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NCT01086514 · ClinicalTrials.gov registry record · NA
Digital Mammography for the Detection and Preoperative Staging of Breast Cancer
A NA study, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- NA
- Development phase
- 82
- Enrollment target
NCT01086514: Completed NA study, sponsored by Memorial Sloan Kettering Cancer Center.
NCT01086514 is a NA study that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 82 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01086514, a NA study, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 82 participants
- Enrollment target
Study Summary
Breast tumors are normally seen with mammography or ultrasound without the use of a dye but the size and extent of the tumor may be hard to see. Currently, after initial mammography, many patients undergo bilateral breast MR to further stage the local tumor. It is able to not only detect anatomic abnormalities but can also evaluate changes such as the development of new blood vessels, which occurs with the development of cancers. MRI is extremely sensitive and detects unsuspected disease in up to 25% of patients, which affects their treatment. It also detects unsuspected cancer in the other breast in some patients. However, MRI is expensive, not always available, and some patients are unable to undergo MRI due to the presence of pacemakers, clips, or claustrophobia. Dual Energy Contrast Enhanced Digital Mammography (DE CEDM) is an investigational procedure that uses a non-standard contrast in a regular digital mammography exam that has been changed to give the needed dual energy and image. DE CEDM is not FDA approved. It is our hope that DE CEDM will also be able to detect unknown tumors because it will also detect new blood vessels. It is less expensive than MRI, could be more available to patients, and can be done on patients with pacemakers and clips. Claustrophobia will not be a problem. We plan to see if (DE CEDM) will help us better see the breast tumor and size of the breast tumor. We will also want to see if DE CEDM can detect additional unsuspected disease in the breast with the known tumor and in the other breast without a known tumor.
Primary Outcome
Every attempt will be made to perform all imaging exams All examinations will be completed within 30 days of scheduled surgery
Interventions
- PROCEDURE Dual Energy Contrast Enhanced Digital Mammography (DE CEDM)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2010-03 |
| Est. Completion | 2012-10 |
| Phase | NA |
What the finished NCT01086514 record still lists
NCT01086514 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Dual Energy Contrast Enhanced Digital Mammography (DE CEDM) is the first listed.
NCT01086514 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01086514 about?
NCT01086514 is a clinical study titled "Digital Mammography for the Detection and Preoperative Staging of Breast Cancer". Breast tumors are normally seen with mammography or ultrasound without the use of a dye but the size and extent of the tumor may be hard to see. Currently, after initial mammography, many patients undergo bilateral breast MR to further stage the local tumor. It is able to not only detect anatomic ab...
What is the current status of trial NCT01086514?
This trial is currently completed. It is a NA study. The enrollment target is 82 participants. The study started on 2010-03. Estimated completion is 2012-10.
What interventions are being tested in trial NCT01086514?
The interventions under investigation include: Dual Energy Contrast Enhanced Digital Mammography (DE CEDM) (PROCEDURE).
Who is sponsoring clinical trial NCT01086514?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01086514's enrollment target sits among peer trials
82 990th of 2000 higher than 1,009 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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