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NCT05545150 · ClinicalTrials.gov registry record · Phase 2
Volumetric Specimen Imager Device for the Intraoperative Imaging of Patients With Breast Carcinoma and Breast Ductal Carcinoma In Situ, The VIVID Study
A Phase 2 study of Invasive Breast Carcinoma and Breast Ductal Carcinoma In Situ, sponsored by Northwestern University.
- Active
- Registry status
- Phase 2
- Development phase
- 113
- Enrollment target
- 4
- Study locations
NCT05545150: Active Phase 2 study of Invasive Breast Carcinoma and Breast Ductal Carcinoma In Situ, sponsored by Northwestern University.
NCT05545150 is a Phase 2 study of Invasive Breast Carcinoma and Breast Ductal Carcinoma In Situ that is active but no longer recruiting, run by Northwestern University. The registered enrollment target is 113 participants, below the 483-participant average among 45 other Invasive Breast Carcinoma trials with a reported enrollment target (77% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05545150, a Phase 2 study of Invasive Breast Carcinoma and Breast Ductal Carcinoma In Situ, is active but no longer recruiting, sponsored by Northwestern University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 113 participants
- Enrollment target
- 4
- Study locations
Study Summary
This clinical trial assesses if the use of a three-dimensional imaging device called the Clarix Imaging Volumetric Specimen Imager (VSI) can help guide and assist surgeons in identifying and removing all positive margins while in the operating room (intraoperative imaging) for patients with breast cancer and breast ductal carcinoma in situ. Breast conservation surgery or lumpectomy is a standard of care (routine) procedure that removes the tumor and a rim of surrounding normal tissue (margins) while leaving as much normal breast tissue as possible. A margin that does not contain tumor cells is called a negative margin and tells the surgeon that the primary tumor has been removed. A positive margin contains tumor cells at or near the edge of the tissue removed. As part of standard of care, surgeons take two-dimensional x-ray images of the tissue that has been removed in the operating room to assess if there is any additional tissue that should be shaved (removed) to get a negative margin. After the surgery is over, the tissue is examined once again by a pathologist in a laboratory to determine if there are any small pieces of tumor left in the margin that were not visible during surgery. If residual tumor is detected in the margin, a reoperation may be required to remove additional tissue until the tumor has been completely removed from the margin. Diagnostic procedures, such as intraoperative volumetric specimen imaging may reduce the rate of reoperation of for patients who previously underwent lumpectomy.
Primary Outcome
The primary endpoint of main specimen positive margins identified by volumetric specimen imager (VSI) interpretation and excised intraoperatively is defined as the percentage of patients with at least one main specimen positive margin that was not excised intraoperatively by a VSI-directed shave. A positive margin is defined as ink on tumor (1 or more tumor cells touching the edge of the lumpectomy specimen) for invasive breast cancer and for invasive breast cancer with a ductal carcinoma in sit
Conditions Studied
Interventions
- PROCEDURE Intraoperative Imaging
- DEVICE Lumpectomy
Study Locations (4)
Illinois
- Northwestern University - Chicago
Kentucky
- The University of Kentucky - Lexington
Missouri
- Washington University in St. Louis - St Louis
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2022-11-28 |
| Est. Completion | 2026-07-01 |
| Phase | Phase 2 |
What the registry record for NCT05545150 still lists
NCT05545150 is an interventional study that assigns participants to a tested intervention. The registered 113 participants enrollment target is mid-sized for trials with a published cap, below the 483-participant average among 45 other Invasive Breast Carcinoma trials with a reported enrollment target (77% lower).
The record links to 6 conditions, with Invasive Breast Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Intraoperative Imaging is the first listed.
NCT05545150 reports a single indexed study location in Illinois, Kentucky, Missouri.
Frequently Asked Questions
What is clinical trial NCT05545150 about?
NCT05545150 is a clinical study titled "Volumetric Specimen Imager Device for the Intraoperative Imaging of Patients With Breast Carcinoma and Breast Ductal Carcinoma In Situ, The VIVID Study". This clinical trial assesses if the use of a three-dimensional imaging device called the Clarix Imaging Volumetric Specimen Imager (VSI) can help guide and assist surgeons in identifying and removing all positive margins while in the operating room (intraoperative imaging) for patients with breast c...
What is the current status of trial NCT05545150?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 113 participants. The study started on 2022-11-28. Estimated completion is 2026-07-01.
What conditions does trial NCT05545150 study?
This clinical trial studies the following conditions: Invasive Breast Carcinoma, Breast Ductal Carcinoma In Situ, Anatomic Stage 0 Breast Cancer AJCC v8, Bilateral Breast Carcinoma, Prognostic Stage 0 Breast Cancer AJCC v8.
What interventions are being tested in trial NCT05545150?
The interventions under investigation include: Intraoperative Imaging (PROCEDURE), Lumpectomy (DEVICE).
Who is sponsoring clinical trial NCT05545150?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05545150 being conducted?
This trial has 4 study locations across Illinois, Kentucky, Missouri, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Invasive Breast Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05545150's enrollment target sits among peer trials
113 26th of 45 higher than 20 of 45 other Invasive Breast Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Invasive Breast Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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