Breast CancerPINKNCT07038785
Identification of Breast Cancer in Breath Samples Using Trained Detection Dogs
An observational study of Breast Cancer, run by SpotitEarly at 6 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Breath test
- How many people
- 1,204 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 22 Jul 2025to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: All eligible subjects who are seen at the medical center/study site for their breast cancer screening and biopsy.
Who may be able to join
- 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)
Show all 13Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 2 countries
Israel4 sites, 4 recruiting
- Recruiting
Rambam Health Care Campus
Haifa
Elizabeth Half, MD, +972-52-5620345, E_Half@rambam.health.gov.il
Elizabeth Half, MD
- Recruiting
Sheba Medical Center
Ramat Gan
Miri Sklair-Levy, MD, +972-52-6666620, miri.sklairlevy@sheba.health.gov.il
Miri Sklair-Levy, MD
- Recruiting
Assuta Medical Centers
Tel Aviv
Merav Ben-David, MD, +972-52-6667599, meravak@assuta.co.il
Merav Ben-David, MD
- Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv
Shiran Shapira, PhD, +972-3-6974827, shiransha@tlvmc.gov.il
Nadir Arber, MD
United States2 sites, 2 recruiting
- Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Autumn Winch, BS, 445-273-2715, Autumn.Winch@pennmedicine.upenn.edu
Namaijah Faison, 215-829-2224, Namaijah.Faison@pennmedicine.upenn.edu
- Recruiting
Hackensack Meridian Health
Totowa, New Jersey, 07512
Lee Ifhar, MSc, CCRP, 551-215-0508, Lee.ifhar@hmhn.org
Elias Obeid, MD, MPH
About this study
Official title: 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.
- Conditions
- Breast Cancer
- Being tested
- Breath test
- Keywords
- Breast Cancer, Screening, Breath Samples, Cancer Detection
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath testDiagnostic test
Breath sample collection using a sample collection kit
| Study group | Role | What they receive |
|---|---|---|
| Target Population Arm | Women scheduled for routine breast cancer screening by mammography/ultrasound/magnetic resonance imaging Receives: Diagnostic Test: Breath test | |
| Enriched Arm | Women scheduled for breast biopsy with a Breast Imaging and Reporting Data System (BI-RADS®) score of 4B or above Receives: Diagnostic Test: Breath test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start22 Jul 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SpotitEarly
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hackensack Meridian Health, University of Pennsylvania
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07038785
- Sponsor's protocol ID
- P-0001
- Other IDs
- Pro2024-0383
- Acronym
- PINK
- Status last verified
- Aug 2025
- First submitted
- 11 Jun 2025
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Observational Study to Validate the SpotitEarly Test for the Detection of Breast Cancer (The PINK Study)
- ClinicalTrials.gov ID
- NCT07038785
- Acronym / sponsor ID
- PINK / P-0001
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Screening, Breath Samples, Cancer Detection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,204 participants (estimated)
- Lead sponsor
- SpotitEarlyIndustry (pharma, biotech, devices)
- Collaborators
- Hackensack Meridian Health, University of Pennsylvania
- Study start
- 22 Jul 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 26 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Target Population Arm | – | Diagnostic Test: Breath testWomen scheduled for routine breast cancer screening by mammography/ultrasound/magnetic resonance imaging |
| Enriched Arm | – | Diagnostic Test: Breath testWomen scheduled for breast biopsy with a Breast Imaging and Reporting Data System (BI-RADS®) score of 4B or above |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All eligible subjects who are seen at the medical center/study site for their breast cancer screening and biopsy.
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breath testBreath sample collection using a sample collection kit | Diagnostic test | Enriched Arm, Target Population Arm |
Primary outcome
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.
4 secondary outcomes
Test Performance Evaluation in different subgroups
Time frame: 24 months
Test Performance in early-stage cancer
Time frame: 24 months
Test Performance in the clinic vs. at patients' home
Time frame: 24 months
Effect of psychological impacts on performance in the enriched arm
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by SpotitEarly at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Israel, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Udi Bobrovsky (+972-54-456-0008, udi@spotitearly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test Performance Evaluation (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.