[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07178080":3,"trial-entities:NCT07178080":102,"trial-summary:NCT07178080":106},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":41,"secondary_outcomes":53,"sex":54,"minimum_age":55,"maximum_age":56,"healthy_volunteers":15,"eligibility_criteria":57,"std_ages":69,"locations":72,"central_contacts":81,"overall_officials":82,"references":87,"see_also_links":98},"NCT07178080","25-ONC-49","Comparing a New 3D Technology Used to Measure Thyroid Nodule Volume to Standard Ultrasound","Comparative Analysis of PIUR Imaging Technology for Volume Reduction Rate Measurement in Thyroid Nodule Ablations","ENROLLING_BY_INVITATION","2027-09-08","2025-09","2025-09-17","2025-09-08","Sarasota Memorial Health Care System","OTHER",false,"After thyroid ablation procedure, the volume of the thyroid nodule (s) needs to be measured to see how well the procedure worked. Currently, these volumes are measured using traditional 2D ultrasound imaging. However, this approach comes with limitations because of the information 2D images cannot gather and because of differences in these measurements between different doctors. A new ultrasound technology called PIUR 3D imaging offers a novel alternative approach. The system uses advanced technology to create 3D images and can generate automated volume estimates. The PIUR imaging system, PIUR tUS Infinity, has been cleared by the Food and Drug Administration (FDA) to aid in treatment decisions when used alongside traditional 2D ultrasound imaging.\n\nThe purpose of this study is to test how effective and consistent the PIUR imaging technology is compared to standard 2D ultrasound in measuring thyroid nodule volume.","PIUR imaging technology, cleared by the U.S. Food and Drug Administration under 510(k) (K240036), is designed to provide advanced volumetric imaging capabilities to improve accuracy in assessing nodule size and volume reduction. This technology has been validated for clinical use and shown to be equivalent to conventional methods. Currently, PIUR is intended to complement the diagnostic process and should not be used as the sole basis for treatment decisions. Instead, it serves as an adjunct to standard 2D ultrasound imaging.⁸ These features make PIUR a potential candidate for post-ablation monitoring of thyroid nodules, where precision and reproducibility are critical.\n\nThis study aims to compare the volume reduction rates obtained using PIUR imaging against those calculated by an experienced clinician using traditional 2D ultrasound. The findings will help assess whether PIUR offers a more reliable, operator-independent method for evaluating treatment outcomes following thyroid nodule ablation.",[19,20],"Thyroid Nodules","Thyroid Nodule",[22,23,24,25],"thyroid nodules","benign thyroid nodule","benign thyroid nodules","thyroid ablation","INTERVENTIONAL","BASIC_SCIENCE",[29],"NA",{"count":31,"type":32},75,"ESTIMATED",[34],{"type":35,"name":36,"description":37,"armGroupLabels":38},"DEVICE","PIUR tUS Infinity Ultrasound","PIUR imaging technology, cleared by the U.S. Food and Drug Administration under 510(k) (K240036), is designed to provide advanced volumetric imaging capabilities to improve accuracy in assessing nodule size and volume reduction.",[39,40],"3D ultrasound using PIUR tUS Infinity","Traditional 2D",[42,46,49],{"measure":43,"description":44,"timeFrame":45},"Thyroid nodule volumetric measurements","Compare thyroid nodule volumetric measurement readings retrieved from the PIUR 3D ultrasound and the volume calculated from a 2D ultrasound among patients having a thyroid ablation","Will occur at baseline, 2 weeks, 1 month, 3 months, 6 months, and 1 year",{"measure":47,"description":48,"timeFrame":45},"Comparison of variability between measurements","Compare the variability in the thyroid nodule volume measurements between the PIUR 3D ultrasound and the variability calculated from a 2D ultrasound among patients having a thyroid ablation",{"measure":50,"description":51,"timeFrame":52},"Post-ablation thyroid volume reduction rate comparison","Evaluate post-ablation thyroid volume reduction rates at 2 weeks and 1-, 3-, 6-, and 12 months in patients undergoing thyroid ablation and receiving PIUR 3D ultrasounds as compared to standard 2D ultrasounds.","2 weeks, 1-, 3-, 6-, and 12 months.",[],"ALL","22 Years",null,{"inclusion":58,"exclusion":63,"raw_text":68},[59,60,61,62],"22 years old or older","Patient of Dr. Ralph Tufano's office","Undergoing thyroid nodule ablation","The patient or their LAR must be willing and able to provide informed consent",[64,65,66,67],"Under 22 years of age","Unable to undergo follow-up imaging","Pregnancy","Patients may be excluded at the physician's discretion based on their clinical judgement and\u002For if the health or safety of the patient may be potentially impacted by participating in this study.","Inclusion Criteria:\n\n* 22 years old or older\n* Patient of Dr. Ralph Tufano's office\n* Undergoing thyroid nodule ablation\n* The patient or their LAR must be willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Under 22 years of age\n* Unable to undergo follow-up imaging\n* Pregnancy\n* Patients may be excluded at the physician's discretion based on their clinical judgement and\u002For if the health or safety of the patient may be potentially impacted by participating in this study.",[70,71],"ADULT","OLDER_ADULT",[73],{"facility":13,"city":74,"state":75,"zip":76,"country":77,"geoPoint":78},"Sarasota","Florida","34239","United States",{"lat":79,"lon":80},27.33643,-82.53065,[],[83],{"name":84,"affiliation":85,"role":86},"Ralph Tufano, MD","Sarasota Memorial Health Care Systems","PRINCIPAL_INVESTIGATOR",[88,92,95],{"pmid":89,"type":90,"citation":91},"31327158","BACKGROUND","Trimboli P, Castellana M, Sconfienza LM, Virili C, Pescatori LC, Cesareo R, Giorgino F, Negro R, Giovanella L, Mauri G. Efficacy of thermal ablation in benign non-functioning solid thyroid nodule: A systematic review and meta-analysis. Endocrine. 2020 Jan;67(1):35-43. doi: 10.1007\u002Fs12020-019-02019-3. Epub 2019 Jul 20.",{"pmid":93,"type":90,"citation":94},"27098804","Bernardi S, Stacul F, Zecchin M, Dobrinja C, Zanconati F, Fabris B. Radiofrequency ablation for benign thyroid nodules. J Endocrinol Invest. 2016 Sep;39(9):1003-13. doi: 10.1007\u002Fs40618-016-0469-x. Epub 2016 Apr 20.",{"pmid":96,"type":90,"citation":97},"29509871","Durante C, Grani G, Lamartina L, Filetti S, Mandel SJ, Cooper DS. The Diagnosis and Management of Thyroid Nodules: A Review. JAMA. 2018 Mar 6;319(9):914-924. doi: 10.1001\u002Fjama.2018.0898.",[99],{"label":100,"url":101},"U.S. Food and Drug Administration. 510(k) Summary for PIUR Imaging Technology","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fcdrh_docs\u002Fpdf24\u002FK240036.pdf",{"nct_id":4,"conditions":103,"biomarkers":105},[104],"Benign Thyroid Nodule",[],{"nct_id":4,"found":15,"summary":56,"prompt_version":56}]