PTeye Detection for Primary Hyperparathyroidism Surgery

Overseen By Anee Sophia Jackson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

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

Compensation: Varies

Number of Visits: 1

Duration: Immediate

160 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Paul Gauger

Principal Investigator

University of Michigan

Eligibility Criteria

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.

Inclusion Criteria

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

I have primary hyperparathyroidism and will have surgery for it.

Exclusion Criteria

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

I have a condition where my parathyroid glands are overactive.

Pregnant women (Patients with positive pregnancy test results will not be included in the study)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo parathyroidectomy (PTx) with or without the use of the PTeye device for parathyroid gland identification

Immediate

1 visit (in-person, surgical procedure)

Postoperative Recovery

Participants recover from surgery and are monitored for immediate postoperative outcomes

0-72 hours

In-hospital stay

Follow-up

Participants are monitored for safety, effectiveness, and any complications after treatment

6 months

Multiple visits (in-person or virtual)

Treatment Details

Interventions

• PTeye

Trial Overview 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.

Participant Groups

Group I: PTeye Experimental Treatment 1 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 Care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Vanderbilt University

Collaborator

Trials

714

Recruited

6,143,000+