Thyroid NodulesNCT07178080
Comparing a New 3D Technology Used to Measure Thyroid Nodule Volume to Standard Ultrasound
A study testing PIUR tUS Infinity Ultrasound in people with Thyroid Nodules and Thyroid Nodule, run by Sarasota Memorial Health Care System at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Thyroid Nodules, Thyroid Nodule
- What is being tested?
- PIUR tUS Infinity Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2025to 8 Sep 2027
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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/or if the health or safety of the patient may be potentially impacted by participating in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Sarasota Memorial Health Care System
Sarasota, Florida, 34239
About this study
Official title: Comparative Analysis of PIUR Imaging Technology for Volume Reduction Rate Measurement in Thyroid Nodule Ablations
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.
The 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.
Read the detailed description
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.
This 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.
- Conditions
- Thyroid Nodules, Thyroid Nodule
- Being tested
- PIUR tUS Infinity Ultrasound
- Keywords
- thyroid nodules, benign thyroid nodule, benign thyroid nodules, thyroid ablation
- Medical subject headings
- Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIUR tUS Infinity UltrasoundDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 3D ultrasound using PIUR tUS Infinity | Experimental | Both imaging methods will be used throughout the study, the traditional 2D ultrasound followed by the 3D ultrasound using PIUR tUS Infinity. Volume measurements from each imaging method will be compared to one another. Receives: Device: PIUR tUS Infinity Ultrasound |
| Traditional 2D | Other | Both imaging methods will be used throughout the study, the traditional 2D ultrasound followed by the 3D ultrasound using PIUR tUS Infinity. Volume measurements from each imaging method will be compared to one another. Receives: Device: PIUR tUS Infinity Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Will occur at baseline, 2 weeks, 1 month, 3 months, 6 months, and 1 year
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
Measured: Will occur at baseline, 2 weeks, 1 month, 3 months, 6 months, and 1 year
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.
Measured: 2 weeks, 1-, 3-, 6-, and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start8 Sep 2025
- Primary completion8 Sep 2027 (estimated)
- Study completion8 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- This is a double-blinded prospective study with a crossover design. Patients will serve as their own controls and receive a 2D ultrasound followed by a 3D ultrasound using PIUR technology at baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months. For the traditional 2D ultrasound scan, the physician will perform and interpret the scan to calculate volume reduction rates, following the American Thyroid Association (ATA) Thyroid Nodule Guidelines, which is the current standard of care. The PIUR 3D ultrasound results will be blinded to the physician to avoid bias during follow-up appointments.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sarasota Memorial Health Care System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ralph Tufano, Sarasota Memorial Health Care System
- Investigators
- Ralph Tufano, MD, Principal investigator, Sarasota Memorial Health Care Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07178080
- Sponsor's protocol ID
- 25-ONC-49
- Status last verified
- Sep 2025
- First submitted
- 7 Sep 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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/s12020-019-02019-3. Epub 2019 Jul 20.
PubMed 31327158Bernardi 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/s40618-016-0469-x. Epub 2016 Apr 20.
PubMed 27098804Durante 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/jama.2018.0898.
PubMed 29509871
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of PIUR Imaging Technology for Volume Reduction Rate Measurement in Thyroid Nodule Ablations
- ClinicalTrials.gov ID
- NCT07178080
- Acronym / sponsor ID
- 25-ONC-49
- Conditions
- Thyroid Nodules, Thyroid Nodule
- Keywords
- thyroid nodules, benign thyroid nodule, benign thyroid nodules, thyroid ablation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Sarasota Memorial Health Care SystemUniversity, hospital or other
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- 8 Sep 2027 (estimated)
- Study completion
- 8 Sep 2027 (estimated)
- First posted
- 17 Sep 2025 (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.
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.
The 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.
Detailed description
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.
This 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This is a double-blinded prospective study with a crossover design. Patients will serve as their own controls and receive a 2D ultrasound followed by a 3D ultrasound using PIUR technology at baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months. For the traditional 2D ultrasound scan, the physician will perform and interpret the scan to calculate volume reduction rates, following the American Thyroid Association (ATA) Thyroid Nodule Guidelines, which is the current standard of care. The PIUR 3D ultrasound results will be blinded to the physician to avoid bias during follow-up appointments.
| Arm | Type | Receives |
|---|---|---|
| 3D ultrasound using PIUR tUS Infinity | Experimental | Device: PIUR tUS Infinity UltrasoundBoth imaging methods will be used throughout the study, the traditional 2D ultrasound followed by the 3D ultrasound using PIUR tUS Infinity. Volume measurements from each imaging method will be compared to one another. |
| Traditional 2D | Other | Device: PIUR tUS Infinity UltrasoundBoth imaging methods will be used throughout the study, the traditional 2D ultrasound followed by the 3D ultrasound using PIUR tUS Infinity. Volume measurements from each imaging method will be compared to one another. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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/or if the health or safety of the patient may be potentially impacted by participating in this study.
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 |
|---|---|---|
| PIUR tUS Infinity UltrasoundPIUR 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. | Device | 3D ultrasound using PIUR tUS Infinity, Traditional 2D |
Primary outcome
Thyroid nodule volumetric measurements
Time frame: Will occur at baseline, 2 weeks, 1 month, 3 months, 6 months, and 1 year
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
Comparison of variability between measurements
Time frame: Will occur at baseline, 2 weeks, 1 month, 3 months, 6 months, and 1 year
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
Post-ablation thyroid volume reduction rate comparison
Time frame: 2 weeks, 1-, 3-, 6-, and 12 months.
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.
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 17 Sep 2025.
- Background: PubMed 31327158Trimboli 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/s12020-019-02019-3. Epub 2019 Jul 20.
- Background: PubMed 27098804Bernardi 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/s40618-016-0469-x. Epub 2016 Apr 20.
- Background: PubMed 29509871Durante 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/jama.2018.0898.
- U.S. Food and Drug Administration. 510(k) Summary for PIUR Imaging TechnologyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Ralph Tufano, MD principal investigator
Sarasota Memorial Health Care Systems
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PIUR tUS Infinity Ultrasound in people with Thyroid Nodules and Thyroid Nodule, run by Sarasota Memorial Health Care System at 1 site in United States.
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 4 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 17 Sep 2025. 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 United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thyroid nodule volumetric measurements (time frame: Will occur at baseline, 2 weeks, 1 month, 3 months, 6 months, and 1 year). The study lists 3 primary outcomes in all. 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 NCT07178080, which also lists 3 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 17 Sep 2025.