A Double Blind Observational Study to Validate the SpotitEarly Test for the Detection of Breast Cancer (The PINK Study)
Trial ID: NCT07038785
Status: RECRUITING
Study type: OBSERVATIONAL
Start date: 2025-07-22
Completion date: 2027-06
Sponsor: SpotitEarly
Collaborators: Hackensack Meridian Health; University of Pennsylvania
Conditions: Breast Cancer
Interventions: Breath test
Locations: Hackensack Meridian Health; Hospital of the University of Pennsylvania; Rambam Health Care Campus; Sheba Medical Center; Assuta Medical Centers; Tel Aviv Sourasky Medical Center
Countries: United States; United States; Israel; Israel; Israel; Israel
Enrollment: 1204
Age range: 18 Years - None
Sex: FEMALE

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 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.

Eligibility criteria:
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.

Outcomes:
Test Performance Evaluation