Identification of Breast Cancer in Breath Samples Using Trained Detection Dogs

NCT07038785 | Recruiting

• 2 other identifiers: P-0001Pro2024-0383
• Study Type: observational
• Target: 1,204
• Locations: 2 countries
• Sites: 5

Brief 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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Screening; Breath Samples; Cancer Detection

Outcome Measures

Primary Outcomes (1)

• Test Performance Evaluation

  The test performance will be determined by analysis of the sensitivity and the specificity of the primary endpoint sample set, where sensitivity is the number of participants with a true positive result divided by the number of participants with a positive clinical diagnosis (positive biopsy), and specificity is the number of participants with a true negative result divided by the number of participants with a negative clinical diagnosis.

  24 months

Secondary Outcomes (4)

• Test Performance Evaluation in different subgroups

  24 months

• Test Performance in early-stage cancer

  24 months

• Test Performance in the clinic vs. at patients' home

  24 months

• Effect of psychological impacts on performance in the enriched arm

  12 months

Study Arms (2)

Target Population Arm

Women scheduled for routine breast cancer screening by mammography/ultrasound/magnetic resonance imaging

Diagnostic Test: Breath test

Enriched Arm

Women scheduled for breast biopsy with a Breast Imaging and Reporting Data System (BI-RADS®) score of 4B or above

Diagnostic Test: Breath test

Interventions

Breath test DIAGNOSTIC_TEST

Breath sample collection using a sample collection kit

Enriched Arm; Target Population Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All eligible subjects who are seen at the medical center/study site for their breast cancer screening and biopsy.

You may qualify if:

• 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.
• Assigned female at birth.
• years of age and above OR
• 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
• 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.
• Scheduled for routine annual breast cancer screening (Mammogram, Ultrasound and MRI)
• Capable of giving informed consent for self, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
• Assigned female at birth.
• years of age and above. OR
• 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
• 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.
• BI-RADS® score of 4B.
• Scheduled for breast biopsy.

You may not qualify if:

• Had cancer within the past year. Individuals who underwent surgical removal of cancerous non-metastatic skin lesions can be recruited.
• Has received any cancer treatments within the past year.
• Has participated in another clinical study in the past 30 days.
• Had bilateral mastectomy for breast cancer or for preventive reasons related to breast cancer.
• 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.

Sponsors & Collaborators

• SpotitEarly: lead
• Hackensack Meridian Health: collaborator

Study Sites (5)

Hackensack Meridian Health

Totowa, New Jersey, 07512, 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

Biospecimen

Retention: SAMPLES WITHOUT DNA

Exhaled breath samples

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Breath Tests

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Udi Bobrovsky

CONTACT

+972-54-456-0008; udi@spotitearly.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 26, 2025
• Study Start: July 22, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); IL (4)