Identification of Breast Cancer in Breath Samples Using Trained Detection Dogs

Launched by SPOTITEARLY · Jun 23, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to detect breast cancer by using trained dogs and artificial intelligence (AI) to analyze a person’s breath. Women who are already scheduled for routine breast cancer screening, like a mammogram, ultrasound, or biopsy, may be invited to participate. To take part, participants will simply breathe into a special surgical mask that collects their breath sample. This mask will then be sent to a lab where the dogs and AI system will “sniff” the sample to look for signs of breast cancer. The results from the dogs and AI will be compared to the participants’ actual medical test results to see how well this method works.

Women eligible for this study include those 40 years and older or younger women who have a higher risk of breast cancer because of their family history or specific genetic factors. Participants should be scheduled for regular breast cancer screening or a biopsy and must be able to give informed consent. Women who have had cancer or cancer treatment in the past year or recent chest procedures will not be eligible. If you join, you’ll provide a simple breath sample using a mask, and then the study team will compare the detection dogs’ and AI’s findings with your usual screening results. This study is still not recruiting participants yet but aims to develop a potentially easier and less invasive way to help detect breast cancer in the future.

Gender

FEMALE

Eligibility criteria

• • INCLUSION CRITERIA FOR ARM 1 (TARGET POPULATION ARM)
• • 1. Capable of giving informed consent for self, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
• • 2. Assigned female at birth.
• • 3. 40 years of age and above OR
• • 4. Between 18 and 39 years of age (inclusive) and a carrier of germline pathogenic variants associated with high risk for breast cancer: BRCA1, BRCA2, PTEN, TP53, CDH1, or STK11 ATM, CHEK2, BARD1, RAD51D, RAD51C, PALB2, OR
• • 5. Between 18 and 39 years of age (inclusive) with a family history of breast or ovarian cancer involving at least one first or two second-degree relatives who were diagnosed with breast or ovarian cancer before the age of 50 years.
• • 6. Scheduled for routine annual breast cancer screening (Mammogram, Ultrasound and MRI)
• • INCLUSION CRITERIA FOR ARM 2 (ENRICHED ARM)
• • 1. Capable of giving informed consent for self, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
• • 2. Assigned female at birth.
• • 3. 40 years of age and above. OR
• • 4. Between 18 and 39 years of age (inclusive) and a carrier of germline pathogenic variants associated with high risk for breast cancer: BRCA1, BRCA2, PTEN, TP53, CDH1, or STK11 ATM, CHEK2, BARD1, RAD51D, RAD51C, PTEN , PALB2 OR
• • 5. Between 18 and 30 years of age (inclusive) with a family history of breast or ovarian cancer involving at least one first or two second-degree relatives who were diagnosed with breast or ovarian cancer before the age of 35 years.
• • 6. BI-RADS® score of 4B.
• • 7. Scheduled for breast biopsy.
• • EXCLUSION CRITERIA (BOTH STUDY ARMS)
• • 1. Had cancer within the past year. Individuals who underwent surgical removal of cancerous non-metastatic skin lesions can be recruited.
• • 2. Has received any cancer treatments within the past year.
• • 3. Has participated in another clinical study in the past 30 days.
• • 4. Had bilateral mastectomy for breast cancer or for preventive reasons related to breast cancer.
• • 5. Had a medical procedure in the chest cavity and/or airways within the past 2 weeks which may interfere with the ability to provide a normal breath sample as required by the protocol.