- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07360587
Thyroid Artery Embolization for the Treatment of Compressive Goiters. (TAE)
Thyroid Artery Embolization for the Treatment of Compressive Goiters: a Prospective Cohort Study.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Laurent Fradet, MD FRCSC
- Phone Number: 14901 +1-819-346-1110
- Email: Laurent.Fradet@USherbrooke.ca
Study Locations
-
-
Quebec
-
Sherbrooke, Quebec, Canada, J1H5H3
- Recruiting
- Centre Hospitalier Universitaire de Sherbrooke
-
Contact:
- Laurent Fradet, MD FRCSC
- Phone Number: 14901 1-819-346-1110
- Email: Laurent.Fradet@USherbrooke.ca
-
Contact:
- Jaime Alberto Reina, BSc
- Phone Number: 26953 1-819-346-1110
- Email: jaime.alberto.reina.marino@usherbrooke.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Thyroid Artery Embolization
Patients with diagnosis of Goiter with compressive symptoms in which other alternatives lack or are refused by the patient himself.
|
Interruption of blood flow that supplies thyroid nodule using embolization technique.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Follow-ups at 1 week, and 3 months, 6 months and 12 months post-op.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in symptoms after TAE.
Time Frame: Follow-ups at 3 months, 6 months and 12 months post-op.
|
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 :
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 |
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.
|
Evaluate the safety of TAE for the treatment of benign compressive goiter using the Adverse Events report.
|
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.
|
Monitoring of the effect of the intervention with thyroid function tests.
|
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.
|
Describe the effect of the procedure on parathyroid function with PTH and calcium blood levels.
|
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.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Haugen 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.
- Lim 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.
- 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.
- Bonnici 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.
- Xiao 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.
- Galkin 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.
- McDermott MT. Hyperthyroidism. Ann Intern Med. 2020 Apr 7;172(7):ITC49-ITC64. doi: 10.7326/AITC202004070.
- Guan 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.
- Papini 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.
- Khairy 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.
- Guth 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-5830
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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