Clinical trial · Interventional
Comparison of Positron Emission Mammography and Contrast-enhanced Breast MRI
Comparison of Positron Emission Mammography and Contrast-enhanced Breast MRI in Women With a High Suspicion of Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The hypothesis of this study is that positron emission mammography will provide comparable sensitivity to contrast-enhanced breast MRI in women with a high suspicion of breast cancer. The aim of this study is to determine the sensitivity of Positron Emission Mammography (PEM) relative to that of Contrast-enhanced breast MRI (CE-MRI) in women with a high suspicion of breast cancer
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 |
|---|---|---|---|
| Breast PET | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Breast PET
- description
- Breast PET
- interventionNames
- Diagnostic Test: Breast PET
Primary outcomes (1)
- measure
- Diagnostic yield of breast cancers detected on PEM compared to MRI
- timeFrame
- One week
- description
- The primary analysis is to compare the PEM diagnostic yield to the MRI diagnostic yield, which is considered the standard for this trial. The primary analysis will use the observed MRI diagnostic yield as the control value. The diagnostic yield of PEM will be estimated with a binomial point estimate and corresponding 95% binomial confidence interval (CI). The point estimate for the diagnostic yield (for both MRI and PEM) will be the number of confirmed breast cancers detected by the imaging (i.e. as determined by the reference standard) divided by the number of eligible and evaluable patients.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
Show eligibility criteria text
Inclusion Criteria: * All women in this study will have recent imaging study (mammogram, tomosynthesis, MBI or ultrasound) interpreted as highly suspicious for malignancy or known biopsy-proven malignancy (BI-RADS Category 5 or 6 within 60 days prior to the MRI or PEM study * Scheduled or will be scheduled for clinically indicated contrast-enhanced breast MRI examination * PEM must be performed within 5 business days, prior to or following the clinical MRI * Participant has signed the study-specific informed consent prior to registration * Age 25 or older Exclusion Criteria: * Unable to understand and sign the consent form * Pregnant or lactating * Physically unable to lie prone for \~20 minutes * Undergone bilateral mastectomy * Weight more than 300 lbs (weight limit on PEM table) * Have contraindications to the clinical MRI examination * Scheduled to undergo breast biopsy or surgery in the time period between the PEM and MRI studies
References
Publications (0)
Data not yet available