Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07038785

Identification of Breast Cancer in Breath Samples Using Trained Detection Dogs

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Rambam Health Care Campus, Haifa, Israel

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

FOR ARM 1 (TARGET POPULATION ARM)

  • 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.
  • Assigned female at birth.
  • 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 for breast cancer: BRCA1, BRCA2, PTEN, TP53, CDH1, or STK11 ATM, CHEK2, BARD1, RAD51D, RAD51C, PALB2, 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.
  • Scheduled for routine annual breast cancer screening (Mammogram, Ultrasound and MRI)

Inclusion criteria

FOR ARM 2 (ENRICHED ARM)

  • Capable of giving informed consent for self, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
  • Assigned female at birth.
  • 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 for breast cancer: BRCA1, BRCA2, PTEN, TP53, CDH1, or STK11 ATM, CHEK2, BARD1, RAD51D, RAD51C, PTEN , PALB2 OR
  • 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.
  • BI-RADS® score of 4B.
  • Scheduled for breast biopsy.

Exclusion criteria

(BOTH STUDY ARMS)

  • Had 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 in the past 30 days.
  • Had bilateral mastectomy 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.

Treatment and study plan

Breath test

Diagnostic Test

Breath sample collection using a sample collection kit

Primary outcomes

  1. Test Performance Evaluation

    Time frame: 24 months

    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.

Secondary outcomes

  1. Test Performance Evaluation in different subgroups

    Time frame: 24 months

    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.

  2. Test Performance in early-stage cancer

    Time frame: 24 months

    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.

  3. Test Performance in the clinic vs. at patients' home

    Time frame: 24 months

    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.

  4. Effect of psychological impacts on performance in the enriched arm

    Time frame: 12 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Udi Bobrovsky

CONTACT

[email protected]

+972-54-456-0008

Sponsors and collaborators

Lead sponsor

SpotitEarly

Industry

Collaborators

  • Hackensack Meridian Health
  • University of Pennsylvania

Registry information

Official study title

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

Acronym: PINK

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 26, 2025
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.