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NCT Number: NCT07068867

Upfront Ultrasound for Preoperative Localization in Primary Hyperparathyroidism

Primary hyperparathyroidism is caused by overactive parathyroid glands, leading to elevated calcium levels in the blood. The standard preoperative imaging includes both a radiation-based imaging modality and conventional ultrasound. However, ultrasound alone is a faster, safer, and more patient-friendly alternative. This study evaluates an upfront ultrasound approach, where patients undergo ultrasound first, and only those with certain findings proceed directly to surgery without additional imaging. Patients with uncertain findings proceed to additional imaging. The study is designed as a prospective cohort with a non-inferiority analysis, aiming to confirm whether upfront ultrasound can achieve an acceptable diagnostic sensitivity. If successful, this approach could reduce patient burden, minimize radiation exposure, and optimize healthcare resources

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Key information

Conditions

Primary Hyperparathyroidism Endocrine System Diseases Hyperparathyroidism Hyperparathyroidism, Primary Parathyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Odense University Hospital

Odense, 5000, Denmark

About this study

This study evaluates the implementation of a stepwise approach using upfront ultrasound for localizing pathological parathyroid glands in patients with primary hyperparathyroidism (PHPT).

PHPT is caused by overactive parathyroid glands, leading to excessive amounts of calcium in the blood, which can result in complications such as kidney stones, osteoporosis, cardiovascular disease, and neurological symptoms. The standard preoperative imaging process currently includes both nuclear medicine scans and ultrasound. However, nuclear imaging is time-consuming, exposes patients to radiation, and may not always provide definitive results.

The proposed approach prioritizes ultrasound as the initial localization tool, with additional imaging reserved for cases where ultrasound findings are inconclusive. This method has the potential to reduce unnecessary hospital visits, minimize radiation exposure, and streamline the diagnostic process. The study aims to ensure that this approach maintains high sensitivity for the localization of pathological parathyroid glands, with a target sensitivity of at least 89.5% for correctly identifying diseased parathyroid glands.

Designed as a prospective cohort study, the project will assess patients using ultrasound first, assigning confidence scores (0-3) to determine whether further imaging is necessary. A confidence-score of 3 indicates a high diagnostic confidence. To gain a score of 3, the potential parathyroid adenoma must meet all predefined criteria, i.e. hypoechogenicity, well-defined margins, location at the anatomically expected position, a polar feeding vessel, and a vascular arc. A diagnostic-score of 2 reflects moderate suspicion, where one or two of these key features are missing. A diagnostic-score of 1 suggests low suspicion, typically characterized by a poorly defined structure with no vascular features. Finally, a diagnostic-score of 0 means that no potential adenoma was detected.

Postoperative findings will confirm the accuracy of the preoperative imaging with the histopathological result of the surgically removed specimen(s) combined with biochemical cure at 6 months as the reference standard.

The study aims to benefit both patients and society as it intends to decrease patient exposure to radiation, reduce costs, and reduce the time patients have to take off from work for the purpose of preoperative imaging. One less hospital visit will also reduce the pollution caused by an extra day of transportation to and from the hospital.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients 18 years and older with primary hyperparathyroidism referred to the Department of ORL, Head and Neck Surgery at Odense University Hospital for parathyroidectomy.

Exclusion criteria

  • Other causes of hypercalcemia
  • Persistent or recurrent hyperparathyroidism.
  • Previous surgery to the thyroid or the parathyroid glands.
  • Inability to read/speak Danish

Treatment and study plan

Primary outcomes

  1. Sensitivity of the sequential imaging regimen (upfront ultrasound)

    Time frame: No residual disease 6 months after surgery

    The primary outcome measure is the sensitivity of the sequential imaging regimen (upfront ultrasound) for localizing one or more pathological parathyroid glands to the correct quadrant of the neck. The reference standard is histopathology combined with biochemical cure.

Secondary outcomes

  1. Primary outcome re-calculated for a theoretical cut-off at "diagnostic confidence score = 2"

    Time frame: No residual disease 6 months after surgery

    The primary endpoint re-calculated with a theoretical cut-off at "diagnostic confidence score=2" as the criteria that leads to surgery without additional imaging.

  2. Primary outcome re-calculated for a theoretical cut-off at "diagnostic confidence score = 1"

    Time frame: No residual disease 6 months after surgery

    The primary endpoint re-calculated with a theoretical cut-off at "diagnostic confidence score=1" as the criteria that leads to surgery without additional imaging.

  3. Per gland sensitivity, specificity, positive and negative predictive value of the sequential imaging regimen

    Time frame: 6 months after surgery

    Per gland sensitivity, specificity, positive and negative predictive value of the sequential imaging regimen

  4. Patients that didn't need supplementary imaging

    Time frame: 6 months post-surgery

    Fractions of patients that didn't need supplementary imaging.

  5. Surgery duration

    Time frame: Immediately after surgery

    Discrepancy between expected and actual duration of surgery.

  6. Unnecessary supplementary imaging

    Time frame: 6 months post-surgery

    Fraction of unnecessary supplementary imaging

  7. Unnecessarily explored quadrants

    Time frame: 6 months post-surgery

    Number of unnecessarily explored quadrants

  8. Complication rate

    Time frame: From surgery until one year after surgery

    Complication rate in terms of recurrent nerve paralysis, post-operative hemorrhage, or permanent hypoparathyroidism

  9. Cure rate

    Time frame: No residual disease 6 months after surgery

    No hyperparathyroid hypercalcemia

  10. Cost

    Time frame: Through study completion, from baseline to 6 months post-surgery

    Cost of ultrasound, parathyroid scintigraphy and parathyroid choline PET/CT

  11. Confounding

    Time frame: Baseline to 6 months post-surgery

    Is the sensitivity influenced by differences in patient age, sex, BMI, adenoma weight, adenoma depth, adenoma diameter, multiple gland disease, preoperative ionized calcium and preoperative PTH?

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Official study title

A Protocolled Implementation of Upfront Ultrasound (Sequential Pre-operative Imaging) in Primary Hyperparathyroidism in the Region of Southern Denmark

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 16, 2025
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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