NCT06722365

Characterization of Fetal Lung With Quantitative Ultrasound

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 16 (estimated)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to show if it's possible to use a special kind of ultrasound called backscatter quantitative ultrasound (bQUS) to check on a baby's lungs when the mother is 36 weeks pregnant. 16 participants will be on study for a single 30 minute ultrasound between 32 and 36 weeks of pregnancy.

Detailed description

Primary Objective: * Demonstrate the feasibility of performing bQUS analysis on ultrasound echo signals acquired of the fetal lung acquired with clinical ultrasound scanners during third -trimester ultrasound scans Secondary Objectives: * Design and implement a protocol to acquire non-processed (raw) echo signals from a commercial ultrasound scanner necessary to perform bQUS at the UPH-Meriter Center for Perinatal Care (CPC). * Quantify the populational variance of quantitative features extracted from bQUS applied to ultrasound data collected from third trimester ultrasound scans of the fetal lung. The study will be divided into two phases: (i) feasibility phase and (2) hypothesis-testing phase recruitment phase. Phase 1 will provide evidence of the technical viability of data acquisition at UPH-Meriter CPC and will involve 5 participants. Technical challenges will be discussed with the research team and the supporting vendor (GE) to decide whether the technique is viable to move forward. In case the decision is favorable, recruitment will continue to complete 16 participants to estimate the populational variance of the quantitative features. If the decision is not favorable due to technical complications, the study will be terminated.

Conditions

• Respiratory Complication
• Fetal Lung Imaging

Interventions

Type	Name	Description
DEVICE	Backscatter Quantitative Ultrasound	The intervention consists of a regular abdominal ultrasound scan for fetal evaluation. The difference with a regular scan is that the scanner used to image the fetus provides access to raw/unprocessed ultrasound echo data that can be extracted from the scanner and processed offline (after acquisition) to extract compute backscatter quantitative ultrasound (bQUS) features. Thus, data acquisition does not represent a significant departure from conventional fetal imaging protocols. Other than the time needed to acquire the images, the participant will not perceive any difference from a regular fetal ultrasound scan.

Timeline

• Start date: 2024-12-17
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2024-12-09
• Last updated: 2026-02-13

Locations

1 site across 1 country: United States