Hyperparathyroidism, PrimaryWHITE CAP-PTSNCT07043010
WHITE CAP: Intra-operative Parathyroid Tissue Sensor (PTS)-Guided Assessment of Parathyroid Viability and Surgical Decision-Making
A study testing Near-Infrared Parathyroid Tissue Sensor Imaging (PTS), Rim-Preservation Technique and En-bloc Resection Technique in people with Hyperparathyroidism, Primary and Parathyroid Neoplasms, run by Fujian Medical University at 1 site in China.
Trial summary
Primary hyperparathyroidism is usually cured by removing the single over-active parathyroid adenoma. During surgery, however, surgeons often see a thin rim of normal parathyroid tissue that still "glows" under a near-infrared parathyroid tissue sensor (PTS). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hyperparathyroidism, Primary, Parathyroid Neoplasms, Parathyroid Adenoma
- What is being tested?
- Near-Infrared Parathyroid Tissue Sensor Imaging (PTS), Rim-Preservation Technique and En-bloc Resection Technique
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 31 Dec 2029
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 75 years, able to give informed consent.
- Biochemically proven primary hyperparathyroidism (elevated serum calcium and inappropriately high PTH).
- Pre-operative imaging (sestamibi scan, 4-phase CT, or ultrasound) concordant with a single parathyroid adenoma.
- Planned minimally invasive parathyroidectomy using near-infrared parathyroid tissue sensor (PTS) guidance.
Who cannot join
- Multiple endocrine neoplasia (MEN 1 or 2) or suspicion of multi-gland disease (>1 enlarged gland on imaging).
- Prior parathyroid or extensive neck surgery causing distorted anatomy.
- Need for simultaneous total thyroidectomy or other major neck procedure.
- Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m².
- Pregnancy or breastfeeding.
- Inability to tolerate general anaesthesia or contraindication to intra-operative PTS imaging.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Bo Wang Porfessor, MD, +13959123550, wangbo@fjmu.edu.cn
Bo Wang MD, Principal Investigator
About this study
Official title: WHITE CAP Trial: Optical Parathyroid Tissue Sensor-Guided Assessment of Parathyroid Viability and Its Impact on Clinical Decision-Making
Primary hyperparathyroidism is usually cured by removing the single over-active parathyroid adenoma. During surgery, however, surgeons often see a thin rim of normal parathyroid tissue that still "glows" under a near-infrared parathyroid tissue sensor (PTS). It is unclear whether keeping this tissue in place helps preserve hormone function or whether it leaves behind cells that could become over-active again.
The WHITE CAP study will compare two common surgical choices:
Read more
Preservation strategy - the surgeon removes only the adenoma and leaves the glowing rim of normal tissue untouched.
En-bloc strategy - the surgeon removes the adenoma together with the glowing rim; if too little parathyroid tissue remains, a small fragment is transplanted into the forearm muscle.
About 120 adult patients who have a single parathyroid adenoma will be randomly assigned (like tossing a coin) to one of the two strategies. All operations will use the same FDA-cleared PTS camera that shows the glands in real time without dye or radiation.
The main question is whether preserving the normal rim lowers the rate of temporary low blood-calcium (numbness, tingling) during the first two days after surgery. The study will also check long-term results-blood calcium and parathyroid hormone (PTH) levels, symptoms, and any return of the disease-over two years.
The PTS imaging itself is painless and adds only a few minutes to the operation. Risks are the same as for standard parathyroid surgery, and participants can withdraw at any time without affecting their usual care.
Read the detailed description
Background and Rationale Near-infrared autofluorescence (NIRAF) highlights parathyroid tissue at a wavelength of 820 nm. Several devices, including Fluobeam LX and PTeye®, have FDA 510(k) clearance for intra-operative identification of parathyroid glands. In ~70 % of single-gland disease, NIRAF shows a viable rim of normal tissue partially encasing the adenoma. Retrospective data conflict on whether rim preservation reduces transient hypocalcaemia or increases recurrence. No prospective randomized evidence exists.
Objectives Primary: Compare the incidence of transient hypocalcaemia (albumin-corrected Ca < 2.00 mmol·L-¹ or need for calcium/vit-D supplementation) within 48 h post-operative between preservation and en-bloc strategies.
Secondary: (i) Permanent hypocalcaemia at 6 months; (ii) PTH ≥ 15 pg·mL-¹ at 24 h; (iii) operative time and blood loss; (iv) biochemical or clinical recurrence up to 24 months; (v) correlation of quantitative NIRAF intensity with gland viability.
Study Design Multicentre, parallel-group, 1:1 randomized controlled trial (RCT). Block randomisation (size 4) stratified by centre and baseline vitamin-D status. Total sample 120 participants (60 per arm, includes 10 % attrition). Single-blind: outcome assessors and laboratory staff remain unaware of allocation.
Interventions Preservation arm: After adenoma excision, surgeon confirms NIRAF-positive rim and leaves it in situ; only minimal defatting to ensure vascularity.
En-bloc arm: Adenoma plus NIRAF-positive rim excised en bloc. If fewer than two normal glands remain in the neck, a 30 mg fragment is minced and autotransplanted into the non-dominant brachioradialis.
Eligibility Inclusion: age 18-75 y; biochemically confirmed primary hyperparathyroidism; imaging (MIBI or 4D-CT) concordant with a solitary adenoma; written informed consent.
Exclusion: multiple endocrine neoplasia, >1 enlarged gland on imaging, eGFR < 30, pregnancy, neck re-exploration, planned concomitant total thyroidectomy.
Outcome Assessments Serum Ca, phosphate, Mg, PTH measured pre-op; 6 h, 24 h, 48 h; Day 7; Months 1, 6, 12, 24. Laryngoscopy if voice change occurs. Recurrence defined as Ca above upper limit plus PTH > 65 pg·mL-¹ after Month 12. NIRAF intensity recorded (arbitrary units) using standard ROI software.
Statistical Plan Transient hypocalcaemia expected 30 % in en-bloc vs 10 % in preservation. With α = 0.05, 1-β = 0.80, needs 54 per arm; rounded to 60. Intent-to-treat analysis. Risk ratios with 95 % CI; secondary continuous outcomes by mixed-effects ANCOVA. Interim safety review at 50 % recruitment (O'Brien-Fleming boundary).
Regulatory and Ethics PTS devices are FDA-cleared; study classified as non-significant-risk device research exempt from IDE (21 CFR 812.2(b)). All centres have IRB approval. Data stored in REDCap, anonymised, GDPR-compliant. A three-member DSMB (endocrine surgeon, endocrinologist, biostatistician) will monitor AEs; trial pause if permanent hypocalcaemia exceeds 15 %.
Data Sharing De-identified participant data and analytic code will be available upon reasonable request 6 months after primary publication.
- Being tested
- Near-Infrared Parathyroid Tissue Sensor Imaging (PTS), Rim-Preservation Technique, En-bloc Resection Technique
- Keywords
- Near-Infrared Autofluorescence, Parathyroid Tissue Sensor, Parathyroid Viability, Peri-adenoma Rim Preservation, Intra-operative Imaging, Calcium Homeostasis, PTS Camera
- Medical subject headings
- Hyperparathyroidism, Primary, Parathyroid Neoplasms, Hypocalcemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near-Infrared Parathyroid Tissue Sensor Imaging (PTS)Device
FDA-cleared imager (e.g., Fluobeam LX/PTeye) providing real-time autofluorescence to identify parathyroid tissue during surgery; no dye or radiation.
Rim-Preservation TechniqueProcedure or surgery
Surgical excision of adenoma while leaving the NIRAF-positive rim of normal parathyroid tissue in situ; minimal defatting to ensure perfusion.
En-bloc Resection TechniqueProcedure or surgery
Surgical excision of adenoma together with the surrounding NIRAF-positive rim; autotransplant fragment if < 2 normal glands remain in neck.
| Study group | Role | What they receive |
|---|---|---|
| Arm A - Rim Preservation | Experimental | Participants undergo adenoma removal guided by PTS imaging, with deliberate preservation of the NIR-autofluorescent rim of normal parathyroid tissue. Receives: Device: Near-Infrared Parathyroid Tissue Sensor Imaging (PTS); Procedure: Rim-Preservation Technique |
| Arm B - En-bloc Resection | Active comparator | Participants undergo PTS-guided en-bloc excision of the adenoma plus its NIR-positive rim; parathyroid autotransplantation performed when indicated. Receives: Device: Near-Infrared Parathyroid Tissue Sensor Imaging (PTS); Procedure: En-bloc Resection Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Transient Hypocalcaemia
Proportion of participants whose albumin-corrected serum calcium falls < 2.00 mmol/L or who require oral/IV calcium ± active vitamin D to maintain normocalcaemia within 48 h post-operatively. Blood samples at 6 h, 24 h, and 48 h will be analysed by a blinded central laboratory.
Measured: Baseline to 48 hours after surgery (Post-op Day 0-2)
Secondary outcomes (6)
Permanent Hypocalcaemia
Need for ongoing calcium ± calcitriol to maintain normocalcaemia at ≥ 6 months after surgery.
Measured: 6 months (±14 days) post-op
Parathyroid Hormone (PTH) Recovery ≥ 15 pg/mL
Percentage of patients with serum PTH ≥ 15 pg/mL at 24 h, indicating preserved parathyroid function.
Measured: 24 hours post-op
Operative Time
Skin incision to skin closure, recorded by anaesthesia time stamp.
Measured: Intra-operative (minutes)
Estimated Blood Loss
Calculated from suction canister minus irrigation plus soaked swab weight.
Measured: Intra-operative (mL)
Biochemical or Clinical Recurrence
Recurrence defined as serum calcium above lab upper limit of normal + PTH > 65 pg/mL and/or imaging-confirmed adenoma regrowth.
Measured: 12 to 24 months post-op
Correlation of NIRAF Intensity with PTH Recovery
Spearman correlation between quantitative NIRAF counts (ROI) and 24-h PTH value.
Measured: Intra-op & 24 hours post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperparathyroidism, PrimaryStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, parallel-group (1 : 1) controlled trial comparing preservation of peri-adenoma NIR-positive tissue with en-bloc excision.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Wang,MD, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07043010
- Sponsor's protocol ID
- WHITECAP-PTS
- Acronym
- WHITE CAP-PTS
- Status last verified
- Jun 2025
- First submitted
- 21 Jun 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WHITE CAP Trial: Optical Parathyroid Tissue Sensor-Guided Assessment of Parathyroid Viability and Its Impact on Clinical Decision-Making
- ClinicalTrials.gov ID
- NCT07043010
- Acronym / sponsor ID
- WHITE CAP-PTS / WHITECAP-PTS
- Keywords
- Near-Infrared Autofluorescence, Parathyroid Tissue Sensor, Parathyroid Viability, Peri-adenoma Rim Preservation, Intra-operative Imaging, Calcium Homeostasis, PTS Camera
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 29 Jun 2025 (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 is usually cured by removing the single over-active parathyroid adenoma. During surgery, however, surgeons often see a thin rim of normal parathyroid tissue that still "glows" under a near-infrared parathyroid tissue sensor (PTS). It is unclear whether keeping this tissue in place helps preserve hormone function or whether it leaves behind cells that could become over-active again.
The WHITE CAP study will compare two common surgical choices:
Preservation strategy - the surgeon removes only the adenoma and leaves the glowing rim of normal tissue untouched.
En-bloc strategy - the surgeon removes the adenoma together with the glowing rim; if too little parathyroid tissue remains, a small fragment is transplanted into the forearm muscle.
About 120 adult patients who have a single parathyroid adenoma will be randomly assigned (like tossing a coin) to one of the two strategies. All operations will use the same FDA-cleared PTS camera that shows the glands in real time without dye or radiation.
The main question is whether preserving the normal rim lowers the rate of temporary low blood-calcium (numbness, tingling) during the first two days after surgery. The study will also check long-term results-blood calcium and parathyroid hormone (PTH) levels, symptoms, and any return of the disease-over two years.
The PTS imaging itself is painless and adds only a few minutes to the operation. Risks are the same as for standard parathyroid surgery, and participants can withdraw at any time without affecting their usual care.
Detailed description
Background and Rationale Near-infrared autofluorescence (NIRAF) highlights parathyroid tissue at a wavelength of 820 nm. Several devices, including Fluobeam LX and PTeye®, have FDA 510(k) clearance for intra-operative identification of parathyroid glands. In ~70 % of single-gland disease, NIRAF shows a viable rim of normal tissue partially encasing the adenoma. Retrospective data conflict on whether rim preservation reduces transient hypocalcaemia or increases recurrence. No prospective randomized evidence exists.
Objectives Primary: Compare the incidence of transient hypocalcaemia (albumin-corrected Ca < 2.00 mmol·L-¹ or need for calcium/vit-D supplementation) within 48 h post-operative between preservation and en-bloc strategies.
Secondary: (i) Permanent hypocalcaemia at 6 months; (ii) PTH ≥ 15 pg·mL-¹ at 24 h; (iii) operative time and blood loss; (iv) biochemical or clinical recurrence up to 24 months; (v) correlation of quantitative NIRAF intensity with gland viability.
Study Design Multicentre, parallel-group, 1:1 randomized controlled trial (RCT). Block randomisation (size 4) stratified by centre and baseline vitamin-D status. Total sample 120 participants (60 per arm, includes 10 % attrition). Single-blind: outcome assessors and laboratory staff remain unaware of allocation.
Interventions Preservation arm: After adenoma excision, surgeon confirms NIRAF-positive rim and leaves it in situ; only minimal defatting to ensure vascularity.
En-bloc arm: Adenoma plus NIRAF-positive rim excised en bloc. If fewer than two normal glands remain in the neck, a 30 mg fragment is minced and autotransplanted into the non-dominant brachioradialis.
Eligibility Inclusion: age 18-75 y; biochemically confirmed primary hyperparathyroidism; imaging (MIBI or 4D-CT) concordant with a solitary adenoma; written informed consent.
Exclusion: multiple endocrine neoplasia, >1 enlarged gland on imaging, eGFR < 30, pregnancy, neck re-exploration, planned concomitant total thyroidectomy.
Outcome Assessments Serum Ca, phosphate, Mg, PTH measured pre-op; 6 h, 24 h, 48 h; Day 7; Months 1, 6, 12, 24. Laryngoscopy if voice change occurs. Recurrence defined as Ca above upper limit plus PTH > 65 pg·mL-¹ after Month 12. NIRAF intensity recorded (arbitrary units) using standard ROI software.
Statistical Plan Transient hypocalcaemia expected 30 % in en-bloc vs 10 % in preservation. With α = 0.05, 1-β = 0.80, needs 54 per arm; rounded to 60. Intent-to-treat analysis. Risk ratios with 95 % CI; secondary continuous outcomes by mixed-effects ANCOVA. Interim safety review at 50 % recruitment (O'Brien-Fleming boundary).
Regulatory and Ethics PTS devices are FDA-cleared; study classified as non-significant-risk device research exempt from IDE (21 CFR 812.2(b)). All centres have IRB approval. Data stored in REDCap, anonymised, GDPR-compliant. A three-member DSMB (endocrine surgeon, endocrinologist, biostatistician) will monitor AEs; trial pause if permanent hypocalcaemia exceeds 15 %.
Data Sharing De-identified participant data and analytic code will be available upon reasonable request 6 months after primary publication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, parallel-group (1 : 1) controlled trial comparing preservation of peri-adenoma NIR-positive tissue with en-bloc excision.
| Arm | Type | Receives |
|---|---|---|
| Arm A - Rim Preservation | Experimental | Device: Near-Infrared Parathyroid Tissue Sensor Imaging (PTS), Procedure: Rim-Preservation TechniqueParticipants undergo adenoma removal guided by PTS imaging, with deliberate preservation of the NIR-autofluorescent rim of normal parathyroid tissue. |
| Arm B - En-bloc Resection | Active comparator | Device: Near-Infrared Parathyroid Tissue Sensor Imaging (PTS), Procedure: En-bloc Resection TechniqueParticipants undergo PTS-guided en-bloc excision of the adenoma plus its NIR-positive rim; parathyroid autotransplantation performed when indicated. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 to 75 years, able to give informed consent.
- Biochemically proven primary hyperparathyroidism (elevated serum calcium and inappropriately high PTH).
- Pre-operative imaging (sestamibi scan, 4-phase CT, or ultrasound) concordant with a single parathyroid adenoma.
- Planned minimally invasive parathyroidectomy using near-infrared parathyroid tissue sensor (PTS) guidance.
Key exclusion criteria (6 listed)
- Multiple endocrine neoplasia (MEN 1 or 2) or suspicion of multi-gland disease (>1 enlarged gland on imaging).
- Prior parathyroid or extensive neck surgery causing distorted anatomy.
- Need for simultaneous total thyroidectomy or other major neck procedure.
- Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m².
- Pregnancy or breastfeeding.
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 |
|---|---|---|
| Near-Infrared Parathyroid Tissue Sensor Imaging (PTS)FDA-cleared imager (e.g., Fluobeam LX/PTeye) providing real-time autofluorescence to identify parathyroid tissue during surgery; no dye or radiation. | Device | Arm A - Rim Preservation, Arm B - En-bloc Resection |
| Rim-Preservation TechniqueSurgical excision of adenoma while leaving the NIRAF-positive rim of normal parathyroid tissue in situ; minimal defatting to ensure perfusion. | Procedure or surgery | Arm A - Rim Preservation |
| En-bloc Resection TechniqueSurgical excision of adenoma together with the surrounding NIRAF-positive rim; autotransplant fragment if < 2 normal glands remain in neck. | Procedure or surgery | Arm B - En-bloc Resection |
Primary outcome
Incidence of Transient Hypocalcaemia
Time frame: Baseline to 48 hours after surgery (Post-op Day 0-2)
Proportion of participants whose albumin-corrected serum calcium falls < 2.00 mmol/L or who require oral/IV calcium ± active vitamin D to maintain normocalcaemia within 48 h post-operatively. Blood samples at 6 h, 24 h, and 48 h will be analysed by a blinded central laboratory.
6 secondary outcomes
Permanent Hypocalcaemia
Time frame: 6 months (±14 days) post-op
Parathyroid Hormone (PTH) Recovery ≥ 15 pg/mL
Time frame: 24 hours post-op
Operative Time
Time frame: Intra-operative (minutes)
Estimated Blood Loss
Time frame: Intra-operative (mL)
Biochemical or Clinical Recurrence
Time frame: 12 to 24 months post-op
Correlation of NIRAF Intensity with PTH Recovery
Time frame: Intra-op & 24 hours post-op
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 29 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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 Near-Infrared Parathyroid Tissue Sensor Imaging (PTS), Rim-Preservation Technique and En-bloc Resection Technique in people with Hyperparathyroidism, Primary and Parathyroid Neoplasms, run by Fujian Medical University at 1 site in China.
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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 29 Jun 2025. 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 China. 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?
Contact Bo Wang Professor, MD (+13959123550, wangbo@fjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Transient Hypocalcaemia (time frame: Baseline to 48 hours after surgery (Post-op Day 0-2)). 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 29 Jun 2025.