Clinical trial · Interventional
Study the Role of Positron Emission Mammography in Pre-surgical Planning for Breast Cancer
Prospective Multicenter Study of the Role of Positron Emission Mammography (PEM) in Pre-Surgical Planning for 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)
Women with newly diagnosed breast cancer anticipating breast-conserving surgery are enrolled into the study and will undergo both high-resolution positron emission mammographic (PEM) imaging and contrast-enhanced magnetic resonance imaging (MRI) of the breast(s). The purpose of this study is to determine changes in surgical management resulting from PEM or MRI imaging as compared to conventional imaging and to determine if the changes were appropriate with histopathology as gold standard.
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 |
|---|---|---|---|
| Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
| Positron Emission Mammography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1 PEM
- interventionNames
- Procedure: Positron Emission Mammography
- type
- ACTIVE_COMPARATOR
- label
- 2 MRI
- interventionNames
- Procedure: Magnetic Resonance Imaging
Primary outcomes (1)
- measure
- The primary outcome for this study will be measured by evidence of malignancy on PEM and/or MRI, confirmed by core biopsy or surgery.
- timeFrame
- Within 30 days (plus or minus a week) after core biopsy/surgery
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women who are 25 years of age or older 2. Newly diagnosed core-biopsy proven breast cancer 3. Has current mammography of all study breasts (within prior 3 months), including magnification views of suspicious calcifications (if any) 4. Recent clinical breast examination (within prior 3 months) 5. Has had full diagnostic workup with breast ultrasound (within prior 3 months) as indicated by mammographic and/or clinical findings 6. Has had percutaneous biopsy of all relevant suspicious findings on mammography, clinical examination, and ultrasound 7. After full diagnostic workup, participant is likely to be a candidate for breast conserving surgery. 8. No contraindications to breast MRI: * No pacemaker, aneurysm clip, or other implanted magnetic or ferromagnetic device; * No claustrophobia that cannot be controlled by medication with valium, ativan, or other sedative under her physician's orders; * Has intravenous access; * Weight \< 300 lbs; * Physically able to tolerate positioning in the MRI scanner. 9. Agrees to undergo follow-up MRI or PEM at 6 months and/or MRI-guided vacuum-assisted biopsy, US-guided core biopsy, or PEM-guided biopsy if needed based on results of the MRI or PEM examination 10. Has signed study-specific consent form 11. Subject agrees to undergo a contrast-enhanced MRI and PEM scan within five business days of each other, prior to surgery. Exclusion Criteria: 1. Male 2. Pregnancy 3. Active lactation or discontinued breastfeeding \< 2 months prior 4. Age less than 25 years 5. Inability to provide informed consent 6. Prior radiation treatment to the affected breast(s) 7. Participant is scheduled for sentinel node procedure using radioactive Tc-99m within 24 hours after the scheduled PEM Flex study 8. Women planning prophylactic mastectomy without histologic confirmation 9. Individuals who are electing to undergo neoadjuvant chemotherapy prior to surgery (Note: Patients with prior contralateral breast cancer receiving chemoprevention with Tamoxifen, Arimidex, or other aromatase inhibitor are eligible) 10. Individuals who have had surgery on the study breast(s) within the past 12 months 11. Breast implant(s) in any study breast(s) 12. Women who have had distant metastatic disease either currently or in the past 13. Individuals with Type I or poorly controlled Type II diabetes mellitus 14. Individuals with a blood glucose level that is above 140 mg/dl at the time of PEM imaging 15. Has not had contrast-enhanced breast MRI or PEM within the past 12 months prior to study enrollment 16. Subject is currently enrolled in another breast imaging research study
References
Publications (2)
- BACKGROUNDBerg WA, Weinberg IN, Narayanan D, Lobrano ME, Ross E, Amodei L, Tafra L, Adler LP, Uddo J, Stein W 3rd, Levine EA; Positron Emission Mammography Working Group. High-resolution fluorodeoxyglucose positron emission tomography with compression ("positron emission mammography") is highly accurate in depicting primary breast cancer. Breast J. 2006 Jul-Aug;12(4):309-23. doi: 10.1111/j.1075-122X.2006.00269.x. PMID 16848840
- BACKGROUNDTafra L, Cheng Z, Uddo J, Lobrano MB, Stein W, Berg WA, Levine E, Weinberg IN, Narayanan D, Ross E, Beylin D, Yarnall S, Keen R, Sawyer K, Van Geffen J, Freimanis RL, Staab E, Adler LP, Lovelace J, Shen P, Stewart J, Dolinsky S. Pilot clinical trial of 18F-fluorodeoxyglucose positron-emission mammography in the surgical management of breast cancer. Am J Surg. 2005 Oct;190(4):628-32. doi: 10.1016/j.amjsurg.2005.06.029. PMID 16164937