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NCT01766102 · ClinicalTrials.gov registry record · Phase 4
Intra-operative Digital vs. Standard Mammography
A Phase 4 study of Breast Cancer, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 72
- Enrollment target
- 1
- Study location
NCT01766102: Completed Phase 4 study of Breast Cancer, sponsored by Massachusetts General Hospital.
NCT01766102 is a Phase 4 study of Breast Cancer that has completed, run by Massachusetts General Hospital. The registered enrollment target is 72 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01766102, a Phase 4 study of Breast Cancer, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 72 participants
- Enrollment target
- 1
- Study location
Study Summary
A breast biopsy in the operating room may be needed in up to 15% of patients with an abnormality on mammogram. When an abnormality is present but there is no palpable mass, the abnormality must be localized with a wire before going to the operating room. This technique is also used when a breast cancer is present but there is no mass, in order to perform a targeted lumpectomy. Once the abnormality is surgically removed, the specimen with the wire is taken to the breast imaging department for a specimen x-ray to ensure that the targeted abnormality is present within the specimen. If the abnormality is close to the edge of the specimen, additional tissue is often removed. A newer method for evaluating the specimen is to perform imaging in the operating room. Portable digital mammography units are available for this purpose. The Biovision digital specimen mammography system is FDA-approved and currently in use in over 200 centers in the United States. Several studies have shown that intra-operative digital mammography is as accurate as standard specimen mammography and takes less time to perform. It may also decrease the chance of having to go back to the operating room to take more breast tissue after lumpectomy because of cancer cells near teh margin(s) of the specimen on final pathology. Having to go back to the operating room to take more tissue is called a re-excision. The purpose of this study is to compare standard specimen mammography to intra-operative specimen mammography to quantify potential operating room time savings and to determine if the use of intra-operative specimen mammography decreases re-excision rates. We aim to see if intra-operative specimen mammography is more efficient and if it decreases re-excision rates.
Primary Outcome
To compare the overall operative time savings using intra-operative digital mammography compared with standard specimen mammography.
Conditions Studied
Interventions
- PROCEDURE Intra-operative Mammography
- PROCEDURE Standard Mammography
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2013-01 |
| Est. Completion | 2014-12 |
| Phase | Phase 4 |
What the finished NCT01766102 record still lists
NCT01766102 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Intra-operative Mammography is the first listed.
NCT01766102 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01766102 about?
NCT01766102 is a clinical study titled "Intra-operative Digital vs. Standard Mammography". A breast biopsy in the operating room may be needed in up to 15% of patients with an abnormality on mammogram. When an abnormality is present but there is no palpable mass, the abnormality must be localized with a wire before going to the operating room. This technique is also used when a breast can...
What is the current status of trial NCT01766102?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 72 participants. The study started on 2013-01. Estimated completion is 2014-12.
What conditions does trial NCT01766102 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT01766102?
The interventions under investigation include: Intra-operative Mammography (PROCEDURE), Standard Mammography (PROCEDURE).
Who is sponsoring clinical trial NCT01766102?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01766102 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01766102's enrollment target sits among peer trials
72 685th of 1224 higher than 533 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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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