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

80 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests if using a special light device called PTeye during thyroid surgery helps doctors see and protect important glands, reducing complications like low calcium levels.

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 data supports the effectiveness of the treatment NIRAF Detection Technology for thyroid surgery?

Research shows that using NIRAF Detection Technology during thyroid surgery can significantly reduce the risk of low calcium levels after surgery, as it helps surgeons better identify and protect important glands near the thyroid. ^{1 2 3 4 5}

Is NIRAF Detection for Thyroid Surgery safe for humans?

The available research on thyroid surgery indicates that it is generally safe when performed by experienced surgeons, with low rates of serious complications. However, specific safety data for NIRAF Detection Technology in humans is not provided in the available studies. ^{6 7 8 9 10}

How does NIRAF Detection Technology differ from other treatments for thyroid surgery?

NIRAF Detection Technology is unique because it uses near-infrared autofluorescence to help surgeons identify and preserve important structures during thyroid surgery, potentially reducing complications. This approach is different from traditional methods that rely on visual and tactile cues, offering a more precise way to avoid damaging critical tissues. ^{11 12 13 14 15}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Intraoperative near-infrared autofluorescence imaging for hypocalcemia risk reduction after total thyroidectomy: Evidence from a meta-analysis. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Near-Infrared Autofluorescence Imaging in Thyroid Surgery: A Systematic Review and Meta-Analysis. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Preliminary experience with the EleVision IR system in detection of parathyroid glands autofluorescence and perfusion assessment with ICG. [2023]

4. Australia pubmed.ncbi.nlm.nih.gov

Influence of Single Experience with Intraoperative Near-Infrared Autofluorescence on Postoperative Parathyroid Insufficiency after Thyroidectomy - A Preliminary Clinical Study. [2022]

5. Japan pubmed.ncbi.nlm.nih.gov

Real-time intraoperative near-infrared autofluorescence imaging to locate the parathyroid glands: A preliminary report. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Litigation in thyroid surgery: a pan-specialty review of National Health Service (UK) data. [2023]

7. Spain pubmed.ncbi.nlm.nih.gov

[Results of multinodular goiter surgery]. [2006]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Risk Factors for New Onset Atrial Fibrillation during Thyroid Gland Surgery. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Thyroidectomy: post-operative care and common complications. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Six-Year Experience With Endoscopic Thyroidectomy: Outcomes and Safety Profile. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Clinical Application of C-TIRADS Category and Contrast-Enhanced Ultrasound in Differential Diagnosis of Solid Thyroid Nodules Measuring ≥1 cm. [2022]

12. England pubmed.ncbi.nlm.nih.gov

New technologies in thyroid cancer surgery. [2014]

13. Italy pubmed.ncbi.nlm.nih.gov

New applications of thyroid and parathyroid ultrasound. [2016]

14. United States pubmed.ncbi.nlm.nih.gov

Ultrasound imaging in thyroid nodule diagnosis, therapy, and follow-up: Current status and future trends. [2023]

15. Germany pubmed.ncbi.nlm.nih.gov

[Color doppler ultrasonographic detection of focal thyroid nodules]. [2016]