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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
Must not have
Children and minors
Patients with secondary or tertiary hyperparathyroidism
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-72 hours after ptx procedure
Awards & highlights
No Placebo-Only Group

Summary

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.

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am under 18 years old.
Select...
I have been diagnosed with secondary or tertiary hyperparathyroidism.
Select...
I need a total thyroidectomy due to both parathyroid and thyroid disease.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Median number of frozen sections (or PTH aspirate) sent for analysis
Secondary study objectives
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

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: 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.

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
The most common treatments for hyperparathyroidism include surgical removal of the overactive parathyroid glands and pharmacologic management with drugs like calcimimetics. Surgical intervention, often aided by technologies like Near-Infrared Autofluorescence (NIRAF) detection, helps precisely locate and preserve healthy parathyroid tissue while removing hyperactive glands, reducing the risk of hypocalcemia and repeat surgeries. Calcimimetics work by increasing the sensitivity of calcium-sensing receptors on the parathyroid glands, thereby decreasing parathyroid hormone (PTH) secretion. These treatments are crucial for maintaining calcium balance and preventing complications such as bone loss and kidney stones in hyperparathyroidism patients.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,906 Previous Clinical Trials
41,016,689 Total Patients Enrolled
3 Trials studying Hyperparathyroidism
630 Patients Enrolled for Hyperparathyroidism
University of California, San FranciscoLead Sponsor
2,580 Previous Clinical Trials
15,177,390 Total Patients Enrolled
Vanderbilt University Medical CenterOTHER
900 Previous Clinical Trials
939,396 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
~9 spots leftby Jan 2025