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.

NCT07266194 | Not Yet Recruiting

• 1 other identifier: 859242
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

Primary Objective: 1\. To evaluate the sensitivity of the SpotitEarly test for breast cancer detection in women Secondary Objectives:

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

Conditions

Breast Cancer Detection

Keywords

Breast cancer; Screening; Breath Samples; Cancer Detection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Sensitivity of the SpotitEarly test in detecting early-stage cancer among breast cancer-positive samples

  24 months

Study Arms (2)

Target Population Arm

Women scheduled for routine breast cancer screening.

Other: Breathing Mask

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

Interventions

Breathing Mask OTHER

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: Probability Sample

Study Population

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• SpotitEarly: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

Exhaled breath samples

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Brian S Englander, MD

  Penn Medicine

  PRINCIPAL INVESTIGATOR

• Brian S. Englander, MD

  Penn Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Autumn Winch, BS

CONTACT

445-273-2715; Autumn.Winch@pennmedicine.upenn.edu

Namaijah Faison, MS

CONTACT

215-829-2224; Namaijah.Faison@pennmedicine.upenn.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Department of Radiology at Pennsylvania Hospital

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 5, 2025
• Study Start: December 10, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 5, 2025

Record last verified: 2025-12