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.

A Double-Blind Observational Study to Validate the SpotitEarly Test for the Detection of Breast Cancer

Primary Objective:

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

Secondary Objectives:

1. To evaluate the performance of the SpotitEarly in various subgroups.
2. To evaluate the performance of the SpotitEarly test in detecting early-stage cancer (stages 0-2).
3. 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer Detection
• Intervention / Treatment: Other: Breathing Mask

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Autumn Winch, BS; Phone Number: 445-273-2715; Email: Autumn.Winch@pennmedicine.upenn.edu
• Study Contact Backup: Name: Namaijah Faison, MS; Phone Number: 215-829-2224; Email: Namaijah.Faison@pennmedicine.upenn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

All eligible subjects who are seen at Pennsylvania Hospital for their breast cancer screening and biopsy.

Description

Inclusion Criteria for Arm 1 (Target Population Arm)

1. 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.
2. Assign female at birth.
3. Scheduled for routine annual breast cancer screening
4. 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)

1. 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.
2. Assigned female at birth
3. Scheduled for breast biopsy.
4. BI-RADS® screening score of 4B or above
5. 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)

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Enriched Arm; Women scheduled for breast biopsy with a Breast Imaging and Reporting Data System (BI-RADS®) score of 4B or above	Other: Breathing Mask; Breath sample collection using a sample collection kit
Target Population Arm; Women scheduled for routine breast cancer screening.	Other: Breathing Mask; Breath sample collection using a sample collection kit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and specifically of the SpotitEarly testing in each of the subgroups	Age: under 40, 40-49, 50-64, 65 and older. Race: White, Black/African American, Asian and Pacific Islander, Native American/ Alaska Native, more than one race. Germline pathogenic variant carriers associated with high risk for breast cancer (BRCA1, BRCA2, PTEN, TP53, CDH1, STK11) versus non-carriers. Smoking status: smokers versus non-smokers. Women with type-2 diabetes versus women who were not diagnosed with the disease.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of the SpotitEarly test in detecting early-stage cancer among breast cancer-positive samples	he test's specificity and its confidence interval (CI) will be analyzed in the following subgroups: Negative non-benign samples in Arm 1. All benign samples in Arm 1. Benign samples in Arm 1 of participants with a BI-RADS® score of 4B or above. Benign samples in Arm 2.	24 months

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine
• Collaborators: SpotitEarly
• Investigators: Principal Investigator: Brian S Englander, MD, Penn Medicine; Principal Investigator: Brian S. Englander, MD, Penn Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): December 10, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: December 3, 2025
• First Posted (Actual): December 5, 2025

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Breast cancer; Screening; Cancer Detection; Breath Samples
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: 859242

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No