Clinical trial · Interventional
Positron Emission Mammography (PEM) Biopsy Accessory for the Diagnosis of Breast Cancer
Clinical Utility and Initial Experience With PEM Flex Solo II PET Scanner and Stereo Navigator Biopsy Accessory for the Diagnosis 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 purpose of this research study is to evaluate how well the Stereo Navigator Biopsy Accessory for the PEM Flex solo II PET Scanner works for performing breast biopsy on suspicious lesions. This study will also allow the doctors to describe the features of PEM detected lesions and the results obtained using the PEM guided biopsy and will compare the time it took to complete a pre-operative work up using PEM versus MRI in patients with a suspicious breast lesion resulting in 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 |
|---|---|---|---|
| PEM Breast Biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PEM Breast Biopsy
- description
- All patients underwent PEM biopsy.
- interventionNames
- Procedure: PEM Breast Biopsy
Primary outcomes (1)
- measure
- Feasibility That Breast Biopsy Can be Performed Using PEM and Stereo Navigator Software After Diagnostic PEM on the Same Day.
- timeFrame
- At time of biopsy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
Show eligibility criteria text
Inclusion Criteria: * female * subject is 25-100 years of age * subjects has at least one breast imaging finding on mammography and/or ultrasound which is assessed as highly suggestive of malignancy and recommended to biopsy * subject is able to provide informed consent Exclusion Criteria: * subject is pregnant * subject is actively lactating or discontinued breastfeeding less than 2 months ago * subject has breast implants * subject is scheduled for sentinel node procedure using radioactive Tc-99m within 24 hours of the PEM study * subject has contraindications for core biopsy and other invasive procedures * subject has Type I diabetes mellitus or poorly controlled Type II diabetes mellitus * subject has had surgery or radiation therapy on the study breast or has had chemotherapy within the past 12 months * subject has not fasted for 4-6 hours prior to the procedure and/or have a fasting blood glucose level greater than 140 mg/dl on day of PEM imaging
References
Publications (0)
Data not yet available