PIUR 3D Imaging for Thyroid Nodules

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sarasota Memorial Health Care System

Disqualifiers: Under 22, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new 3D imaging technology called PIUR tUS Infinity Ultrasound to measure thyroid nodules, which are lumps that form in the thyroid gland. The researchers aim to determine if this 3D method is superior and more consistent than the current 2D ultrasound used after procedures that shrink or remove these nodules. Each participant will undergo both imaging methods to compare results. The trial suits patients already planning a thyroid nodule procedure and who are patients of Dr. Ralph Tufano's office. As an unphased trial, it offers patients the chance to contribute to advancing imaging technology for thyroid care.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with your doctor to understand how your medications might interact with the study.

What prior data suggests that this 3D imaging technique is safe for measuring thyroid nodules?

Research has shown that the PIUR tUS Infinity ultrasound system is generally well-received by patients. The FDA has approved its use alongside regular 2D ultrasounds, indicating its safety in assisting doctors with treatment decisions.

The PIUR tUS Infinity aims to improve the measurement of thyroid nodules, which are small lumps in the thyroid. It creates 3D images that provide more detailed information than standard 2D images, helping to reduce errors that might occur when different people take the measurements and ensuring accuracy.

While specific studies on side effects are not mentioned, the FDA's approval suggests it meets certain safety standards. This makes it a promising option for those considering participation in trials using this technology. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about PIUR tUS Infinity for imaging thyroid nodules because it offers a cutting-edge 3D ultrasound technique, which is a significant upgrade from the traditional 2D ultrasound currently used. Unlike standard imaging, which only provides flat images, the 3D approach can capture the full volume of the thyroid nodules, potentially offering more precise measurements and better insights into their structure. This enhanced imaging capability could lead to more accurate diagnoses and improved monitoring of thyroid conditions.

What evidence suggests that PIUR 3D imaging is effective for measuring thyroid nodule volume?

This trial will compare the PIUR tUS Infinity ultrasound system with traditional 2D ultrasound for measuring thyroid nodule size. Research has shown that the PIUR tUS Infinity system holds promise for this purpose. Traditional 2D ultrasound can sometimes lack accuracy and consistency. The PIUR system uses advanced technology to create 3D images, providing more precise measurements. Studies have found that this 3D imaging helps doctors make better treatment decisions by reducing measurement differences between doctors. The FDA has approved the system to assist in treatment decisions when used with 2D imaging, indicating confidence in its effectiveness and reliability compared to the older 2D method. ^{1 3 4 6 7}

Who Is on the Research Team?

Ralph Tufano, MD

Principal Investigator

Sarasota Memorial Health Care Systems

Are You a Good Fit for This Trial?

This trial is for individuals who have undergone thyroid ablation and need their thyroid nodule volume measured. There are no specific inclusion or exclusion criteria provided, so participants may be anyone in this situation.

Inclusion Criteria

Patient of Dr. Ralph Tufano's office

The patient or their legally authorized representative (LAR) must be willing and able to provide informed consent

I am 22 years old or older.

Exclusion Criteria

Pregnancy

Unable to undergo follow-up imaging

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo thyroid nodule ablation followed by imaging with both traditional 2D ultrasound and PIUR 3D ultrasound

1 day

1 visit (in-person)

Follow-up

Participants are monitored for thyroid nodule volume reduction and variability in measurements using both imaging methods

12 months

Visits at baseline, 2 weeks, 1 month, 3 months, 6 months, and 1 year

What Are the Treatments Tested in This Trial?

Interventions

• PIUR tUS Infinity Ultrasound

Trial Overview The study is testing the effectiveness of a new 3D ultrasound technology, PIUR tUS Infinity, against standard 2D ultrasound for measuring thyroid nodule volume after ablation procedures.

How Is the Trial Designed?

Group I: Traditional 2D Experimental Treatment 1 Intervention

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.

Group II: 3D ultrasound using PIUR tUS Infinity Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Sarasota Memorial Health Care System

Lead Sponsor

Trials

5

Recruited

770+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07178080

Comparing a New 3D Technology Used to Measure ... The purpose of this study is to test how effective and consistent the PIUR imaging technology is compared to standard 2D ultrasound in measuring ...

2. piurimaging.com piurimaging.com/post/piur-imaging-launches-piur-tus-infinity-4-for-thyroid-a-new-benchmark-in-tomographic-3d-ultrasound

A New Benchmark in Tomographic 3D Ultrasound ... The PIUR tUS Infinity is an add-on solution for any standard ultrasound system that utilizes innovative sensor technology to provide diagnostic tomographic 3D ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10468465/

Use of 3D ultrasound to characterise temporal changes in ... Thyroid nodules are extremely common, with prevalence rate up to 68%, yet only 7–15% of these are malignant. Many nodules require surveillance ...

4. withpower.com withpower.com/trial/phase-thyroid-nodules-8-2025-717ce

PIUR 3D Imaging for Thyroid Nodules · Info for Participants 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 ...

5. mdpi.com mdpi.com/2072-6694/17/16/2616

Risk Stratification of Thyroid Nodules Using Ultrasound ... The diagnostic accuracy of thyroid nodule risk stratification can be enhanced using different Thyroid Imaging Reporting and Data Systems when comparing the ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf24/K240036.pdf

PIUR Imaging GmbH Jennifer Willner JW Regulatory ... PIUR tUS Infinity is a computer-aided solution to aid in the diagnostic workflow of thyroid and thyroid nodules, including image documentation, ...

7. diagnosticimaging.com diagnosticimaging.com/view/fda-enhanced-3d-ultrasound-platform-thyroid-imaging

FDA Clears Enhanced 3D Ultrasound Platform for Thyroid ... The Piur tUS Infinity system reportedly reduces operator dependency with ultrasound through upgrading of two-dimensional ultrasound devices ...