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| ID | Type | Description | Link |
|---|---|---|---|
| Pro2024-0383 | Other Identifier | Hackensack Meridian Health |
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| Name | Class |
|---|---|
| Hackensack Meridian Health | OTHER |
| University of Pennsylvania | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Target Population Arm | Women scheduled for routine breast cancer screening by mammography/ultrasound/magnetic resonance imaging |
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| Enriched Arm | Women scheduled for breast biopsy with a Breast Imaging and Reporting Data System (BI-RADS®) score of 4B or above |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breath test | Diagnostic Test | Breath sample collection using a sample collection kit |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Test Performance Evaluation in different subgroups | Sensitivity and specificity of the SpotitEarly test will be measured and compared in each of the subgroups:
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INCLUSION CRITERIA FOR ARM 1 (TARGET POPULATION ARM)
INCLUSION CRITERIA FOR ARM 2 (ENRICHED ARM)
EXCLUSION CRITERIA (BOTH STUDY ARMS)
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All eligible subjects who are seen at the medical center/study site for their breast cancer screening and biopsy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Udi Bobrovsky | Contact | +972-54-456-0008 | udi@spotitearly.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hackensack Meridian Health | Recruiting | Totowa | New Jersey | 07512 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D001944 | Breath Tests |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Exhaled breath samples
| 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. | 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. | 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. | 12 months |
| Hospital of the University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Rambam Health Care Campus | Recruiting | Haifa | Israel |
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| Sheba Medical Center | Recruiting | Ramat Gan | Israel |
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| Assuta Medical Centers | Recruiting | Tel Aviv | Israel |
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| Tel Aviv Sourasky Medical Center | Recruiting | Tel Aviv | Israel |
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| D017437 |
| Skin and Connective Tissue Diseases |