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

NCT07812649 | Recruiting

• 1 other identifier: 26-400
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Primary Hyperparathyroidism

Outcome Measures

Primary Outcomes (1)

• Gland detection time

  intraoperative

Secondary Outcomes (2)

• Cure rates

  2 weeks and 6 months post-op

• Number of Frozen Sections

  intraoperative

Study Arms (2)

Conventional Parathyroidectomy (without NIRAF-camera)

NO INTERVENTION

Parathyroidectomy with NIRAF-camera

ACTIVE COMPARATOR

Other: NIRAF-camera

Interventions

NIRAF-camera OTHER

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

Parathyroidectomy with NIRAF-camera

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with primary hyperparathyroidism
• Undergoing bilateral neck exploration
• Will under go only parathyroidectomy surgery

You may not qualify if:

• Diagnosed with secondary or tertiary hyperparathyroidism
• Undergoing focal PG exploration
• Will undergo concomitant surgery (total thyroidectomy, thyroid lobectomy)

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Hyperparathyroidism, Primary

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Coordinator

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 10, 2026
• Study Start: August 31, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: September 11, 2026

Record last verified: 2026-09

Locations

US (1)