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Preoperative Localization Strategies in Primary Hyperparathyroidism

NCT04305561 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2022-04-14

No results posted yet for this study

Summary

The purpose of this project is to examine, in a non-inferiority study, whether the combination of conventional ultrasound and contrast-enhanced ultrasound (CEUS) can replace the radiation-based imaging modalities that are currently used to localize pathological parathyroid glands prior to surgical removal in patients with primary hyperparathyroidism.

This will take the form of a prospective paired cohort study where included patients receive a contrast-enhanced ultrasound examination in addition to the standard preoperative imaging regimen (subtraction scintigraphy with SPECT/CT and conventional ultrasound). Patients act as their own controls as all included patients undergo both CEUS and conventional imaging.

Conditions

  • Primary Hyperparathyroidism

Interventions

PROCEDURE

Contrast-enhanced ultrasound

Ultrasound contrast agent: Stabilized sulfur hexafluoride microbubbles (SonoVue®, Bracco). An 18 G needle will be placed in an antecubital vein and directly attached to a three-way stopcock with an extension tube. The SonoVue® will be prepared and shaken shortly before injection in accordance with the instructions provided in the product information leaflet. The patient will be injected with 1.2 ml SonoVue® at a pace of 1-2 ml/s using the 180 degree straight-flow channel of the three-way stopcock, directly followed by a 10 ml bolus of sodium chloride 9 mg/mL (0.9%) injected into the 90 degree channel of the three-way stopcock at a pace of approximately 2 ml/s. A full examination will typically require one to two injections of 1.2 ml of SonoVue® (one injection per suspected parathyroid adenoma).

Sponsors & Collaborators

  • Odense University Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-05
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04305561 on ClinicalTrials.gov