Thyroid NodulesTAENCT07360587
Thyroid Artery Embolization for the Treatment of Compressive Goiters.
A study testing Thyroid Artery Embolization in people with Thyroid Nodules, run by Centre de recherche du Centre hospitalier universitaire de Sherbrooke at 1 site in Canada.
Trial summary
Very few studies have investigated TAE as a treatment for goiter with compressive symptoms. What is the efficacy and safety of TAE for the treatment of compressive goiters in a population ineligible for or refusing standard therapy? This is a prospective interventional cohort study that will allow us to standardize… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Nodules
- What is being tested?
- Thyroid Artery Embolization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with compressive symptoms or significant tracheal or oesophageal compression at risk of causing symptoms attributed to a goiter AND
- Ineligible for surgery/ablative treatments or preference for TAE over other treatments AND
- TiRADS category 1, 2, 3 or 4 AND
- Bethesda categories I or III on 2 different biopsies OR Bethesda II on one biopsy AND
- Patient at least 18 years old.
Who cannot join
- Comorbidities precluding endovascular procedure OR
- TiRADS category 5 OR
- Bethesda categories IV, V, VI on biopsy OR
- Refusal of the patient to participate OR
- Uncontrolled severe hyperthyroidism OR
- Minor patient.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H5H3
Laurent Fradet, MD FRCSC, 1-819-346-1110 ext. 14901, Laurent.Fradet@USherbrooke.ca
Jaime Alberto Reina, BSc, 1-819-346-1110 ext. 26953, jaime.alberto.reina.marino@usherbrooke.ca
About this study
Official title: Thyroid Artery Embolization for the Treatment of Compressive Goiters: a Prospective Cohort Study.
Very few studies have investigated TAE as a treatment for goiter with compressive symptoms. What is the efficacy and safety of TAE for the treatment of compressive goiters in a population ineligible for or refusing standard therapy? This is a prospective interventional cohort study that will allow us to standardize imaging by improving quality data collection and fellow-up to assess the efficacy of TAE for compressive symptoms of nodular goiters. Not only to corroborate current emerging results but clearly define the expected results for this technique.
Read the detailed description
This study is a prospective interventional cohort study.
The prospective cohort setting allows us to evaluate the direct effect of TAE on a series of patients on a longer period and to strengthen the retrospective data previously documented in other studies.
Included patients will have compressive symptoms or significant tracheal or oesophageal compression at risk of causing symptoms attributed to a goiter.
They have to be Ineligible for surgery/ablative treatments or preference for TAE over other treatments.
There is no comparative group in our study as it aims to prove that TAE is effective and safe in a "nonsurgical" population, a population in which other alternatives lack or are refused by the patient.
Our sampling method will be a non-probabilistic convenience sampling. Patients will be recruited in an outpatient setting by the patient's treating endocrinologist or otolaryngologist.
- Conditions
- Thyroid Nodules
- Being tested
- Thyroid Artery Embolization
- Keywords
- Goiter, Thyroid Artery Embolization, thyroid nodule
- Medical subject headings
- Thyroid Nodule, Goiter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thyroid Artery EmbolizationProcedure or surgery
Interruption of blood flow that supplies thyroid nodule using embolization technique.
| Study group | Role | What they receive |
|---|---|---|
| Thyroid Artery Embolization | Experimental | Patients with diagnosis of Goiter with compressive symptoms in which other alternatives lack or are refused by the patient himself. Receives: Procedure: Thyroid Artery Embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Thyroid nodule volume
TAE effectiveness to reduce overall thyroid and nodular volumes in benign compressive goiters assessing changes in Nodule(s) volume(s) and Thyroid lobe volume.
Measured: Follow-ups at 1 week, and 3 months, 6 months and 12 months post-op.
Secondary outcomes (4)
Change in symptoms after TAE.
Assess the impact of TAE on the symptoms related to the goiter as reported by the patient. Using ThyPRO score.
ThyPRO is designed to evaluate physical, psychological, and social impairments caused by benign thyroid diseases by evaluating :
- Symptom severity
- Functional limitations
- Emotional and social impacts
- This disease-specific focus supports patient-centered care, clinical decision-making, and outcomes research.
- Target Population ThyPRO is validated for adults aged 18 and older with benign thyroid diseases.
The ThyPRO consists of 85 items, grouped into:
13 multi-item domains: Goiter symptoms (11 items) Hyperthyroid symptoms (8) Hypothyroid symptoms (4) Eye symptoms (8) Tiredness (7) Cognitive impairment (6) Anxiety (6), Depressivity (7) Emotional susceptibility (9) Impaired social life (4), daily life (6), and sex life (2) Cosmetic complaints (6)
1 global QoL item Each question is rated on a 5-point Likert scale (0 = Not at all to 4 = Completely
Measured: Follow-ups at 3 months, 6 months and 12 months post-op.
Safety level of TAE in compressive goiter: Adverse Events report
Evaluate the safety of TAE for the treatment of benign compressive goiter using the Adverse Events report.
Measured: Day of embolisation; Follow-ups at 1 week, and 3 months, 6 months and 12 months post-op.
Safety level of TAE in compressive goiter: thyroid function tests
Monitoring of the effect of the intervention with thyroid function tests.
Measured: At baseline visit, approximately 48 hours after the intervention, and 6 weeks, 3 months, 6 months and 12 months after the intervention. More tests can be done according to the treating physician.
Safety level of TAE in compressive goiter: parathyroid function tests
Describe the effect of the procedure on parathyroid function with PTH and calcium blood levels.
Measured: At baseline visit, approximately 48 hours after the intervention, and 6 weeks, 3 months, 6 months and 12 months after the intervention. More tests can be done according to the treating physician.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start1 May 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Thyroid NodulesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is a prospective interventional cohort study. The prospective cohort setting allows us to evaluate the direct effect of TAE on a series of patients on a longer period and to strengthen the retrospective data previously documented in other studies. There is no comparative group in our study as it aims to prove that TAE is effective and safe in a "nonsurgical" population, a population in which other alternatives lack or are refused by the patient.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laurent Fradet, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07360587
- Sponsor's protocol ID
- 2025-5830
- Acronym
- TAE
- Status last verified
- Oct 2026
- First submitted
- 2 Dec 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD information will only be shared after a formal request sent to the principal investigator's email address if the latter considers that the request is legally scientifically justified.
Publications
Ramos HE, Braga-Basaria M, Haquin C, Mesa CO, Noronha Ld, Sandrini R, Carvalho Gde A, Graf H. Preoperative embolization of thyroid arteries in a patient with large multinodular goiter and papillary carcinoma. Thyroid. 2004 Nov;14(11):967-70. doi: 10.1089/thy.2004.14.967.
PubMed 15671777Bonnici M, Nevin C, Boo S. Thyroid ima artery embolization for the treatment of Graves' disease and thyroid storm. Radiol Case Rep. 2023 May 28;18(8):2641-2644. doi: 10.1016/j.radcr.2023.04.044. eCollection 2023 Aug.
PubMed 37273723Xiao H, Zhuang W, Wang S, Yu B, Chen G, Zhou M, Wong NC. Arterial embolization: a novel approach to thyroid ablative therapy for Graves' disease. J Clin Endocrinol Metab. 2002 Aug;87(8):3583-9. doi: 10.1210/jcem.87.8.8723.
PubMed 12161479Galkin EV, Grakov BS, Protopopov AV. [First clinical experience of radio-endovascular functional thyroidectomy in the treatment of diffuse toxic goiter]. Vestn Rentgenol Radiol. 1994 May-Jun;(3):29-35. Russian.
PubMed 7985368McDermott MT. Hyperthyroidism. Ann Intern Med. 2020 Apr 7;172(7):ITC49-ITC64. doi: 10.7326/AITC202004070.
PubMed 32252086Lim HK, Lee JH, Ha EJ, Sung JY, Kim JK, Baek JH. Radiofrequency ablation of benign non-functioning thyroid nodules: 4-year follow-up results for 111 patients. Eur Radiol. 2013 Apr;23(4):1044-9. doi: 10.1007/s00330-012-2671-3. Epub 2012 Oct 25.
PubMed 23096937Guan SH, Wang H, Teng DK. Comparison of ultrasound-guided thermal ablation and conventional thyroidectomy for benign thyroid nodules: a systematic review and meta-analysis. Int J Hyperthermia. 2020;37(1):442-449. doi: 10.1080/02656736.2020.1758802.
PubMed 32369708Papini E, Gugliemi R, Pacella CM. Laser, radiofrequency, and ethanol ablation for the management of thyroid nodules. Curr Opin Endocrinol Diabetes Obes. 2016 Oct;23(5):400-6. doi: 10.1097/MED.0000000000000282.
PubMed 27504993Haugen BR, Alexander EK, Bible KC, Doherty GM, Mandel SJ, Nikiforov YE, Pacini F, Randolph GW, Sawka AM, Schlumberger M, Schuff KG, Sherman SI, Sosa JA, Steward DL, Tuttle RM, Wartofsky L. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid. 2016 Jan;26(1):1-133. doi: 10.1089/thy.2015.0020.
PubMed 26462967Khairy GA. Solitary thyroid nodule: the risk of cancer and the extent of surgical therapy. East Afr Med J. 2004 Sep;81(9):459-62. doi: 10.4314/eamj.v81i9.9221.
PubMed 15626055Guth S, Theune U, Aberle J, Galach A, Bamberger CM. Very high prevalence of thyroid nodules detected by high frequency (13 MHz) ultrasound examination. Eur J Clin Invest. 2009 Aug;39(8):699-706. doi: 10.1111/j.1365-2362.2009.02162.x.
PubMed 19601965
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyroid Artery Embolization for the Treatment of Compressive Goiters: a Prospective Cohort Study.
- ClinicalTrials.gov ID
- NCT07360587
- Acronym / sponsor ID
- TAE / 2025-5830
- Conditions
- Thyroid Nodules
- Keywords
- Goiter, Thyroid Artery Embolization, thyroid nodule
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre de recherche du Centre hospitalier universitaire de SherbrookeUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Very few studies have investigated TAE as a treatment for goiter with compressive symptoms. What is the efficacy and safety of TAE for the treatment of compressive goiters in a population ineligible for or refusing standard therapy? This is a prospective interventional cohort study that will allow us to standardize imaging by improving quality data collection and fellow-up to assess the efficacy of TAE for compressive symptoms of nodular goiters. Not only to corroborate current emerging results but clearly define the expected results for this technique.
Detailed description
This study is a prospective interventional cohort study.
The prospective cohort setting allows us to evaluate the direct effect of TAE on a series of patients on a longer period and to strengthen the retrospective data previously documented in other studies.
Included patients will have compressive symptoms or significant tracheal or oesophageal compression at risk of causing symptoms attributed to a goiter.
They have to be Ineligible for surgery/ablative treatments or preference for TAE over other treatments.
There is no comparative group in our study as it aims to prove that TAE is effective and safe in a "nonsurgical" population, a population in which other alternatives lack or are refused by the patient.
Our sampling method will be a non-probabilistic convenience sampling. Patients will be recruited in an outpatient setting by the patient's treating endocrinologist or otolaryngologist.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is a prospective interventional cohort study. The prospective cohort setting allows us to evaluate the direct effect of TAE on a series of patients on a longer period and to strengthen the retrospective data previously documented in other studies. There is no comparative group in our study as it aims to prove that TAE is effective and safe in a "nonsurgical" population, a population in which other alternatives lack or are refused by the patient.
| Arm | Type | Receives |
|---|---|---|
| Thyroid Artery Embolization | Experimental | Procedure: Thyroid Artery EmbolizationPatients with diagnosis of Goiter with compressive symptoms in which other alternatives lack or are refused by the patient himself. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with compressive symptoms or significant tracheal or oesophageal compression at risk of causing symptoms attributed to a goiter AND
- Ineligible for surgery/ablative treatments or preference for TAE over other treatments AND
- TiRADS category 1, 2, 3 or 4 AND
- Bethesda categories I or III on 2 different biopsies OR Bethesda II on one biopsy AND
- Patient at least 18 years old.
Key exclusion criteria (6 listed)
- Comorbidities precluding endovascular procedure OR
- TiRADS category 5 OR
- Bethesda categories IV, V, VI on biopsy OR
- Refusal of the patient to participate OR
- Uncontrolled severe hyperthyroidism OR
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thyroid Artery EmbolizationInterruption of blood flow that supplies thyroid nodule using embolization technique. | Procedure or surgery | Thyroid Artery Embolization |
Primary outcome
Change in Thyroid nodule volume
Time frame: Follow-ups at 1 week, and 3 months, 6 months and 12 months post-op.
TAE effectiveness to reduce overall thyroid and nodular volumes in benign compressive goiters assessing changes in Nodule(s) volume(s) and Thyroid lobe volume.
4 secondary outcomes
Change in symptoms after TAE.
Time frame: Follow-ups at 3 months, 6 months and 12 months post-op.
Safety level of TAE in compressive goiter: Adverse Events report
Time frame: Day of embolisation; Follow-ups at 1 week, and 3 months, 6 months and 12 months post-op.
Safety level of TAE in compressive goiter: thyroid function tests
Time frame: At baseline visit, approximately 48 hours after the intervention, and 6 weeks, 3 months, 6 months and 12 months after the intervention. More tests can be done according to the treating physician.
Safety level of TAE in compressive goiter: parathyroid function tests
Time frame: At baseline visit, approximately 48 hours after the intervention, and 6 weeks, 3 months, 6 months and 12 months after the intervention. More tests can be done according to the treating physician.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Background: PubMed 15671777Ramos HE, Braga-Basaria M, Haquin C, Mesa CO, Noronha Ld, Sandrini R, Carvalho Gde A, Graf H. Preoperative embolization of thyroid arteries in a patient with large multinodular goiter and papillary carcinoma. Thyroid. 2004 Nov;14(11):967-70. doi: 10.1089/thy.2004.14.967.
- Background: PubMed 37273723Bonnici M, Nevin C, Boo S. Thyroid ima artery embolization for the treatment of Graves' disease and thyroid storm. Radiol Case Rep. 2023 May 28;18(8):2641-2644. doi: 10.1016/j.radcr.2023.04.044. eCollection 2023 Aug.
- Background: PubMed 12161479Xiao H, Zhuang W, Wang S, Yu B, Chen G, Zhou M, Wong NC. Arterial embolization: a novel approach to thyroid ablative therapy for Graves' disease. J Clin Endocrinol Metab. 2002 Aug;87(8):3583-9. doi: 10.1210/jcem.87.8.8723.
- Background: PubMed 7985368Galkin EV, Grakov BS, Protopopov AV. [First clinical experience of radio-endovascular functional thyroidectomy in the treatment of diffuse toxic goiter]. Vestn Rentgenol Radiol. 1994 May-Jun;(3):29-35. Russian.
- Background: PubMed 32252086McDermott MT. Hyperthyroidism. Ann Intern Med. 2020 Apr 7;172(7):ITC49-ITC64. doi: 10.7326/AITC202004070.
- Background: PubMed 23096937Lim HK, Lee JH, Ha EJ, Sung JY, Kim JK, Baek JH. Radiofrequency ablation of benign non-functioning thyroid nodules: 4-year follow-up results for 111 patients. Eur Radiol. 2013 Apr;23(4):1044-9. doi: 10.1007/s00330-012-2671-3. Epub 2012 Oct 25.
- Background: PubMed 32369708Guan SH, Wang H, Teng DK. Comparison of ultrasound-guided thermal ablation and conventional thyroidectomy for benign thyroid nodules: a systematic review and meta-analysis. Int J Hyperthermia. 2020;37(1):442-449. doi: 10.1080/02656736.2020.1758802.
- Background: PubMed 27504993Papini E, Gugliemi R, Pacella CM. Laser, radiofrequency, and ethanol ablation for the management of thyroid nodules. Curr Opin Endocrinol Diabetes Obes. 2016 Oct;23(5):400-6. doi: 10.1097/MED.0000000000000282.
- Background: PubMed 26462967Haugen BR, Alexander EK, Bible KC, Doherty GM, Mandel SJ, Nikiforov YE, Pacini F, Randolph GW, Sawka AM, Schlumberger M, Schuff KG, Sherman SI, Sosa JA, Steward DL, Tuttle RM, Wartofsky L. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid. 2016 Jan;26(1):1-133. doi: 10.1089/thy.2015.0020.
- Background: PubMed 15626055Khairy GA. Solitary thyroid nodule: the risk of cancer and the extent of surgical therapy. East Afr Med J. 2004 Sep;81(9):459-62. doi: 10.4314/eamj.v81i9.9221.
- Background: PubMed 19601965Guth S, Theune U, Aberle J, Galach A, Bamberger CM. Very high prevalence of thyroid nodules detected by high frequency (13 MHz) ultrasound examination. Eur J Clin Invest. 2009 Aug;39(8):699-706. doi: 10.1111/j.1365-2362.2009.02162.x.
- Individual participant dataSharing planned: No. IPD information will only be shared after a formal request sent to the principal investigator's email address if the latter considers that the request is legally scientifically justified.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thyroid Artery Embolization in people with Thyroid Nodules, run by Centre de recherche du Centre hospitalier universitaire de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurent Fradet, MD FRCSC (+1-819-346-1110 ext. 14901, Laurent.Fradet@USherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Thyroid nodule volume (time frame: Follow-ups at 1 week, and 3 months, 6 months and 12 months post-op.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07360587, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.