Thyroid artery embolisation to shrink large benign thyroid nodules

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot feasibility study will perform thyroid artery embolisation (TAE) at Royal Berkshire Hospital to test safety and practical delivery of the procedure in the UK. Under light sedation, a radiologist will guide a small catheter to the thyroid arteries and inject tiny occlusive particles to block blood flow, causing the gland and nodules to shrink. Eligible adults will have symptomatic or cosmetically concerning benign nodular thyroid disease (TIRADS 1–3 with FNA confirmation) including some patients with hyperthyroidism or Graves disease, and will be followed with imaging and clinical assessments to monitor size change, thyroid function, symptoms and adverse events. As a pilot, the study focuses primarily on safety and feasibility rather than definitive efficacy, and will help design larger trials if promising.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* The participant may enter the study if ALL of the following apply:

  * Adults over 18 years of age willing and able to give informed consent.
  * Symptomatic or cosmetically distressing benign nodular thyroid disease with or without intrathoracic extension and with or without hyperthyroidism. Or auto-immune hyperthyroidism (Graves disease).
  * Single nodular goitre causing local mass effect warranting treatment or multi-nodular goitre
  * TIRADS score 1, 2 and 3 nodules (benign or mildly suspicious) as assessed by ultrasound.
  * FNA confirmed benign disease (x2 FNA Thy2 (benign) result required for TR3 nodules, 1x FNA if nodule classified TR2 or less). FNA performed on most high grade nodule or if equal grade then largest nodule.
  * No enlarged / suspicious neck lymphadenopathy on ultrasound.
  * Patient willing to undergo thyroid nodule embolization in preference to other viable treatment options after discussion with Consultant ENT surgeon and / or Consultant Interventional Radiologist. TAE can also be performed as a bridge to surgery, Radiofrequency ablation or Radioactive iodine. Patients may also be unsuitable or unfit for other treatment options.
  * Patient able to lay on the angiography table flat with one or two pillows, and can lay comfortably with 30 degrees or less of head elevation for a minimum of two hours.

Exclusion Criteria:

* The participant may enter the study if ALL of the following apply:

  * Adults over 18 years of age willing and able to give informed consent.
  * Symptomatic or cosmetically distressing benign nodular thyroid disease with or without intrathoracic extension and with or without hyperthyroidism. Or auto-immune hyperthyroidism (Graves disease).
  * Single nodular goitre causing local mass effect warranting treatment or multi-nodular goitre
  * TIRADS score 1, 2 and 3 nodules (benign or mildly suspicious) as assessed by ultrasound.
  * FNA confirmed benign disease (x2 FNA Thy2 (benign) result required for TR3 nodules, 1x FNA if nodule classified TR2 or less). FNA performed on most high grade nodule or if equal grade then largest nodule.
  * No enlarged / suspicious neck lymphadenopathy on ultrasound.
  * Patient willing to undergo thyroid nodule embolization in preference to other viable treatment options after discussion with Consultant ENT surgeon and / or Consultant Interventional Radiologist. TAE can also be performed as a bridge to surgery, Radiofrequency ablation or Radioactive iodine. Patients may also be unsuitable or unfit for other treatment options.
  * Patient able to lay on the angiography table flat with one or two pillows, and can lay comfortably with 30 degrees or less of head elevation for a minimum of two hours.

Where it's running

• Royal Berkshire Hospital
  Reading, United Kingdom Recruiting

Study contacts

• Study coordinator: Farhan Ahmad
• Email: farhan.ahmad@royalberkshire.nhs.uk
• Phone: +441183227936

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.