Identification of Breast Cancer in Breath Samples Using Trained Detection Dogs (NCT07038785)
A Double Blind Observational Study to Validate the SpotitEarly Test for the Detection of Breast Cancer (The PINK Study)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Hackensack Meridian Health — Totowa, New Jersey
Age range: 18 Years
🧪 Interventions in This Study
- Breath test (DIAGNOSTIC_TEST)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (6 Sites)
- Hackensack Meridian Health — Totowa, New Jersey
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania
- Rambam Health Care Campus — Haifa,
- Sheba Medical Center — Ramat Gan,
- Assuta Medical Centers — Tel Aviv,
- Tel Aviv Sourasky Medical Center — Tel Aviv,
📞 Contact the Study Coordinator
Phone: +972-54-456-0008
Email: udi@spotitearly.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.