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

Sponsor

International Agency for Research on Cancer (Other)

Overall Status

Recruiting

CT.gov ID

NCT06056843

Collaborator

Malabar Cancer Care Society Kannur, India (Other), Bhabha Atomic Research Centre (BARC), India (Other)

150

Enrollment

Location

Arm

24.7

Anticipated Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Carcinoma in Situ	Other: Triage of clinical breast examination positive women using handheld ultrasound by non-radiologists.	N/A

Detailed Description

More than two million new cases of breast cancer occur each year worldwide. Implementing mammography screening is complex and resource-intensive, making it impractical in resource-limited settings. Clinical breast examination (CBE) has been recommended as an alternative screening option for low- and middle-income countries. Several studies have shown a significant shift towards earlier stage tumours detected by CBE. However, the high false-positive rate and low positive predictive value of CBE expose women to unnecessary and costly further diagnostic procedures, as well as the negative psychological consequences. There is an urgent need for a more accurate, cost-effective and reliable triage technology that can be performed by any healthcare provider.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

This is a single-arm study in which women with a positive clinical breast examination will be triaged using a portable ultrasound device by non-radiologists. The gold standard is mammography, ultrasound and histology if needed.This is a single-arm study in which women with a positive clinical breast examination will be triaged using a portable ultrasound device by non-radiologists. The gold standard is mammography, ultrasound and histology if needed.

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

Evaluation of a Handheld Ultrasound Device to Triage Women With a Positive Clinical Breast Examination by Trained Health Workers and Medical Officers

Actual Study Start Date :

May 9, 2022

Anticipated Primary Completion Date :

Feb 28, 2024

Anticipated Study Completion Date :

May 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention arm Triage of clinical breast examination positive women using handheld ultrasound by non-radiologists.	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.

Arm

Intervention/Treatment

Experimental: Intervention arm

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

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.

Outcome Measures

Primary Outcome Measures

Accuracy of non-radiologist portable ultrasound device for triaging women with positive clinical breast examination [Through study completion, an average of 1 year]
Sensitivity, specificity and positive and negative predictive values of portable ultrasound device to detect breast cancer and carcinoma in situ with repeat clinical breast examination, mammography/ultrasound and/or cytology/core biopsy as the gold standard test.

Secondary Outcome Measures

Agreement between portable ultrasound device and mammography/ultrasound [Through study completion, an average of 1 year]
Agreement between portable ultrasound device and mammography/ultrasound by a radiologist in differentiating malignant and benign solid breast lesions.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Clinical breast examination positive women with no debilitating illness.
Symptomatic women found to be positive on clinical breast examination by nurses/midwives or medical officers.