IoN

• Research type

  Research Study

• Full title

  ION– Is ablative radiOiodine Necessary for low risk differentiated thyroid cancer patients

• IRAS ID

  72777

• Contact name

  Colin Lunt

• Sponsor organisation

  Joint UCL/UCLH/RFH Biomedical Research Unit (1st floor, Maple House)

• Eudract number

  2011-000144-21

• ISRCTN Number

  ISRCTN80416929

• Research summary

  Total thryroidectomy (surgery to remove the thyroid gland) followed by Radioactive Iodine Ablation is the standard treatment for patients presenting with intermediate or high risk well differentiated thyroid cancer. Radioiodine (RAI) is mainly used to eliminate any residual normal thyroid tissue. In a sub-group of patients characterised as having low risk of recurrence there is debate as to whether ablation represents over-treatment. RAI causes many side effects including increased risk of a second primary cancer.IoN will answer the question of whether RAI is necessary for low risk differentiated thyroid cancer patients who already have been offered the other two important modalities of treatment i.e. Total Thyroidectomy and optimal TSH (Thyroid Stimulating Hormone) suppression. Patients who have undergone a total thyroidectomy will be randomised (allocated randomly) into one of two groups by a computer program. One group will receive ablation at an activity of 1.1 GBq (Giga Becquerels), the other will not receive ablation. There will be an equal number of patients in both groups.The study is being funded by Cancer Research UK and has a phase II component to assess whether recruitment is feasible before moving to a phase III study. 570 patients will be recruited for the study.

• REC name

  North East - Newcastle & North Tyneside 1 Research Ethics Committee

• REC reference

  11/NE/0228

• Date of REC Opinion

  15 Sep 2011

• REC opinion

  Further Information Favourable Opinion