RightFit
RecruitingPhase not listed

Identification of Breast Cancer in Breath Samples Using Trained Detection Dogs

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Ultrasound, Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether trained dogs and artificial intelligence (AI), a computer system, can find breast cancer in breath samples. It is for women who are scheduled for breast cancer screening or a breast biopsy and meet the study rules. Participants breathe into a surgical mask, and the study compares the breath test results with their screening or biopsy results.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be able to give your own consent and follow the study rules.
  • You must have been assigned female at birth.
  • For either group, you must be 40 or older, or meet one of the younger-age rules below.
  • For either group, you may qualify at ages 18–39 if you have an inherited gene change linked to high breast cancer risk in BRCA1, BRCA2, PTEN, TP53, CDH1, STK11, ATM, CHEK2, BARD1, RAD51D, RAD51C, or PALB2.
  • For the screening group, you must be scheduled for yearly breast cancer screening, such as a mammogram, ultrasound, or MRI.
  • For the screening group, you may also qualify at ages 18–39 if breast or ovarian cancer was found before age 50 in at least one first-degree relative (parent, sibling, or child) or two second-degree relatives (such as grandparents, aunts, or uncles).
  • For the biopsy group, you must have a BI-RADS score of 4B, a breast scan rating showing possible cancer, and be scheduled for a biopsy (removing tissue to test for cancer).
  • For the biopsy group, you may also qualify at ages 18–30 if breast or ovarian cancer was found before age 35 in at least one first-degree relative (parent, sibling, or child) or two second-degree relatives (such as grandparents, aunts, or uncles).

Who can't join

  • You had cancer in the past year. You may still qualify if skin cancer that had not spread was removed by surgery.
  • You received any cancer treatment in the past year.
  • You took part in another clinical study in the past 30 days.
  • You had both breasts removed to treat or prevent breast cancer.
  • You had a procedure inside your chest or airways in the past 2 weeks that could keep you from giving a normal breath sample.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (2)

NJ

PA