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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0-72 hours after ptx procedure

Awards & highlights

Study Summary

This trial will test whether using PTeye can improve patient outcomes and reduce healthcare costs after parathyroid surgeries.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,666 Previous Clinical Trials

40,925,895 Total Patients Enrolled

3 Trials studying Hyperparathyroidism

630 Patients Enrolled for Hyperparathyroidism

University of California, San FranciscoLead Sponsor

2,506 Previous Clinical Trials

15,238,445 Total Patients Enrolled

Vanderbilt University Medical CenterOTHER

857 Previous Clinical Trials

672,083 Total Patients Enrolled

Media Library

Parathyroid Eye (PTeye) (Imaging) Clinical Trial Eligibility Overview. Trial Name: NCT05152927 — N/A

Hyperparathyroidism Research Study Groups: Parathyroid Eye (PTeye), Usual Standard of Care

Hyperparathyroidism Clinical Trial 2023: Parathyroid Eye (PTeye) Highlights & Side Effects. Trial Name: NCT05152927 — N/A

Parathyroid Eye (PTeye) (Imaging) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05152927 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any additional participants being accepted for this research project?

"Clinicaltrials.gov reports that this research project is no longer recruiting participants, having first been publicized on January 10th of 2022 and last edited 27th July 2022. Nevertheless, there are currently 2498 other medical trials with open enrollment windows."

Answered by AI

Recent research and studies

The American Journal of SurgeryJournal

Comparing Intraoperative Parathyroid Identification Based on Surgeon Experience Versus Near Infrared Autofluorescence Detection – A Surgeon-blinded Multi-centric Study

Thomas, Giju, Carmen C. Solórzano, Naira Baregamian, Emmanuel A. Mannoh, Rekha Gautam, Rebecca T. Irlmeier, Fei Ye, et al.. 2021. “Comparing Intraoperative Parathyroid Identification Based on Surgeon Experience Versus Near Infrared Autofluorescence Detection – A Surgeon-blinded Multi-centric Study”. The American Journal of Surgery. Elsevier BV. doi:10.1016/j.amjsurg.2021.05.001.

SurgeryJournal

A Novel Optical Approach to Intraoperative Detection of Parathyroid Glands

McWade, Melanie A., Constantine Paras, Lisa M. White, John E. Phay, Anita Mahadevan-Jansen, and James T. Broome. 2013. “A Novel Optical Approach to Intraoperative Detection of Parathyroid Glands”. Surgery. Elsevier BV. doi:10.1016/j.surg.2013.06.046.

The American Journal of SurgeryJournal

Comparing Intraoperative Parathyroid Identification Based on Surgeon Experience Versus Near Infrared Autofluorescence Detection – A Surgeon-blinded Multi-centric Study

clinicaltrials.govStudy

Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy