Actively Recruiting

Age: 18Years +
FEMALE
Healthy Volunteers
NCT07038785

Identification of Breast Cancer in Breath Samples Using Trained Detection Dogs

Led by SpotitEarly · Updated on 2025-08-15

1204

Participants Needed

5

Research Sites

97 weeks

Total Duration

On this page

Sponsors

S

SpotitEarly

Lead Sponsor

H

Hackensack Meridian Health

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Identification of Breast Cancer in Breath Samples Using Trained Detection Dogs

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

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.
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 5 locations

1

Hackensack Meridian Health

Totowa, New Jersey, United States, 07512

Actively Recruiting

2

Rambam Health Care Campus

Haifa, Israel

Actively Recruiting

3

Sheba Medical Center

Ramat Gan, Israel

Actively Recruiting

4

Assuta Medical Centers

Tel Aviv, Israel

Actively Recruiting

5

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Actively Recruiting

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Research Team

U

Udi Bobrovsky

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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