Thyroid Artery Goitre Embolization Trial A Pilot Study Investigating Thyroid Artery Embolisation as a Treatment for Large Thyroid Nodules

NCT07046546 | Recruiting

• 1 other identifier: IRAS338447
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Large non-cancerous thyroid nodules (lumps in the thyroid gland) can cause pressure or discomfort in the neck or cosmetic issues. The standard treatment options include radiofrequency ablation, radioactive iodine, and surgery. Not all patients are suitable however for these treatments, some lumps are too large, or the patients are not fit enough for surgery. Thyroid artery embolization (TAE) is a new minimally invasive technique (smaller incisions / cuts and shorter recovery time) performed under light sedation. It is used by other European Thyroid Centres, but it hasn't been used in the UK. Embolization means arteries supplying the thyroid gland are blocked by injecting small occlusive particles, like very fine grains of sand that can get stuck in small spaces, preventing blood from passing through. Blocking the thyroid arteries causes the gland to shrink. This provides symptom relief or controls an overactive gland. We aim to undertake a TAE pilot study to explore the safety of TAE in a UK patient population. We are planning to recruit 10 eligible patients. We will also collect additional data (for example on pain, effectiveness, cost and health related quality of life) to inform a future larger trial comparing TAE to other treatment options.

Conditions

Thyroid Nodule (Benign); Graves Disease; Goitre

Keywords

Thyroid artery embolisation; Benign thyroid nodules

Outcome Measures

Primary Outcomes (1)

• Primary outcome measure

  To undertake thyroid artery embolisation (TAE) pilot study and make a preliminary (non-powered) evaluation of TAE safety. The primary end-point is safe treatment with TAE of 10 patients over an 18 month period.

  18 months

Secondary Outcomes (4)

• Recruitment

  18 months

• Procedural pain

  1 week

• Procedural outcome

  3 and 6 month follow up

• Cost

  24 months

Study Arms (1)

Thyroid artery embolization treatment

EXPERIMENTAL

Patient undergoing thyroid artery embolization

Procedure: Thyroid artery embolization

Interventions

Thyroid artery embolization PROCEDURE

A minimally invasive procedure where one or more thyroid arteries are occluded to shrink the thyroid gland or thyroid nodules

Also known as: TAE

Thyroid artery embolization treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Royal Berkshire NHS Foundation Trust: lead
• University of Reading: collaborator

Study Sites (1)

Royal Berkshire Hospital

Reading, United Kingdom

RECRUITING

MeSH Terms

Conditions

Thyroid Nodule; Graves Disease; Goiter

Condition Hierarchy (Ancestors)

Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Exophthalmos; Orbital Diseases; Eye Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Farhan Ahmad

CONTACT

+441183227936; farhan.ahmad@royalberkshire.nhs.uk

Angelika Kristek

CONTACT

+441183228223; angelika.kristek@royalberkshire.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: July 1, 2025
• Study Start: September 29, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)