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Handheld Ultrasound Device to Triage Women With a Positive Clinical Breast Examination by Trained Non-radiologists

NCT06056843 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-04-03

No results posted yet for this study

Summary

Cross sectional study to evaluate estimate accuracy of portable ultrasound device in correctly differentiating the benign breast lesions from the malignant ones in the women referred with a positive Clinical breast examination (CBE) screening test.

Conditions

Interventions

OTHER

Triage of clinical breast examination positive women using handheld ultrasound by non-radiologists.

Women screened for breast cancer by clinical breast examination (CBE). Those with positive CBE will be triaged by portable ultrasound device by non-radiologists. All recruited women will receive a diagnostic mammography and, if necessary, an ultrasound performed by a radiologist. The radiologist will be blinded to the portable ultrasound device findings. Those with suspected lesions either on mammography or ultrasound will have fine needle aspiration cytology (FNAC) or core biopsy. The women with confirmed diagnosis of breast cancer will be staged and appropriately treated as per the policy of the hospital.

Sponsors & Collaborators

  • Malabar Cancer Care Society Kannur, India

    collaborator UNKNOWN

  • Bhabha Atomic Research Centre (BARC), India

    collaborator UNKNOWN

  • International Agency for Research on Cancer

    lead OTHER

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-09
Primary Completion
2025-06-30
Completion
2025-12-31

Countries

  • India

Study Locations

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Entities

Diseases

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 NCT06056843 on ClinicalTrials.gov