Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-26 @ 1:55 AM
Study NCT ID:
NCT07266194
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-05
First Post:
2025-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Study Will Enroll Females Who Are Coming in for Their Annual Mammogram Screening and Who Are Schedule for a Biopsy to Provide a Breath Sample Via a Mask to Evaluate if Breast Cancer Can be Detected.
Sponsor:
Abramson Cancer Center at Penn Medicine
Organization:
Study Overview
Official Title:
A Double-Blind Observational Study to Validate the SpotitEarly Test for the Detection of Breast Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objective:
1\. To evaluate the sensitivity of the SpotitEarly test for breast cancer detection in women
Secondary Objectives:
1. To evaluate the performance of the SpotitEarly in various subgroups.
2. To evaluate the performance of the SpotitEarly test in detecting early-stage cancer (stages 0-2).
3. To assess whether the performance of the SpotitEarly test is affected by psychological impacts (e.g. anxiety) related to the biopsy procedure.
Exploratory Objective:
1\. To evaluate the test-retest reliability of SpotitEarly's test.
1\. To evaluate the sensitivity of the SpotitEarly test for breast cancer detection in women
Secondary Objectives:
1. To evaluate the performance of the SpotitEarly in various subgroups.
2. To evaluate the performance of the SpotitEarly test in detecting early-stage cancer (stages 0-2).
3. To assess whether the performance of the SpotitEarly test is affected by psychological impacts (e.g. anxiety) related to the biopsy procedure.
Exploratory Objective:
1\. To evaluate the test-retest reliability of SpotitEarly's test.
Detailed Description:
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 screening breast cancer screening, 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: