Thyroid artery embolisation to shrink large benign thyroid nodules

Thyroid ARtery Goitre Embolization Trial: A Service Introduction and Safety Assessment

This pilot will try thyroid artery embolisation — a minimally invasive catheter procedure — to shrink large non-cancerous thyroid nodules and relieve symptoms in adults who cannot or prefer not to have surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Royal Berkshire NHS Foundation Trust (Government)
• Locations: 1 site (Reading)
• Trial ID: NCT07046546 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with symptomatic or cosmetically distressing benign nodular goitre (TIRADS 1–3 with required FNA confirmation), including selected patients with hyperthyroidism or Graves disease and those unsuitable for or wishing to avoid surgery, are the intended candidates.

Not a fit: Patients with suspicious or malignant nodules, abnormal neck lymph nodes, or those who are good candidates for standard treatments like surgery or radioiodine are unlikely to benefit from this procedure.

Why it matters

Potential benefit: If successful, TAE could shrink large nodules, reduce neck pressure and cosmetic concerns, improve thyroid function where relevant, and allow some patients to avoid surgery or lifelong medication.

How similar studies have performed: Small series from European thyroid centres report TAE is generally safe and can shrink glands by about 40–70% and improve symptoms and hyperthyroidism, but high-quality, larger studies are lacking and it has not been evaluated in the UK.

Eligibility criteria

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 this trial is running

Reading

• Royal Berkshire Hospital — Reading, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Farhan Ahmad

Conditions Thyroid Nodule; Graves Disease; Goitre; Thyroid artery embolisation; Benign thyroid nodules