Primary HyperparathyroidismNCT07812649
NIRAF-camera Versus Conventional Surgery in Preoperative Imaging Negative Primary Hyperparathyroidism
A study testing NIRAF-camera in people with Primary Hyperparathyroidism, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Hyperparathyroidism
- What is being tested?
- NIRAF-camera
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2026to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with primary hyperparathyroidism
- Undergoing bilateral neck exploration
- Will under go only parathyroidectomy surgery
Who cannot join
- Diagnosed with secondary or tertiary hyperparathyroidism
- Undergoing focal PG exploration
- Will undergo concomitant surgery (total thyroidectomy, thyroid lobectomy)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Chaise Brewer, 216-672-2131, brewerc3@ccf.org
Eren Berber
About this study
Official title: Outcomes of Parathyroidectomy Using NIRAF-camera Versus Conventional Surgery in Patients With Preoperative Imaging Negative Primary Hyperparathyroidism: A Randomized Controlled Trial
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.
Read more
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
- Being tested
- NIRAF-camera
- Medical subject headings
- Hyperparathyroidism, Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRAF-cameraOther
Near-infrared autofluorescence (NIRAF) camera as an adjunctive tool used for intraoperative identification of abnormal parathyroid glands.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Parathyroidectomy (without NIRAF-camera) | No intervention | Not described |
| Parathyroidectomy with NIRAF-camera | Active comparator | Not described Receives: Other: NIRAF-camera |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gland detection time
Measured: intraoperative
Secondary outcomes (2)
Cure rates
Measured: 2 weeks and 6 months post-op
Number of Frozen Sections
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start31 Aug 2026
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary HyperparathyroidismStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chaise Brewer, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07812649
- Sponsor's protocol ID
- 26-400
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Parathyroidectomy Using NIRAF-camera Versus Conventional Surgery in Patients With Preoperative Imaging Negative Primary Hyperparathyroidism: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07812649
- Acronym / sponsor ID
- 26-400
- Conditions
- Primary Hyperparathyroidism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 31 Aug 2026 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Parathyroidectomy (without NIRAF-camera) | No intervention | – |
| Parathyroidectomy with NIRAF-camera | Active comparator | Other: NIRAF-camera |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with primary hyperparathyroidism
- Undergoing bilateral neck exploration
- Will under go only parathyroidectomy surgery
Key exclusion criteria (3 listed)
- Diagnosed with secondary or tertiary hyperparathyroidism
- Undergoing focal PG exploration
- Will undergo concomitant surgery (total thyroidectomy, thyroid lobectomy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIRAF-cameraNear-infrared autofluorescence (NIRAF) camera as an adjunctive tool used for intraoperative identification of abnormal parathyroid glands. | Other | Parathyroidectomy with NIRAF-camera |
Primary outcome
Gland detection time
Time frame: intraoperative
2 secondary outcomes
Cure rates
Time frame: 2 weeks and 6 months post-op
Number of Frozen Sections
Time frame: intraoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
Related trials for Primary Hyperparathyroidism
Enrolling by invitationObservational study
Parathyroid Adenoma Detection With Rubidium-82 Imaging
Parathyroid Adenomas, Hyperparathyroidism, Primary
RecruitingPhase 4
Bisphosphonate Prior to Parathyroidectomy in Primary Hyperparathyroidism
Primary Hyperparathyroidism
Not yet recruitingObservational study
Osteoporosis & Renal Disease: Research in Primary Health Care Services
Osteoporosis, Chronic Kidney Disease Mineral and Bone Disorder
RecruitingObservational study
Evaluation of the Role of Luteinizing Hormone (LH) and Human Chorionic Gonadotropin (hCG) in Adult Patients Undergoing Assessment for Endocrine Disorders
Osteoporosis, Hypercalcemia
RecruitingObservational study
Natural History Study of Parathyroid Disorders
Parathyroid Cancer, Primary Hyperparathyroidism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIRAF-camera in people with Primary Hyperparathyroidism, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gland detection time (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.