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NCT04257799 · ClinicalTrials.gov registry record
Lumpectomy Specimen Margin Evaluation With Tomography and Structured Light Imaging
A clinical trial, sponsored by Dartmouth-Hitchcock Medical Center.
- Completed
- Registry status
- 100
- Enrollment target
NCT04257799: Completed study, sponsored by Dartmouth-Hitchcock Medical Center.
NCT04257799 is a clinical trial that has completed, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 100 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04257799 has completed, sponsored by Dartmouth-Hitchcock Medical Center.
- COMPLETED
- Registry status
- 100 participants
- Enrollment target
Study Summary
The purpose of this study is to test a new surgical imaging system called "Structured Light Imaging (SLI)." This system is designed to examine tissue removed during breast cancer surgery to see whether the tissue's edges contain cancer. The current standard of practice is to remove the breast tumor tissue and send the tissue to the lab for analysis following surgery. One in five women (in the US) must later return for a second surgery to remove cancer cells that the lab found remaining in the tissue. In this study, researchers hope that the new SLI system may detect the cancer cells in the tissue's edges by imaging at the time of surgery. If successful, in the future we may use this system to improve entire cancer removal at the time of surgery, and reduce the need to perform a second surgery to remove additional breast tissue.
Primary Outcome
Two surfaces (anterior and posterior) will be evaluated by SLI and 6 surfaces (anterior, posterior, medial, lateral, cranial, and caudal) will be evaluated by 3D tomography. Four surfaces are evaluated by standard-of-care 2-dimensional specimen mammography: medial, lateral, cranial and caudal to evaluate for the presence of cancer at the margin. Since anterior and posterior surfaces will be evaluated by both 3D tomography and SLI, an anterior or posterior margin will be considered positive only
Interventions
- OTHER Structured Light Imaging (SLI) System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2020-02-06 |
| Est. Completion | 2022-03-16 |
What the finished NCT04257799 record still lists
NCT04257799 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Structured Light Imaging (SLI) System is the first listed.
NCT04257799 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04257799 about?
NCT04257799 is a clinical study titled "Lumpectomy Specimen Margin Evaluation With Tomography and Structured Light Imaging". The purpose of this study is to test a new surgical imaging system called "Structured Light Imaging (SLI)." This system is designed to examine tissue removed during breast cancer surgery to see whether the tissue's edges contain cancer. The current standard of practice is to remove the breast tumor ...
What is the current status of trial NCT04257799?
This trial is currently completed. The enrollment target is 100 participants. The study started on 2020-02-06. Estimated completion is 2022-03-16.
What interventions are being tested in trial NCT04257799?
The interventions under investigation include: Structured Light Imaging (SLI) System (OTHER).
Who is sponsoring clinical trial NCT04257799?
This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.
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