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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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

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

Study 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.

Eligibility

Primary outcome measure(s)

• Incidence of Transient Hypocalcaemia — 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.

Trial sites (1)

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