Identification of Breast Cancer in Breath Samples Using Trained Detection Dogs (PINK)

A Double Blind Observational Study to Validate the SpotitEarly Test for the Detection of Breast Cancer (The PINK Study)

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Diagnostic test: Breath test

• Study Type: Observational
• Enrollment (Estimated): 1204

Contacts and Locations

• Study Contact: Name: Udi Bobrovsky; Phone Number: +972-54-456-0008; Email: udi@spotitearly.com

Study Locations

• Israel
  • Haifa, Israel
    • Recruiting
    • Rambam Health Care Campus
    • Contact: Elizabeth Half, MD; Phone Number: +972-52-5620345; Email: E_Half@rambam.health.gov.il
    • Principal Investigator: Elizabeth Half, MD
  • Ramat Gan, Israel
    • Recruiting
    • Sheba Medical Center
    • Principal Investigator: Miri Sklair-Levy, MD
    • Contact: Miri Sklair-Levy, MD; Phone Number: +972-52-6666620; Email: miri.sklairlevy@sheba.health.gov.il
  • Tel Aviv, Israel
    • Recruiting
    • Tel Aviv Sourasky Medical Center
    • Contact: Shiran Shapira, PhD; Phone Number: +972-3-6974827; Email: shiransha@tlvmc.gov.il
    • Principal Investigator: Nadir Arber, MD
  • Tel Aviv, Israel
    • Recruiting
    • Assuta Medical Centers
    • Contact: Merav Ben-David, MD; Phone Number: +972-52-6667599; Email: meravak@assuta.co.il
    • Principal Investigator: Merav Ben-David, MD
• United States
  • New Jersey
    • Totowa, New Jersey, United States, 07512
      • Recruiting
      • Hackensack Meridian Health
      • Contact: Lee Ifhar, MSc, CCRP; Phone Number: 551-215-0508; Email: Lee.ifhar@hmhn.org
      • Principal Investigator: Elias Obeid, MD, MPH
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Hospital of the University of Pennsylvania
      • Sub-Investigator: Elizabeth McDonald, MD, PhD
      • Contact: Autumn Winch, BS; Phone Number: 445-273-2715; Email: Autumn.Winch@pennmedicine.upenn.edu
      • Contact: Namaijah Faison; Phone Number: 215-829-2224; Email: Namaijah.Faison@pennmedicine.upenn.edu
      • Principal Investigator: Brian S Englander, MD

Participation Criteria

Eligibility Criteria

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

• 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.

Description

INCLUSION CRITERIA FOR ARM 1 (TARGET POPULATION ARM)

1. 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.
2. Assigned female at birth.
3. 40 years of age and above OR
4. 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
5. 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.
6. Scheduled for routine annual breast cancer screening (Mammogram, Ultrasound and MRI)

INCLUSION CRITERIA FOR ARM 2 (ENRICHED ARM)

1. Capable of giving informed consent for self, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
2. Assigned female at birth.
3. 40 years of age and above. OR
4. 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
5. 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.
6. BI-RADS® score of 4B.
7. Scheduled for breast biopsy.

EXCLUSION CRITERIA (BOTH STUDY ARMS)

1. Had 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 in the past 30 days.
4. Had bilateral mastectomy 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
Target Population Arm; Women scheduled for routine breast cancer screening by mammography/ultrasound/magnetic resonance imaging	Diagnostic test: Breath test; Breath sample collection using a sample collection kit
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; Breath sample collection using a sample collection kit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Test Performance Evaluation in different subgroups	Sensitivity and specificity of the SpotitEarly test will be measured and compared in each of the subgroups: Age: under 40, 40-49, 50-64, 65 and older.; Race: White, Black/African American, Asian.; Ethnicity: hispanic vs. non hispanic; Germline pathogenic variant carriers associated with high risk for breast cancer versus non carriers.; Smoking status: smokers versus nonsmokers.; Women with type-2 diabetes versus not diagnosed with type-2 diabetes Sensitivity is the number of participants with a true positive result divided by the number of participants with a positive clinical diagnosis (positive biopsy). Specificity is the number of participants with a true negative result divided by the number of participants with a negative clinical diagnosis.	24 months
Test Performance in early-stage cancer	To evaluate the performance (sensitivity and specificity) of the SpotitEarly test in detecting early-stage breast cancer (stages 0-2). Sensitivity is the number of participants with a true positive result divided by the number of participants with a positive clinical diagnosis (positive biopsy). Specificity is the number of participants with a true negative result divided by the number of participants with a negative clinical diagnosis.	24 months
Test Performance in the clinic vs. at patients' home	To evaluate the performance (sensitivity and specificity, as described in 3.4) of the SpotitEarly test over samples provided by participants at their home. Sensitivity is the number of participants with a true positive result divided by the number of participants with a positive clinical diagnosis (positive biopsy). Specificity is the number of participants with a true negative result divided by the number of participants with a negative clinical diagnosis.	24 months
Effect of psychological impacts on performance in the enriched arm	To assess whether the performance (sensitivity and specificity) of the SpotitEarly test is affected by the subject's psychological impacts (anxiety is assumed for all arm 2 subjects who are undergoing a biopsy). Sensitivity is the number of participants with a true positive result divided by the number of participants with a positive clinical diagnosis (positive biopsy). Specificity is the number of participants with a true negative result divided by the number of participants with a negative clinical diagnosis.	12 months

Collaborators and Investigators

• Sponsor: SpotitEarly
• Collaborators: University of Pennsylvania; Hackensack Meridian Health

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: June 11, 2025
• First Submitted That Met QC Criteria: June 23, 2025
• First Posted (Actual): June 26, 2025

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: August 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; Diagnostic Techniques and Procedures; Diagnosis; Breath Tests
• Other Study ID Numbers: P-0001; Pro2024-0383 (Other Identifier: Hackensack Meridian Health)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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