RecruitingNCT07038785

Identification of Breast Cancer in Breath Samples Using Trained Detection Dogs

A Double Blind Observational Study to Validate the SpotitEarly Test for the Detection of Breast Cancer (The PINK Study)

Sponsor

SpotitEarly

Enrollment

1,204 participants

Start Date

Jul 22, 2025

Study Type

OBSERVATIONAL

Conditions

Breast Cancer

Summary

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 routine breast cancer screening, such as a mammogram, ultrasound, 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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study explores whether specially trained detection dogs can identify breast cancer from breath samples, which could eventually lead to a non-invasive, low-cost screening method for the disease. **You may be eligible if...** - You were assigned female at birth - You are 40 years old or older, OR you are between 30 and 39 with a family history of breast cancer - You are scheduled for a breast biopsy, or you are a healthy volunteer - You are able to provide informed consent **You may NOT be eligible if...** - You have other active cancers that might confuse the results - You are unable to provide a breath sample - You have had recent dental procedures or conditions affecting your breath composition Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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