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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRoyal Berkshire NHS Foundation Trust

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Thyroid artery embolization

Treatment groups

10 Participants
are divided into 1 treatment group

Sponsors and collaborators

Royal Berkshire NHS Foundation Trust

Lead sponsor

University of Reading

Collaborator