WHITE CAP: Intra-operative Parathyroid Tissue Sensor (PTS)-Guided Assessment of Parathyroid Viability and Surgical Decision-Making

NCT07043010 | Not Yet Recruiting

• 1 other identifier: WHITECAP-PTS
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Hyperparathyroidism, Primary; Parathyroid Neoplasms; Parathyroid Adenoma; Hypocalcemia

Keywords

Near-Infrared Autofluorescence; Parathyroid Tissue Sensor; Parathyroid Viability; Peri-adenoma Rim Preservation; Intra-operative Imaging; Calcium Homeostasis; PTS Camera

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 48 hours after surgery (Post-op Day 0-2)

Secondary Outcomes (6)

• Permanent Hypocalcaemia

  6 months (±14 days) post-op

• Parathyroid Hormone (PTH) Recovery ≥ 15 pg/mL

  24 hours post-op

• Operative Time

  Intra-operative (minutes)

• Estimated Blood Loss

  Intra-operative (mL)

• Biochemical or Clinical Recurrence

  12 to 24 months post-op

Study Arms (2)

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.

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.

Device: Near-Infrared Parathyroid Tissue Sensor Imaging (PTS); Procedure: En-bloc Resection Technique

Interventions

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.

Arm A - Rim Preservation; Arm B - En-bloc Resection

Rim-Preservation Technique PROCEDURE

Surgical excision of adenoma while leaving the NIRAF-positive rim of normal parathyroid tissue in situ; minimal defatting to ensure perfusion.

Arm A - Rim Preservation

En-bloc Resection Technique PROCEDURE

Surgical excision of adenoma together with the surrounding NIRAF-positive rim; autotransplant fragment if \< 2 normal glands remain in neck.

Arm B - En-bloc Resection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujian Medical University: lead

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

Location

MeSH Terms

Conditions

Hyperparathyroidism, Primary; Parathyroid Neoplasms; Hypocalcemia

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance

Central Study Contacts

Bo Wang Professor, MD

CONTACT

+13959123550; wangbo@fjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Calcium and PTH assays will be processed and adjudicated by blinded laboratory personnel; investigators assessing primary endpoint are unaware of group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director & Head of Thyroid Surgery, Principal Investigator, Clinical Professor

Model Details: Randomized, parallel-group (1 : 1) controlled trial comparing preservation of peri-adenoma NIR-positive tissue with en-bloc excision.

Study Record Dates

• First Submitted: June 21, 2025
• First Posted: June 29, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: June 29, 2025

Record last verified: 2025-06

Locations

CN (1)