Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 8:21 AM
Study NCT ID:
NCT07462351
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-12
First Post:
2026-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
System-integrated Point-of-Care Ultrasound in Breast Cancer Screening
Sponsor:
Region Skane
Organization:
Study Overview
Official Title:
System-integrated Point-of-Care Ultrasound in Breast Cancer Screening
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPRING
Brief Summary:
To assess the feasibility, safety, and clinical performance of community-based breast cancer screening incorporating clinical breast exam and short-termed trained examiners performing AI-supported breast POCUS for triage in limited-resource settings.
Detailed Description:
Following awareness campaign, asymptomatic and symptomatic women are invited to breast cancer screening. The screening intervention consists initially of clinical breast exam (CBE). Those that are positive at CBE or that present with symptoms are further examined with targeted artificial intelligence (AI)-supported breast point-of-care ultrasound (POCUS) on the complaint site. The AI-supported POCUS is performed by clinical nurses or clinical officers that have undergone a short training program and certification process in POCUS examination. In the first stage of the study, the same women will also be examined by an expert on site (breast radiologist). If clinical safety can be determined, the second stage of the study will start in which expert radiologist will not be on site. Ultrasound images will be assessed by breast radiologists that will serve as reference standard (on site in stage 1 and remotely in stage 2). Women positive at POCUS triage (positive ultrasound finding or with predefined alarming clinical symptoms) will be referred to further follow up.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2025-03460 | OTHER_GRANT | The Swedish Research Council | View |