A Safe and Non-invasive Breast Cancer Screening Solutio

Not Applicable

Completed

• Conditions: Health Condition 1: C509- Malignant neoplasm of breast of unspecified siteHealth Condition 2: R688- Other general symptoms and signsHealth Condition 3: null- possible symptoms of suspected breast cancer

• Registration Number: CTRI/2017/10/010115
• Lead Sponsor: IRAMAI Health Analytix Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-07-31
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 258

Inclusion Criteria

1. Female subjects equal to and above 18 years presenting with the following breast abnormalities:

(1a) Palpable lump, swelling or mass in breast

(1b) Persistent breast pain or tenderness that is unrelated to menstrual cycle

(1c) Nipple is inverted or tender, painful, scaly or with discharge (clear or bloody)

(1d) Skin on breast is dimpled, red, blotchy, pricking, itchy or has change in the texture

(1e) Increase in breast size that is not related to menstrual cycle

(1f) Thickening in or around the breast or underarm area

(1g) Or any other symptoms leading to suspicion of breast cancer

2. Subjects who are willing to give written informed consent for study participation

3. Subjects who are ready to comply with the study related visits and procedures

Exclusion Criteria

1. Subjects who are pregnant

2. Subjects who are lactating

3. Subjects who have undergone either lumpectomy or mastectomy

4. Subjects who have undergone Chemotherapy in the last 2 weeks at the time of study enrollment

5. Any active illness, psychological and/or pathological condition that would interfere with study participation in the opinion of the Investigator

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. non-inferiority of sensitivity of Thermalytix to not more than 10% of the standard screening modalities <br/ ><br>2.Sensitivity <br/ ><br>3. Specificity <br/ ><br>4.PPV <br/ ><br>5.NPVTimepoint: 24 weeks

Secondary Outcome Measures

Name	Time	Method
1. Influence of patient characteristics on diagnostic accuracy of Thermalytix©. <br/ ><br>Patient characteristics will include: <br/ ><br>(a) Age <br/ ><br>(b) Lesion type <br/ ><br>(c) Pathologic diagnosis <br/ ><br>(d) Menopausal and hormonal status <br/ ><br>(e) Breast density <br/ ><br>(f) Family history <br/ ><br>(g) Risk factors <br/ ><br>2. Recommend how Thermalytix© can be used to complement standard breast cancer screening procedure. <br/ ><br>Timepoint: 24 weeks