Study to Validate a Breath Test Using Detection Dogs and AI for Breast Cancer Detection In Women Scheduled for Routine Breast Screening or Biopsy

What this Trial Is About

Researchers are investigating whether a system using trained detection dogs and artificial intelligence AI can identify breast cancer from a persons breath. The study involves women scheduled for routine breast cancer screenings such as mammograms, ultrasounds, or biopsies. The purpose is to compare the detection results from the dogs and AI to the actual medical screening or biopsy results to evaluate the accuracy of this breath test approach. Participants will provide breath samples by breathing into a surgical mask. These samples will be sent to a specialized laboratory where trained detection dogs and an AI system will analyze the breath for signs of breast cancer. The study includes two groups women scheduled for routine screening and women scheduled for breast biopsy with a higher risk score. The study will run for up to 24 months to assess test performance overall and in various subgroups. During the study, participants will provide breath samples and undergo their scheduled breast cancer screenings or biopsies. Researchers will evaluate the accuracy of the breath test compared to clinical results. Secondary analyses will look at performance in early-stage cancer and the impact of psychological factors. Participants involvement includes providing samples and attending routine screenings, with the total study duration extending up to two years.

Identification of Breast Cancer in Breath Samples Using Trained Detection Dogs