What side effects are associated with this type of intervention?

Common side effects of treatments for parathyroid disease, especially surgical interventions like total thyroidectomy, include hypocalcemia due to inadvertent damage or removal of the parathyroid glands, leading to symptoms such as tingling, muscle cramps, and cardiac issues. Other potential side effects are bleeding, infection, and injury to the recurrent laryngeal nerve, causing hoarseness or voice changes. Enhanced visualization techniques like Near Infrared Autofluorescence (NIRAF) Detection with PTeye aim to reduce these risks by improving the identification and preservation of the parathyroid glands during surgery.

What prior FDA approvals exist?

The FDA has approved several treatments for parathyroid disease, primarily focusing on managing hyperparathyroidism and related conditions. These treatments include medications like cinacalcet, which helps control overactive parathyroid glands, and parathyroid hormone analogs such as Natpara for hypoparathyroidism. While these treatments manage the biochemical aspects of parathyroid disease, the use of Near Infrared Autofluorescence (NIRAF) Detection with PTeye represents a novel approach aimed at improving surgical outcomes by enhancing the visualization of parathyroid glands during procedures like total thyroidectomy. This technique is still under investigation and not yet a standard FDA-approved treatment.

What other types of research exist?

Promising novel alternatives to NIRAF Detection with PTeye for parathyroid disease patients include: 1) Fluorescence-guided surgery using indocyanine green (ICG), which enhances visualization of parathyroid glands through fluorescence imaging. 2) Real-time intraoperative parathyroid hormone (PTH) monitoring, which helps confirm the removal of hyperfunctioning parathyroid tissue. 3) Advanced imaging techniques such as 4D-CT and SPECT/CT, which provide detailed preoperative localization of parathyroid adenomas. These alternatives offer enhanced accuracy and real-time feedback during parathyroid surgery.

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NIRAF Detection with PTeye for Thyroid Surgery

N/A

Recruiting

Led By Paul Gauger

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with thyroid disease who will be undergoing total thyroidectomy (includes patients who have undergone a prior neck exploration for parathyroid disease or other but have an intact thyroid gland)

Patients with persisting thyroid disease and will be undergoing re-operative or completion thyroidectomy

Must not have

Patients with incidental enlarged parathyroid discovered during thyroidectomy procedure

Patients undergoing thyroid lobectomy or partial thyroidectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0 - 72 hours after total thyroidectomy

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if using a special light and device to see parathyroid glands during thyroid surgery is better than relying on the surgeon's eyes alone. It focuses on patients having their thyroid gland removed and aims to make the surgery safer by protecting the parathyroid glands. A new technology in thyroid surgery helps better locate and preserve parathyroid glands.

Who is the study for?

This trial is for patients with thyroid disease scheduled for total thyroidectomy, including those who've had prior neck surgery but still have an intact thyroid. It's not open to pregnant women, those with both parathyroid and thyroid diseases, or if only part of the thyroid is being removed.

What is being tested?

The study tests whether using a device called 'Parathyroid Eye (PTeye)' to detect near infrared autofluorescence (NIRAF) helps surgeons better identify parathyroid glands during complete removal of the thyroid gland compared to surgeon's detection alone.

What are the potential side effects?

Since PTeye is a diagnostic tool rather than a drug, it may not have direct side effects. However, its use could affect surgical outcomes like accidental damage or preservation of parathyroid glands.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have thyroid disease and will have my entire thyroid removed.

Select...

I have ongoing thyroid issues and will have more thyroid surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My enlarged parathyroid was found during my thyroid surgery.

Select...

I am having part of my thyroid removed.

Select...

I have both parathyroid and thyroid disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediate. during total thyroidectomy procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediate. during total thyroidectomy procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediate. during total thyroidectomy procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Duration of calcium and/or Vitamin D supplementation

Frequency of Emergency Room (ER) visits or hospitalization due to low blood calcium within 30 days of surgery

Number of auto-transplanted parathyroid glands

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PTeyeExperimental Treatment1 Intervention

The surgeon will use the PTeye as an intraoperative tool to identify if a suspect tissue is a parathyroid or not, during the total thyroidectomy procedure.

Group II: Standard of CareActive Control1 Intervention

The surgeon will not use the PTeye and will proceed with the total thyroidectomy as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for parathyroid disease include surgical removal of the overactive parathyroid glands (parathyroidectomy) and medications to manage calcium levels. The primary mechanism of action for parathyroidectomy is the direct removal of the hyperfunctioning glands, which immediately reduces the excessive production of parathyroid hormone (PTH) and normalizes calcium levels. Medications, such as calcimimetics, work by mimicking calcium in the blood, thereby reducing PTH secretion. The use of Near Infrared Autofluorescence (NIRAF) detection with PTeye during surgery enhances the visualization of parathyroid glands, ensuring more precise removal and reducing the risk of damaging healthy tissue. This is crucial for patients as it minimizes surgical complications and improves outcomes by ensuring that only the problematic glands are removed.