The Study Will Enroll Females Who Are Coming in for Their Annual Mammogram Screening and Who Are Schedule for a Biopsy to Provide a Breath Sample Via a Mask to Evaluate if Breast Cancer Can be Detected.

Abramson Cancer Center at Penn Medicine

Status

Not yet enrolling

Conditions

Breast Cancer Detection

Treatments

Other: Breathing Mask

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT07266194

859242

Details and patient eligibility

About

Primary Objective:

1. To evaluate the sensitivity of the SpotitEarly test for breast cancer detection in women

Secondary Objectives:

To evaluate the performance of the SpotitEarly in various subgroups.
To evaluate the performance of the SpotitEarly test in detecting early-stage cancer (stages 0-2).
To assess whether the performance of the SpotitEarly test is affected by psychological impacts (e.g. anxiety) related to the biopsy procedure.

Exploratory Objective:

1. To evaluate the test-retest reliability of SpotitEarly's test.

Full description

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 screening breast cancer screening, 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.

Enrollment

500 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Arm 1 (Target Population Arm)

40 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 of breast cancer: BRCA1, BRCA 2, PTEN, TP53, CDH1 or STK11 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.
Assign female at birth.
Scheduled for routine annual breast cancer screening
Capable of giving consent for self, which includes compliance with the requirements and restriction listed in the Informed Consent and in the protocol.

Inclusion Criteria for Arm 2 (Enriched Arm)

40 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 of breast cancer: BRCA1, BRCA 2, PTEN, TP53, CDH1 or STK11 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.
Assigned female at birth
Scheduled for breast biopsy.
BI-RADS® screening score of 4B or above
Capable of giving consent for self, which includes compliance with the requirements and restriction listed in the Informed Consent and in the protocol.

Exclusion Criteria (Both Arms)

Diagnosis with 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 within the last 30 days.
Had bilateral surgery 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.