodine, serum thyroglobulin, whole body radioiodine scanning

Brief summary

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.

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

Interventions

Radioiodine is radionuclear treatment given in oral capsules in two activies 1,1 and 3,7 GBq

Sponsors

Helsinki University Central Hospital
CollaboratorOTHER
University of Helsinki
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Cumulative number of radioactive iodine administrations15 yrs

Secondary

MeasureTime frame
Adverse events15 yrs
Absorbed radiation dose15 yrs
Cancer recurrence15 yrs

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 5, 2026