Clinical trial · Interventional
Pre-Surgery Positron Emission Mammography in Patients With Newly Diagnosed Breast Cancer
Clinical Value of Pre-Surgery Positron Emission Mammography (PEM) in Patients With Newly Diagnosed Breast Cancer
NCT01241721CI-TRIAL-00024840completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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 purpose of the study is to determine the optimal, lowest dose of radioactive tracer required for Positron Emission Mammography (PEM), and the accuracy and reliability of PEM in pre-surgical evaluations for patients with newly diagnosed breast cancer anticipating breast-conserving surgery but identified to have a second unsuspected breast cancer by MRI.
Conditions
Conditions (2)
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 |
| Breast Cancer Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Positron Emission Mammography (PEM) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Positron Emission Mammography (PEM)
- description
- Positron Emission Mammography (PEM)
- interventionNames
- Device: Positron Emission Mammography (PEM)
Primary outcomes (1)
- measure
- PEM identification of primary breast cancer.
- timeFrame
- Upon study completion (~3 years)
Secondary outcomes (4)
- measure
- Lowest dose of F18-FDG giving optimal PEM imaging of primary breast cancers.
- timeFrame
- After the first 30 subjects (~one year)
- measure
- Identification of 2nd unsuspected primary breast cancer by PEM in patients with known index primary breast cancer.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Must be 18 years of age or older * Newly diagnosed primary breast cancer * Must have a breast or breast/chest MRI ordered as part of standard of care * Must meet one or more of the following in Part 1: * T1 carcinoma of the breast appropriate for breast conserving surgery diagnosis established by core biopsy * Tis (ductal carcinoma in situ) carcinoma \> 2 cm diameter * Invasive lobular carcinoma of the breast * Must meet the following in Part 2: * Known invasive or in situ primary breast cancer identified on pre-surgical breast MRI to have an unsuspected 2nd lesion recommended for biopsy and biopsy has not yet been performed Exclusion Criteria: * Known diabetes mellitus
References
Publications (0)
Data not yet available
No reference posted for this study.