Clinical trial · Interventional
Estrogen Receptor Expression in Breast Cancer - Assessed With Positron Emission Mammography
Assessment of the Heterogeneity of Estrogen Receptor Expression in Patients With Estrogen Receptor Positive Breast Cancer Using F-18 Fluoroestradiol and High Resolution Positron Emission Mammography
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): unable to recruit patients due to competing studies
Summary
Brief summary (as posted)
The primary objective of this study is to determine the correlation between the distribution of F-18 FES within ER+ breast tumors as seen on Positron Emission Mammography (PEM) images of the breast, and the distribution of cells stained ER+ within the tumor by immunohistochemistry (IHC) measurements at surgical pathology. The secondary aim is to determine if the correlation (or lack of) between F-18 FES uptake and F-18 FDG uptake as imaged by PEM, is an accurate representation of the heterogeneity of ER expression in the tumor.
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 Neoplasm | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| F-18 FDG | Diagnostic Test | — | UNRESOLVED |
| F-18 FES | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- FES vs FDG
- description
- All patients will undergo two PEM studies, one with F-18 FDG and the second with F-18 FES. Co-registration of the PEM images from F-18 FDG and F-18 FES will be used to assess the heterogeneity of uptake of the F-18 FES relative to that of F-18 FDG. Heterogeneity of ER expression in the tumor will be determined by immunohistochemistry on the pathologic tissue
- interventionNames
- Diagnostic Test: F-18 FES
- Diagnostic Test: F-18 FDG
Primary outcomes (1)
- measure
- correlation of FES and estrogen receptors
- timeFrame
- 1 year
- description
- The primary objective of this study is to determine the correlation between F-18 FES uptake on PEM, and distribution of ER+ tissue on pathology
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: Eligible patients will be offered enrollment if the time interval between initial diagnosis and surgery allows for performance of the PEM studies with both F18 FDG and F-18 FES, and they meet the following criteria: * Postmenopausal women, as defined by * Lack of menstrual periods for ≥ 12 months * For women with prior hysterectomy and age \< 60, a serum FSH level within the postmenopausal range * Histologic proof of invasive breast carcinoma that is ER positive per ASCO/CAP guidelines (staining in ≥ 1% of cells by immunohistochemistry) * Extent of disease confirmed, or to be confirmed, on a clinical contrast-enhanced breast MRI examination * Minimum size criteria for index cancer of 10 mm as measured on mammogram, ultrasound, or MRI. * Planned surgical excision of the breast cancer at Mayo Clinic, Rochester Exclusion Criteria: Patients are excluded if they meet any of the following criteria: * Premenopausal * Unable to undergo PEM scanning (weight limit of 300 lbs. on PEM system or inability to lie prone for 30 minutes) * Total serum bilirubin \> 1.5 x upper limit of normal (abnormal hepatic metabolism may interfere with FES hepatic excretion), * Serum creatinine \> 1.5 x upper limit of normal * Patients who have received, are currently receiving, or planning to receive neoadjuvant systemic therapy prior to surgical excision * Patients who will undergo core needle biopsy of the breast or axilla between the breast MRI and investigational PEM studies. NOTE: Axillary ultrasound with or without fine needle aspiration of an axillary mass or lymph node is allowed. * Patients with breast implants?
References
Publications (0)
Data not yet available