NIRAF Detection with PTeye for Hyperparathyroidism

Recruiting in Palo Alto (17 mi)

Overseen by Quan-Yang Duh, MD, FACS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of California, San Francisco

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Quan-Yang Duh, MD, FACS

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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.

Inclusion Criteria

I am an adult with primary hyperparathyroidism scheduled for surgery.

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

Exclusion Criteria

Pregnant women

I am under 18 years old.

I have been diagnosed with secondary or tertiary hyperparathyroidism.

Treatment Details

Interventions

• Parathyroid Eye (PTeye) (Imaging)

Trial Overview 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.

Participant Groups

Group I: Parathyroid Eye (PTeye) Experimental Treatment 1 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 Care Active Control 1 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.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Suresh Gunasekaran

University of California, San Francisco

Chief Executive Officer since 2022

MBA from Southern Methodist University

Dr. Lukejohn Day

University of California, San Francisco

Chief Medical Officer

MD from Stanford University School of Medicine

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 Medical Center

Collaborator

Trials

922

Recruited

939,000+

Jeffrey R. Balser

Vanderbilt University Medical Center

Chief Executive Officer since 2009

MD and PhD from Vanderbilt University

Rick W. Wright

Vanderbilt University Medical Center

Chief Medical Officer since 2023

MD from University of Missouri-Columbia