PTeye Detection for Primary Hyperparathyroidism Surgery

Recruiting in Palo Alto (17 mi)

Overseen by Paul Gauger

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Michigan

No Placebo Group

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)

Treatment Details

Interventions

• PTeye (Procedure)

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+

Marschall S. Runge

University of Michigan

Chief Executive Officer since 2015

MD, PhD

Karen McConnell

University of Michigan

Chief Medical Officer since 2020

MD

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Vanderbilt University

Collaborator

Trials

714

Recruited

6,143,000+

Robert L. Caldwell

Vanderbilt University

Chief Executive Officer since 2003

PhD in Pathology from Vanderbilt University

Rick Wright

Vanderbilt University

Chief Medical Officer since 2023

MD from Washington University School of Medicine in St. Louis