What side effects are associated with this type of intervention?

The most common treatment for Primary Hyperparathyroidism is parathyroidectomy. Known side effects of parathyroidectomy include hypocalcemia, which can cause symptoms such as tingling, muscle cramps, and in severe cases, cardiac arrhythmias. Other potential side effects include damage to the recurrent laryngeal nerve, leading to hoarseness or voice changes, and general surgical risks such as infection and bleeding. The use of Near Infrared Autofluorescence (NIRAF) detection aims to reduce the risk of inadvertently damaging the parathyroid glands, potentially minimizing these side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Primary Hyperparathyroidism, primarily focusing on surgical interventions and medications. Traditional surgical treatment involves parathyroidectomy, where the overactive parathyroid glands are removed. Medications such as calcimimetics (e.g., cinacalcet) are also approved to manage calcium levels in patients who are not candidates for surgery. While Near Infrared Autofluorescence Detection (NIRAF) with devices like the Parathyroid Eye (PTeye) is being studied to improve the identification of parathyroid glands during surgery, specific FDA approvals for NIRAF technology in this context are not detailed in the provided information.

What other types of research exist?

Promising novel alternatives to Parathyroid Eye (PTeye) for Primary Hyperparathyroidism patients include: 1) Fluorescence-guided surgery using indocyanine green (ICG), which enhances visualization of parathyroid glands during surgery. 2) Real-time intraoperative parathyroid hormone (PTH) monitoring, which provides immediate feedback on the success of gland removal. 3) Advanced imaging techniques such as 4D-CT and SPECT/CT, which offer precise preoperative localization of parathyroid adenomas.

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Procedure

PTeye Detection for Primary Hyperparathyroidism 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

Persistent primary hyperparathyroidism after having undergone a failed prior parathyroid surgery who will be undergoing repeat parathyroid surgery

Primary hyperparathyroidism who will be undergoing parathyroid surgery

Must not have

Patients with concurrent parathyroid and thyroid disease that require total thyroidectomy

Patients with secondary or tertiary hyperparathyroidism

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a special light device called PTeye to help doctors see parathyroid glands better during surgery. It targets patients having parathyroid surgery and works by making the glands glow so they are easier to find.

Who is the study for?

This trial is for patients with primary hyperparathyroidism needing parathyroid surgery, especially those who had unsuccessful prior surgeries. It excludes pregnant women, patients requiring total thyroidectomy, and those with secondary or tertiary hyperparathyroidism.

What is being tested?

The study tests if identifying parathyroid glands using a device called 'PTeye' during surgery is more effective than surgeon detection alone. The PTeye uses near infrared autofluorescence (NIRAF) to help surgeons find the glands.

What are the potential side effects?

Since the intervention involves using a detection device rather than a drug, typical side effects are not expected. However, there may be risks associated with potential surgical complications from misidentification of glands.

Eligibility Criteria

Inclusion Criteria

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

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I have ongoing high calcium levels due to parathyroid issues after a failed surgery.

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I have primary hyperparathyroidism and will have surgery for it.

Exclusion Criteria

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

Select...

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

Select...

I have a condition where my parathyroid glands are overactive.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Parathyroid hormone (PTH) levels

Secondary study objectives

Average number of minutes taken to identify first parathyroid gland

Average number of minutes taken to identify last parathyroid gland

Frequency of postoperative (within 30 days) Emergency Room visits or hospitalization

+6 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 parathyroid surgery.

Group II: Standard of CareActive Control1 Intervention

The surgeon will rely solely on her/his surgical experience in identifying the parathyroid glands during the operations.

0 / 4Eligibility 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

Primary Hyperparathyroidism (PHPT) is often treated surgically through parathyroidectomy, where the overactive parathyroid glands are removed. The use of Near Infrared Autofluorescence (NIRAF) detection, such as with the PTeye device, aids surgeons in accurately identifying parathyroid glands during surgery. This technology leverages the natural autofluorescence of parathyroid tissue when exposed to near-infrared light, enhancing the precision of gland identification and reducing the risk of inadvertently damaging or leaving behind hyperactive tissue. Accurate identification is crucial for successful surgery, minimizing complications, and ensuring the complete removal of the problematic glands, which is essential for the effective management of PHPT.