FindTrial
Sign In

A Safe and Non-invasive Breast Cancer Screening Solution

Multicentric Study to evaluate the effectiveness of Thermalytix© (automated thermographic screening algorithms developed by NIRAMAI) as compared to standard screening modalities in subjects who show possible symptoms of suspected breast cancer - SANT17

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2017/10/010115
Enrollment
275
Registered
2017-10-16
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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 Health Condition 2: R688- Other general symptoms and signs Health Condition 3: null- possible symptoms of suspected breast cancer

Interventions

Control Intervention1: Clinical Breast Examination, Sono-Mammography and Mammography: Clinical Breast Examination, Sono-Mammography and Mammography are standard screening modalities for Breast cancer

Sponsors

NIRAMAI Health Analytix Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
1. non-inferiority of sensitivity of Thermalytix to not more than 10% of the standard screening modalities 2.Sensitivity 3. Specificity 4.PPV 5.NPVTimepoint: 24 weeks—

Secondary

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

Countries

India

Contacts

Public ContactGeetha Manjunath

HCG Cancer Hospital

dr_sudhakar79@yahoo.com9008801379

Outcome results

None listed

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