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NCT05046301 · ClinicalTrials.gov registry record
Contrast-Enhanced Mammography for the Evaluation of Mammographic Microcalcifications
A clinical trial of Breast Carcinoma, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- 59
- Enrollment target
- 1
- Study location
NCT05046301: Active study of Breast Carcinoma, sponsored by M.D. Anderson Cancer Center.
NCT05046301 is a study of Breast Carcinoma that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 59 participants, below the 770-participant average among 106 other Breast Carcinoma trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05046301, a study of Breast Carcinoma, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- 59 participants
- Enrollment target
- 1
- Study location
Study Summary
This clinical trial evaluates the added role of contrast-enhanced mammography (CEM), as well as imaging and blood biomarkers, for predicting the presence or absence of high-grade ductal carcinoma in situ (DCIS) or invasive cancer on pathology. Screening mammography is the mainstay of population-wide early breast cancer detection, and mammography-detected cancers are usually of an earlier stage, giving women the best chance of survival. However, the main drawbacks of this type of screening are false positive results and potential over-diagnosis of breast cancer. Suspicious microcalcifications detected with mammography pose a particular diagnostic problem, as they may be associated with invasive and high-grade in-situ cancers like DCIS, but are more often benign or require further workup to verify diagnosis. As such, microcalcifications detected by mammography pose a risk of both over-diagnosis and underestimation of disease severity. This study evaluates the impact of using CEM, compared to standard full field digital mammography (FFDM) for the management of suspicious microcalcifications and prediction of breast cancer in women with this finding.
Primary Outcome
Determined by comparing the contrast-enhanced mammography (CEM)/full field digital mammography (FFDM) results to those of the pathologic evaluations. Specifically, it is defined as the number of concordant cases between CEM/FFDM and pathologic evaluation divided by the total sample size. Descriptive statistics will be used to summarize clinical variables of interest. Specifically, categorical measures will be summarized using frequencies and percentages, and continuous measures will be summarize
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- OTHER Questionnaire Administration
- OTHER Contrast Agent
- PROCEDURE Contrast-Enhanced Mammography
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2021-03-23 |
| Est. Completion | 2027-02-02 |
What the registry record for NCT05046301 still lists
NCT05046301 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 770-participant average among 106 other Breast Carcinoma trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Breast Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Biospecimen Collection is the first listed.
NCT05046301 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT05046301 about?
NCT05046301 is a clinical study titled "Contrast-Enhanced Mammography for the Evaluation of Mammographic Microcalcifications". This clinical trial evaluates the added role of contrast-enhanced mammography (CEM), as well as imaging and blood biomarkers, for predicting the presence or absence of high-grade ductal carcinoma in situ (DCIS) or invasive cancer on pathology. Screening mammography is the mainstay of population-wide...
What is the current status of trial NCT05046301?
This trial is currently active not recruiting. The enrollment target is 59 participants. The study started on 2021-03-23. Estimated completion is 2027-02-02.
What conditions does trial NCT05046301 study?
This clinical trial studies the following conditions: Breast Carcinoma.
What interventions are being tested in trial NCT05046301?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Questionnaire Administration (OTHER), Contrast Agent (OTHER), Contrast-Enhanced Mammography (PROCEDURE).
Who is sponsoring clinical trial NCT05046301?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05046301 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05046301's enrollment target sits among peer trials
59 74th of 106 higher than 33 of 106 other Breast Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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