NIRAF-camera Versus Conventional Surgery in Preoperative Imaging Negative Primary Hyperparathyroidism

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
The Cleveland Clinic
Study ID
NCT07812649
Status
Recruiting
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Conditions

  • Primary Hyperparathyroidism

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NIRAF-camera — OTHER
    Near-infrared autofluorescence (NIRAF) camera as an adjunctive tool used for intraoperative identification of abnormal parathyroid glands.

Study Details

Primary hyperparathyroidism (PHPT) is a prevalent endocrine disorder, with an estimated prevalence of 0.86% in the United States. The only definitive treatment for PHPT is parathyroidectomy. Preoperative localization of abnormal parathyroid glands (PGs) is typically achieved using ultrasound imaging and 99mTc-sestamibi scans, which aid in surgical planning and reducing intraoperative gland detection time and increasing the likelihood of successful gland identification. However, reported cure rates can be as low as 79.5%, because of the challenges in identifying PGs intraoperatively. Near-infrared autofluorescence (NIRAF) imaging has recently emerged as a promising adjunctive tool for intraoperative PG identification, particularly in thyroidectomy and parathyroidectomy procedures. It has been FDA-approved as an adjunctive tool for parathyroid identification. NIRAF imaging distinguishes normal PGs, which typically appear bright and homogeneous, from abnormal PGs, which are dim and heterogeneous (Figure). Previous studies have demonstrated that NIRAF-camera technology enhances PG detection during thyroidectomy, leading to improved surgical outcomes and reduced postoperative hypoparathyroidism rates. However, limited research exists regarding its application in parathyroidectomy procedures, with only a few studies suggesting its potential benefits, such as a reduction in the need for frozen sections. At the Cleveland Clinic, parathyroidectomy procedures are done with or without the use of this NIRAF technology, based on surgeon preference and both approaches are considered as part of standard of care. To date, no study has specifically investigated the use of NIRAF technology in PHPT patients in terms of time to PG detection. Given the challenges associated with localizing abnormal PGs in such cases, further research is warranted to explore the potential of NIRAF imaging in improving surgical outcomes. This is a study, randomizing patients to parathyroidectomy with or without (conventional surgery) NIRAF imaging. Surgeons in the control group (conventional) will not be using the NIRAF camera in the procedures unless he/she/they feel a need to use it based on intraoperative findings and surgeon decision. The conventional surgery patients in whom the surgeon decides to use the camera will continue to be analyzed in the original group, with the intention to treat principle, but these cross overs will be recorded and reported as a data field. Primary Study Aim: To assess whether NIRAF-Camera helps to decrease the gland detection time in PHPT cases. Secondary Study Aim: To evaluate the impact of NIRAF-Camera on post-operative cure rates and number of frozen sections done in PHPT cases.

Key Dates

First listed
Sep 10, 2026
Start date
Aug 31, 2026
Status verified
Sep 2026
Primary completion
Dec 30, 2027
Completion
Dec 30, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • No Intervention: Conventional Parathyroidectomy (without NIRAF-camera)
  • Active Comparator: Parathyroidectomy with NIRAF-camera

Primary Outcome Measure

Gland detection time [ Time Frame: intraoperative ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio44195
Chaise Brewer
[email protected]
216-672-2131
Eren Berber (PRINCIPAL_INVESTIGATOR)

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