NCT07266194

The Study Will Enroll Females Who Are Coming in for Their Annual Mammogram Screening and Who Are Schedule for a Biopsy to Provide a Breath Sample Via a Mask to Evaluate if Breast Cancer Can be Detected.

A Double-Blind Observational Study to Validate the SpotitEarly Test for the Detection of Breast Cancer

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Primary Objective: 1\. To evaluate the sensitivity of the SpotitEarly test for breast cancer detection in women Secondary Objectives: 1. To evaluate the performance of the SpotitEarly in various subgroups. 2. To evaluate the performance of the SpotitEarly test in detecting early-stage cancer (stages 0-2). 3. To assess whether the performance of the SpotitEarly test is affected by psychological impacts (e.g. anxiety) related to the biopsy procedure. Exploratory Objective: 1\. To evaluate the test-retest reliability of SpotitEarly's test.

Detailed description

The goal of this study is to find out whether a system that uses trained detection dogs and artificial intelligence (AI) can identify breast cancer from a person's breath. Women who are scheduled to have screening breast cancer screening, or a biopsy for a possible cancer, will be invited to take part. Participants will be asked to breathe into a surgical mask to collect a breath sample. The mask will be sent to a special laboratory, where trained dogs and an AI-based system will check the sample for signs of breast cancer. The results from the dogs and AI will be compared to the actual results from the medical screening or biopsy to see how accurate the system is at detecting breast cancer.

Conditions

• Breast Cancer Detection

Interventions

Type	Name	Description
OTHER	Breathing Mask	Breath sample collection using a sample collection kit

Timeline

• Start date: 2025-12-10
• Primary completion: 2026-12-01
• Completion: 2027-01-01
• First posted: 2025-12-05
• Last updated: 2025-12-05