Pressure-enabled Retrograde Occlusive Therapy With Embolization For Control Of Thyroid Disease (PROTECT Registry): A Multicenter Registry

Overview

About this study

Multi-center registry study to evaluate disease-related quality of life outcomes of thyroid embolization via pressure-enabled delivery (PED-TAE). Additional technical success data on parenchymal volume reduction, thyroid function tests changes and post-procedural complications will be recorded. Data will be collected for patients who have undergone PED-TAE using the TriNav Infusion System at participating sites. The registry study will include up to 10 sites, with Sarasota Memorial Health Care System acting as the lead site responsible for maintaining and monitoring the study database.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

1. Adults, 18 years and older
2. Having undergone PED-TAE using the TriNav Infusion System
3. Meeting one of the following criteria:

1. Documented subclinical and or clinical hyperthyroidism in the presence of a toxic multinodular goiter or a toxic nodule > 20 ml
2. Patients' ineligible or refusing surgery, radio-iodine therapy or percutaneous ablation
3. Non-functioning multinodular goiters or nodule causing compressive symptoms including but not limited to neck pain, dysphagia, stridor, exercise induced dyspnea and/or pressure symptoms
4. Bethesda category 2-3 (benign, or atypia or follicular lesion of undetermined significance) on 2 separate fine-needle aspiration biopsy (FNAB) results with a benign molecular profile with patient declining surgical resection

Exclusion Criteria:

1. Renal insufficiency
2. Unable to tolerate angiography including pregnancy and severe allergy to contrast media
3. Bethesda 4-6 on FNAB (suspicious for follicular neoplasm, suspicious for malignancy, or malignant)
4. <18 years old


Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 5/06/2025. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Jacksonville, Fla.

Mayo Clinic principal investigator

Ricardo Paz-Fumagalli, M.D.

Contact us for the latest status

Rochester, Minn.

Mayo Clinic principal investigator

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More information

Publications

  • Radiofrequency ablation for benign thyroid nodules aims to achieve a volume reduction rate of ≥50%. However, factors that predict treatment success have not been defined in a large-scale study. Read More on PubMed
  • This document provides the new EANM guideline on radioiodine therapy of benign thyroid disease. Its aim is to guide nuclear medicine physicians, endocrinologists, and practitioners in the selection of patients for radioiodine therapy. Its recommendations on patients' preparation, empiric and dosimetric therapeutic approaches, applied radioiodine activity, radiation protection requirements, and patients follow-up after administration of radioiodine therapy are extensively discussed. Read More on PubMed
  • This study investigated the efficacy and safety of transradial access (TRA) thyroid artery embolization (TAE) for patients with large solitary symptomatic benign thyroid nodules. Six patients with a total of six nodules (three men and three women; mean age, 36.3 years; age range, 23-45 years) underwent TRA TAE between October 2021 and June 2022 and were subsequently followed up three months later, and their cases were retrospectively reviewed. The associated complications were recorded during and after TRA TAE. The volume change and nodule-related symptom score on a 10-cm visual analogue scale (VAS) between baseline, 1- and 3-month follow-up was analyzed using Wilcoxon signed-rank test. The technical success rate of the TRA TAE was 100% without conversion to transfemoral access. The mean volume of the nodules decreased between baseline (84.1 mL; range, 46.1-170.5 mL), 1-month (38.8 mL; range, 17.6-91.5 mL; P=0.028) and 3-month (14.8 mL; range, 3.95-26.4 mL; P=0.068) at follow-up after TRA TAE. The mean volume reduction rate was 54.9% (range, 45.2-71.8%) at 1-month follow-up and 81.8% (range, 62.0-92.0%) at 3-month follow-up. The VAS score was reduced at 1-month (P=0.028) and at 3-month follow up (P=0.068). Radial artery spasm (n=1) was noted during TRA TAE, and neck pain (n=5) and voice change (n=1) occurred within 1 week after the procedure and resolved with conservative treatment. No major complications were reported. TRA TAE may be a promising alternative therapy for the management of large solitary thyroid nodules. Read More on PubMed
  • The purpose of treating toxic nodular goitre (TNG) is to reverse hyperthyroidism, prevent recurrent disease, relieve symptoms and preserve thyroid function. Treatment efficacies and long-term outcomes of antithyroid drugs (ATD), radioactive iodine (RAI) or surgery vary in the literature. Symptoms often persist for a long time following euthyroidism, and previous studies have demonstrated long-term cognitive and quality of life (QoL) impairments. We report the outcome of treatment, rate of cure (euthyroidism and hypothyroidism), and QoL in an unselected TNG cohort. Read More on PubMed
  • To investigate the safety and efficacy of thyroid artery embolization (TAE) in the treatment of nodular goiter (NG). Read More on PubMed
  • We evaluated the prevalence and characteristics of thyroid nodules detected by thyroid ultrasound (US) at health checkups and the associated clinical parameters. Read More on PubMed
  • Patient-reported outcomes have become important endpoints in comparative effectiveness research and in patient-centered health care. Valid patient-reported outcome measures detect and respond to clinically relevant changes. The purpose of this study was to evaluate responsiveness of the thyroid-related quality of life (QoL) instrument ThyPRO in patients undergoing relevant clinical treatments for benign thyroid diseases and to compare it with responsiveness of the generic SF-36 Health Survey. Read More on PubMed
  • Familial clustering of goiters mostly with an autosomal dominant pattern of inheritance has repeatedly been reported. Moreover, other environmental and etiologic factors are likely to be involved in the development of euthyroid goiter. Therefore, a multifactorial etiology based on complex interactions of both genetic predisposition and the individuals' environment is likely. Read More on PubMed
  • Thyroid nodules are common and are commonly benign. The reported prevalence of nodular thyroid disease depends on the population studied and the methods used to detect nodules. Nodule incidence increases with age, and is increased in women, in people with iodine deficiency, and after radiation exposure. Numerous studies suggest a prevalence of 2-6% with palpation, 19-35% with ultrasound, and 8-65% in autopsy data. With widespread use of sensitive imaging in clinical practice, incidental thyroid nodules are being discovered with increasing frequency. Ultrasonography is the most accurate and cost-effective method for evaluating and observing thyroid nodules. Current ultrasonography machines are relatively inexpensive, sensitive, and easy to operate. Most endocrinologists are now using ultrasound examination in the initial evaluation of a patient with known or suspected thyroid nodule. The management of thyroid incidentalomas is a matter of controversy. Read More on PubMed
  • To test the hypothesis that during the natural history of sporadic nontoxic goiter (SNG), a diffuse goiter precedes a multinodular goiter with gradual development of autonomous thyroid function. Read More on PubMed
  • In this communication data on the natural history of euthyroid multinodular goitres are presented. From a total group of 140 patients (mean age 54.6 years, 14 men and 126 women; 88 with autonomous, 52 with non-autonomous function), follow-up data were available for 90 patients (mean age 54.0 years, 11 men and 79 women; 64 with autonomous, 26 with non-autonomous function). During follow-up (means: 5.0 years, maximum 12.2 years) transitions in function were seen 15 times; 8 autonomous patients became hyperthyroid after less than 1-7 years. There were 6 transitions from non-autonomy to autonomy and 1 from autonomy to non-autonomy. One patient who demonstrated the whole cycle from non-autonomy through autonomy up to hyperthyrodism is described in more detail. In one patient operated upon because of hyperparathyroidism a follicular carcinoma was found by chance. Mechanical problems were the reason for surgery in 6 patients only, 16 patients were operated upon because of cosmetic reasons (mostly in the early years of the study). Finally, results from 19 TRH tests in 16 autonomous patients suggest that TRH tests in patients with autonomously functioning euthyroid multinodular goitres are not yet redundant. Read More on PubMed
  • This study is concerned with 236 euthyroid individuals living in an area of iodine deficiency, 227 of whom had endemic goitres. In these subjects, autonomy could be suspected owing to an inhomogeneous activity distribution on the thyroid scintigram or a subnormal TSH response to TRH. They complete a total number of 426 investigated individuals. Previously, in 190 separated controls without evidence of autonomy, the reference ranges for the thyroid 99mTc pertechnetate uptake under suppression (TcUs), a measure for the non-suppressible thyroid iodide clearance, and for suppressibility of circumscribed thyroid regions, had been determined. These two parameters obtained by high-resolution quantified scintigraphy were used for an accurate detection of thyroid autonomy among the 236 individuals. Suppression scintigraphy revealed autonomy in 171 patients. delta TSH after TRH was subnormal in 40% of the subjects with abnormal thyroid suppressibility. Prevalence of abnormal suppression was dependent on three factors: patient age, goitre type and estimated thyroid weight. In the total investigated collective, the prevalence of autonomy was 77% in patients with a goitre weight above 50 g. The individuals with abnormal suppression were grouped into four classes of TcUs. In these classes, free thyroxine index (FT4I) and total triiodothyronine (TT3) increased with increasing TcUs, whereas delta TSH decreased. This finding indicates a continuum of different extents of autonomous thyroid function, whereas in the individual patient, the extent can be determined using the pertechnetate uptake under suppression. In addition, FT4I, TT3 and delta TSH in each of the TcUs classes depended on the individual iodine supply.(ABSTRACT TRUNCATED AT 250 WORDS) Read More on PubMed
  • Plummer's disease (autonomous goiter) presents a spectrum of forms, raging from solitary autonomous thyroid nodules to numerous small autonomous areas, and from unequivocal to servere hyperthyroidism. Progression is often very slow, but data on long-term follow up are scare, contradictory and limited to solitary nodules. We re-examined 58 untreated patients on one or more occasions. Follow-up time ranged from 1 to 12 years (average 4 years). There were gross clinical or scintigraphic changes in 13 patients. Three included six euthyroidal patients who became (mildly) hyperthyroid, one with a change from single to numerous "hot spots," and one in which the radionuclide disappeared in one of two separate autonomous areas. Minor changes were seen in 14 patients. Changes occurred irrespective of the scintigraphic pattern. In contrast, progression was very rapid in two of 300 other patients with the disease, leading to fatal thyrotoxic crisis withing three months in one. In another patient, transient hyperthyroidism was documented after excessive iodine administration. It is concluded that patients may be left untreated as long as serious complaints and clinical suspicion of associated malignancy are absent. Read More on PubMed

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