Detecting breast cancer from breath using trained dogs and AI

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

This test will see if trained detection dogs and an AI system can find signs of breast cancer from breath samples in people coming for routine breast screening.

Quick facts

• Study type: Observational
• Enrollment: 1204 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: SpotitEarly (Industry-sponsored)
• Locations: 5 sites (Totowa, New Jersey and 4 other locations)
• Trial ID: NCT07038785 on ClinicalTrials.gov

What this trial studies

This observational project collects breath samples on surgical masks from women who are attending routine breast imaging (mammogram, ultrasound, MRI) or a biopsy. Samples are sent to a laboratory and are reviewed both by trained detection dogs and by an AI-based analytic system to look for scent or chemical patterns linked to breast cancer. Findings from the dogs and AI are compared to the participants' imaging or biopsy results to measure how accurately the methods detect cancer. Enrollment includes people assigned female at birth who meet the study's age or genetic/family-history risk criteria at participating centers in the United States and Israel.

Who should consider this trial

Good fit: Ideal candidates are people assigned female at birth who are 40 or older scheduled for routine breast screening, or those aged 18–39 with high-risk genetic variants or a strong family history who are scheduled for screening.

Not a fit: People who are not assigned female at birth, who are not undergoing scheduled breast screening, or who cannot provide a breath sample are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this approach could offer a simple, noninvasive screening tool to help detect breast cancer earlier.

How similar studies have performed: Previous small studies have suggested that detection dogs and breath-based AI can detect certain cancers, but the evidence is preliminary and results have been mixed.

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.

Where this trial is running

Totowa, New Jersey and 4 other locations

• Hackensack Meridian Health — Totowa, New Jersey, United States (Recruiting)
• Rambam Health Care Campus — Haifa, Israel (Recruiting)
• Sheba Medical Center — Ramat Gan, Israel (Recruiting)
• Assuta Medical Centers — Tel Aviv, Israel (Recruiting)
• Tel Aviv Sourasky Medical Center — Tel Aviv, Israel (Recruiting)

Study contacts

• Study coordinator: Udi Bobrovsky

Conditions Breast Cancer; Screening; Breath Samples; Cancer Detection