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

Launched by FUJIAN MEDICAL UNIVERSITY · Jun 27, 2025

Keywords

ClinConnect Summary

This clinical trial, called WHITE CAP, is studying the best way to perform surgery for people with primary hyperparathyroidism, a condition where one of the parathyroid glands in the neck is overactive. During surgery to remove the problematic gland (called an adenoma), doctors sometimes see a thin edge of normal parathyroid tissue that still "lights up" when using a special camera called a parathyroid tissue sensor (PTS). The study will compare two approaches: one where the surgeon leaves this glowing rim of normal tissue in place to help keep hormone levels steady, and another where the surgeon removes this rim along with the adenoma and, if needed, transplants a small piece of tissue to the forearm to maintain function.

Adults between 18 and 75 years old with confirmed primary hyperparathyroidism caused by a single adenoma may be eligible to join. Participants can expect a minimally invasive surgery guided by the PTS camera, which is painless and adds only a few minutes to the procedure. The study's main goal is to see if keeping the normal tissue helps prevent low calcium levels and related symptoms like numbness or tingling right after surgery. Participants will be followed for up to two years to check their calcium and hormone levels, symptoms, and whether the condition returns. The risks are similar to standard parathyroid surgery, and joining the study won’t affect usual medical care if someone decides to leave at any time.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.