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

Breast Cancer Clinical Trial

— PUD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06056843
• Other study ID #: IEC 21-04
• Status: Recruiting
• Phase: N/A
• Start date: May 9, 2022
• Est. completion date: May 31, 2024

Study information

• Verified date: September 2023
• Source: International Agency for Research on Cancer
• Contact: Farida Selmouni, PhD
• Phone: + 33 4 72 73 84 99
• Email: SelmouniF[@]iarc.who.int
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 31, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 75 Years

Eligibility

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.

Exclusion Criteria:

• Women with confirmed diagnosis of breast cancer or those already treated for the disease.

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma in Situ

Intervention

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.

Locations

Country	Name	City	State
India	Malabar Cancer Care Society Kannur	Kannur

Sponsors (3)

Lead Sponsor	Collaborator
International Agency for Research on Cancer	Bhabha Atomic Research Centre (BARC), India, Malabar Cancer Care Society Kannur, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of non-radiologist portable ultrasound device for triaging women with positive clinical breast examination	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.	Through study completion, an average of 1 year
Secondary	Agreement between portable ultrasound device and mammography/ultrasound	Agreement between portable ultrasound device and mammography/ultrasound by a radiologist in differentiating malignant and benign solid breast lesions.	Through study completion, an average of 1 year