Clinical trial · Interventional
Role of Positron Emission Mammography (PEM) Flex Solo II Positron Emission Tomography (PET) Scanner in Evaluating Neoadjuvant Chemotherapy Response in Patients With Breast Cancer
Role of PEM Flex Solo II PET Scanner in Evaluating Neoadjuvant Chemotherapy Response in Patients With Breast Cancer
NCT01012440CI-TRIAL-00018665terminatedN/AResults postedClinicalTrials.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): Poor accrual
Summary
Brief summary (as posted)
The purpose of this study is: 1. To evaluate the hypothesis: Can PEM Flex Solo II PET scanner ascertain response to neoadjuvant chemotherapy in patients with breast cancer? 2. To compare the results from the PEM Flex Solo II PET scanner to the standard of care bilateral breast MRI.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI scan | Device | — | UNRESOLVED |
| PEM Flex Solo II PET Scanner | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Beast cancer subjects
- description
- Subject will have assessment of neoadjuvant chemotherapy treatment response by both MRI and PEM to compare methods
- interventionNames
- Device: PEM Flex Solo II PET Scanner
- Device: MRI scan
Primary outcomes (1)
- measure
- Reduction in Tumor Size
- timeFrame
- 1-2 weeks post treatment onset
- description
- Comparison of tumor size pre chemotherapy and post chemotherapy represents the PEM data. There is no the response with MRI because the study was aborted and very few patients were involved.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Women 18-75 years old with newly diagnosed breast cancer who are considered candidates for breast conserving surgery (i.e., lumpectomy) Exclusion Criteria: * Children (\< 18 years old) * Pregnant or Lactating women * Diabetic patients (Type I or II) * Patients who are scheduled for a sentinel node procedure using radioactive Tc-99m within 24 hours of PEM * Patients who have NOT undergone a standard of care bilateral breast MRI
References
Publications (0)
Data not yet available
No reference posted for this study.