NIRAF Detection for Thyroid Surgery

Overseen By Tracy S Wang, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Disqualifiers: Parathyroid disease, Enlarged parathyroid, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to locate parathyroid glands during thyroid surgery using near infrared autofluorescence (NIRAF) with a device called PTeye. The researchers aim to determine if this technology makes the surgery safer and more effective than relying solely on the surgeon's eyesight. It targets individuals requiring a total thyroidectomy who do not have parathyroid diseases. Those advised to undergo this type of surgery might be suitable candidates for the trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative surgical advancements that could improve patient safety and outcomes.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this device is safe for identifying parathyroid glands during thyroid surgery?

Research has shown that near-infrared autofluorescence (NIRAF) technology can enhance the safety of thyroid surgery. In one study, NIRAF helped surgeons avoid accidentally removing parathyroid glands in 21% of cases, which is crucial because removing these glands can lead to complications. Another study found that NIRAF outperformed the naked eye in identifying all four parathyroid glands during surgery, reducing the risk of postoperative issues like low calcium levels.

The NIRAF tool used in these trials has already received FDA approval, indicating it has been evaluated for safety in other contexts. While testing in new scenarios remains important, these earlier findings suggest the technology is generally safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the NIRAF Detection Technology for thyroid surgery because it offers a potentially more precise method for identifying parathyroid glands during surgery. Unlike traditional methods that rely solely on the surgeon's visual identification, this technology uses near-infrared autofluorescence (NIRAF) to highlight the parathyroid glands. This could significantly reduce the risk of accidental damage to these glands, which is a common complication during thyroid surgery. By integrating this innovative tool, surgeons hope to improve surgical outcomes and reduce postoperative complications for patients undergoing total thyroidectomy.

What evidence suggests that NIRAF detection technology is effective for identifying parathyroid glands during thyroid surgery?

Research has shown that near-infrared autofluorescence (NIRAF) technology can significantly enhance the identification of parathyroid glands during thyroid surgery. In this trial, one group of participants will undergo parathyroid gland identification with NIRAF detection technology, while another group will rely on the surgeon's visual identification without NIRAF. Surgeons using NIRAF identified 17.9% more parathyroid glands than those using only visual methods. This technology enhances the visibility of the glands, helping to protect their function. In some cases, NIRAF prevented the accidental removal of the parathyroid glands in 21% of surgeries. Overall, NIRAF serves as a valuable tool for making thyroid surgeries safer and more effective. ^{1 2 6 7 8}

Who Is on the Research Team?

Tracy S Wang, MD, MPH

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

This trial is for patients who are set to undergo a complete thyroid removal surgery, with or without lymph node dissection. It's not for those who only need part of their thyroid removed, have parathyroid disease, or find an enlarged parathyroid during surgery.

Inclusion Criteria

I am eligible for or have had a complete thyroid removal surgery.

I am scheduled for or have had a complete thyroid removal.

Exclusion Criteria

I am having part of my thyroid removed.

My enlarged parathyroid was found by accident during thyroid surgery.

I have a condition affecting my parathyroid glands.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo total thyroidectomy with or without lymph node dissection, with or without NIRAF detection technology

Immediate

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for postoperative hypocalcemia and other complications

0-72 hours

In-hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including hypocalcemia and parathyroid function

6 months

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• NIRAF Detection Technology

Trial Overview The study tests NIRAF Detection Technology using the 'Parathyroid Eye (PTeye)' device to see if it helps surgeons better identify parathyroid glands during total thyroidectomy compared to surgeries where this technology isn't used.

How Is the Trial Designed?

Group I: NIRAF Detection Technology (+) Experimental Treatment 1 Intervention

Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).

Group II: NIRAF Detection Technology (-) Active Control 1 Intervention

Parathyroid gland identification will be performed by the surgeon using only visual identification and without using PTeye - NIRAF detection technology in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Vanderbilt University

Collaborator

Trials

714

Recruited

6,143,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2836488

Near-Infrared Autofluorescence for Parathyroid Detection ... During thyroidectomy, surgeons, on average, identified 17.9% more PGs (3.3 per patient) when using NIRAF than the control (2.8 per patient).

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12268529/

Near-Infrared Autofluorescence for Parathyroid Detection ... After using NIRAF, the senior surgeons rated 23.9% as medium and low, and the juniors only rated 13.6% of PGs with medium and low confidence ( ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12432910/

Evaluation of the effectiveness of near-infrared ... Conclusions. Compared to traditional visual recognition, the NIRAF-ICGT integrated technology can help surgeons better identify and protect parathyroid function ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05579782

NCT05579782 | Assessing Benefits of NIRAF Detection for ... It compares risk-benefits and outcomes in patients undergoing total thyroidectomy where NIRAF detection with PTeye for parathyroid identification is either used ...

5. nature.com nature.com/articles/s41598-025-04059-4

Parathyroid glands viability assessment and identification ... Sehnem et al. demonstrated that NIRAF prevented inadvertent parathyroidectomy in 21% of cases, highlighting the importance of reliable PTG ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11175777/

The impact of using near-infrared autofluorescence ... NIRAF is superior to the naked eye in identifying all four PGs during TT. The reduced risk of postoperative hypoparathyroidism and hypocalcemia reflected this ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04299425

Study Details | NCT04299425 | Evaluating Impact of NIRAF ... It compares risk-benefits and outcomes in PTx patients where NIRAF detection with PTeye for parathyroid identification is either used or not used. Detailed ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10836830/

Does the use of probe-based near infrared autofluorescence ... The results of this first randomized clinical trial with probe-based NIRAF detection suggest that this technology could improve parathyroid gland identification ...