Identification of Breast Cancer in Breath Samples Using Trained Detection Dogs

Part of paid clinical trials in Totowa, New Jersey.

Sponsor
SpotitEarly
Study ID
NCT07038785
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Breath test — DIAGNOSTIC_TEST
    Breath sample collection using a sample collection kit

Study Details

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.

Key Dates

Start date
Jul 22, 2025
Status verified
Aug 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
1,204 participants (estimated)

Arms

  • Arm: Target Population Arm
    Women scheduled for routine breast cancer screening by mammography/ultrasound/magnetic resonance imaging
  • Arm: Enriched Arm
    Women scheduled for breast biopsy with a Breast Imaging and Reporting Data System (BI-RADS®) score of 4B or above

Primary Outcome Measure

Test Performance Evaluation [ Time Frame: 24 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Hackensack Meridian HealthTotowaNew Jersey07512
Lee Ifhar, MSc, CCRP
[email protected]
551-215-0508
Elias Obeid, MD, MPH (PRINCIPAL_INVESTIGATOR)
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104
Autumn Winch, BS
[email protected]
445-273-2715
Namaijah Faison
[email protected]
215-829-2224
Brian S Englander, MD (PRINCIPAL_INVESTIGATOR)
Elizabeth McDonald, MD, PhD (SUB_INVESTIGATOR)

Find similar trials in Totowa, NJ

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Hackensack Meridian Health· Totowa, NJHospital of the University of Pennsylvania· Philadelphia, PA

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