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A study to evaluate the effectivity of Portable Ultrasound Device in differentiating benign and malignant disease in patients with palpable breast lump

Evaluation of a portable ultrasound device to triage the women positive on clinical breast examination by trained healthcare workers and medical officers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/03/050522
Enrollment
100
Registered
2023-03-09
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: Portable ultrasound device to triage women positive on clinical breast examination: Frequency: 7.5-11 MHz. Machines are new (less than 6 months old). Duration of use during examination

Sponsors

International Agency for Research on Cancer (World Health Organization)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Women positive on CLinical Breast Examination

Exclusion criteria

Exclusion criteria: Women with debilitating illness

Design outcomes

Primary

MeasureTime frame
To evaluate the agreement between PUD and mammography /ultrasound by a radiologist in differentiating malignant and benign solid breast lesionsTimepoint: Recruitment of women: 18 months, Outcome data assessment and analysis: at the end of 18 months.—

Secondary

MeasureTime frame
To collect annotated images of breast ultrasound for future development of artificial algorithm in breast cancer detectionTimepoint: Recruitment of women: 18 months, Outcome data assessment and analysis: at the end of 18 months.;To develop a diagnostic algorithm that incorporates PUD in the triage of breast lumps detected on CBE to avoid unnecessary imaging and biopsy procedures for benign lumpsTimepoint: Recruitment of women: 18 months, Outcome data assessment and analysis: at the end of 18 months.—

Countries

India

Contacts

Public ContactDiptendra Kumar Sarkar

IPGMER, Kolkata

diptendra3@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026