What side effects are associated with this type of intervention?

The primary treatment for hyperparathyroidism is surgical removal of the overactive parathyroid glands. Common side effects of parathyroidectomy include hypocalcemia, which can cause symptoms like tingling, muscle cramps, and in severe cases, cardiac issues. There is also a risk of damage to the recurrent laryngeal nerve, leading to hoarseness or voice changes. General surgical risks such as infection, bleeding, and anesthesia-related complications are also present.

What prior FDA approvals exist?

The FDA has approved several treatments for hyperparathyroidism, primarily focusing on surgical interventions such as parathyroidectomy. Traditional methods include the use of intraoperative parathyroid hormone (PTH) monitoring to ensure the complete removal of hyperactive glands. While the PTeye study explores Near-Infrared Autofluorescence Detection to improve surgical outcomes, there are no specific FDA-approved drugs or technologies directly analogous to this method. However, the FDA has approved medications like cinacalcet for managing hyperparathyroidism in patients with chronic kidney disease on dialysis, which helps control PTH levels non-surgically.

What other types of research exist?

Promising alternatives to PTeye for hyperparathyroidism treatment include intraoperative parathyroid hormone (PTH) monitoring, which provides real-time feedback on the success of gland removal, and advanced imaging techniques such as 4D-CT and SPECT/CT, which offer precise preoperative localization of parathyroid glands. Additionally, fluorescence-guided surgery using indocyanine green (ICG) dye is emerging as a useful tool for identifying parathyroid tissue intraoperatively.

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Imaging

NIRAF Detection with PTeye for Hyperparathyroidism

N/A

Recruiting

Led By Quan-Yang Duh, MD, FACS

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

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

Must have

Adults (>=18 years old) patients with primary hyperparathyroidism who will be undergoing parathyroid surgery

Adults (>=18 years old) patients with persistent primary hyperparathyroidism after having undergone a failed prior parathyroid surgery who will be undergoing repeat parathyroid surgery

Must not have

Children and minors

Patients with secondary or tertiary hyperparathyroidism

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0-72 hours after ptx procedure

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if PTeye, a light-based tool, can help surgeons find parathyroid glands more easily during surgery. It targets patients with hyperparathyroidism to make surgeries quicker and reduce complications. The tool works by shining light on neck tissues to identify parathyroid glands. PTeye is a clinical prototype that has demonstrated high accuracy for label-free intraoperative parathyroid identification, even in the presence of ambient room lights.

Who is the study for?

This trial is for adults over 18 with primary hyperparathyroidism scheduled for parathyroid surgery, including those needing repeat surgery after a failed first attempt. It excludes pregnant women, patients with secondary or tertiary hyperparathyroidism, concurrent thyroid disease requiring total thyroidectomy, and minors.

What is being tested?

The study tests the PTeye system's effectiveness in identifying parathyroid glands during surgery to potentially shorten operation time, reduce the need for tissue biopsies, lower costs, and decrease chances of follow-up surgeries.

What are the potential side effects?

Since PTeye is a detection device used during surgery rather than a drug or invasive treatment, it does not have side effects like medications do. However, risks may include standard surgical complications.

Eligibility Criteria

Inclusion Criteria

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

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I am an adult with primary hyperparathyroidism scheduled for surgery.

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I am an adult with ongoing hyperparathyroidism after a failed parathyroid surgery.

Exclusion Criteria

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

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I am under 18 years old.

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I have been diagnosed with secondary or tertiary hyperparathyroidism.

Select...

I need a total thyroidectomy due to both parathyroid and thyroid disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0-72 hours after ptx procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0-72 hours after ptx procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-72 hours after ptx procedure for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Median number of frozen sections (or PTH aspirate) sent for analysis

Secondary study objectives

Median duration for intraoperative parathyroid hormone (PTH) to normalize

Median duration of parathyroidectomy (PTx) procedure

Median duration taken to identify first parathyroid gland

+12 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: Parathyroid Eye (PTeye)Experimental Treatment1 Intervention

For patients assigned to the study arm, the surgeon will use the PTeye as an intraoperative tool to identify if a suspect tissue is a parathyroid or not, during the parathyroid surgery.

Group II: Usual Standard of CareActive Control1 Intervention

The surgeon will proceed with the parathyroid surgery 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

The most common treatments for hyperparathyroidism include surgical removal of the overactive parathyroid glands and pharmacologic management with drugs like calcimimetics. Surgical intervention, often aided by technologies like Near-Infrared Autofluorescence (NIRAF) detection, helps precisely locate and preserve healthy parathyroid tissue while removing hyperactive glands, reducing the risk of hypocalcemia and repeat surgeries. Calcimimetics work by increasing the sensitivity of calcium-sensing receptors on the parathyroid glands, thereby decreasing parathyroid hormone (PTH) secretion. These treatments are crucial for maintaining calcium balance and preventing complications such as bone loss and kidney stones in hyperparathyroidism patients.