Clinical trial · Interventional
Improving Diagnosis of Breast Cancer by Using a Combined MRI and Positron Emission Mammography (MRI-PEM) System
NCT02426489CI-TRIAL-00054332MRI-PEMterminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Subcontract PI left institution.
Summary
Brief summary (as posted)
The purpose of the study is to assess whether the addition of positron emission mammography will add diagnostic value to magnetic resonance imaging of the breast, in patients with lesions of the breast that are suspicious enough to warrant biopsy, or which have been confirmed as containing cancer cells.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI + PEM image | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Diagnostic accuracy with MRI alone
- description
- The MRI of the breast lesion will be examined. Measures of performance accuracy will be evaluated, including diagnostic sensitivity (true positives divided by true positives and false negatives), diagnostic specificity (true negatives divided by true negatives and false positives), and diagnostic accuracy, defined as the number of correct assessments divided by the number of all assessments.
- type
- EXPERIMENTAL
- label
- Diagnostic accuracy with MRI + PEM image
- description
- The combined PEM/MRI image will be examined.
- interventionNames
- Device: MRI + PEM image
Primary outcomes (1)
- measure
- Diagnostic accuracy of combination MRI/positron emission mammography (diagnostic accuracy, defined as the number of correct assessments divided by the number of all assessments)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Female over 21 years of age; * with a suspicious lesion found in the breast and recommended for biopsy or have a confirmed diagnosis of cancer; * and in good health (other than having breast lesions); * and can lie still in a prone position for 30 minutes in an MRI scanner. Exclusion Criteria: * Pregnancy; * unwilling to give informed consent; * have implanted prosthetic heart valve, * pacemaker, * neurostimulator, * surgical clips or other metallic implants; * have engaged in occupations or received orthodontic work which may have caused lodging of ferromagnetic materials in the body; * are claustrophobic; * have been allergic to contrast agents; * are diabetic; * or have a history of kidney disease.
References
Publications (0)
Data not yet available
No reference posted for this study.