Clinical trial · Interventional
Hybrid Molecular Imaging of ER in Breast Cancer Patients With DCIS
Positron Emission Tomography/Magnetic Resonance Imaging of Estrogen Receptor Expression n Non-Invasive 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)
This prospective, one-arm study which will enroll participants with biopsy-proven DCIS scheduled for diagnostic breast MRI for preoperative staging/extent of disease evaluation as part of standard of care. Eligible participants will be consented for participation in the research study which includes a directed breast PET/MRI with 18F-FES. 18F-FES uptake of the known malignancy will be measured on the PET/MRI examination using standardized uptake values (SUV) and tumor-to-normal tissue ratios.
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 |
| Ductal Carcinoma in Situ - Category | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| (18F)FES | Drug | — | UNRESOLVED |
| Gadobenate dimeglumine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Research Arm
- description
- Directed breast PET/MRI with 18F-FES; 18F-FES uptake of the known malignancy to be measured on the PET/MRI examination
- interventionNames
- Drug: (18F)FES
- Drug: Gadobenate dimeglumine
Primary outcomes (1)
- measure
- 18F-FES Uptake in DCIS
- timeFrame
- 1 day
- description
- 18F-FES uptake of biopsy-proven ductal carcinoma in situ (DCIS) measured using PET/MRI will be reported in Standardized Uptake Values (SUV).
Secondary outcomes (5)
- measure
- Prognostic Risk Categories Determined Using Van Nuys Prognostic Index, the MSKCC Nomogram
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of biopsy-proven DCIS without invasion or microinvasion measuring at least 1.0 cm in diameter by any imaging modality * Undergoing diagnostic breast MRI ordered by the referring clinician for staging and extent of disease Exclusion Criteria: * Inability or unwillingness to provide informed consent to the study * Surgery, radiation, neoadjuvant chemo/endocrine therapy for the current malignancy prior to study enrollment * Participants currently taking or have taken an ER-blocking medication (e.g. tamoxifen, raloxifene) within 6 weeks prior to study enrollment * Pregnant or lactating women * Participant with intolerance or contraindications for MRI or gadolinium-based contrast agents * Participant girth exceeds the bore of the MRI/PET scanner * Participants with a history of allergic reaction attributable to compounds of similar chemical or biologic composition to 18F-FES * Participants in liver failure as judged by the patient's physician, due to the hepatobiliary clearance of 18F-FES * Participants requiring intravenous (IV) conscious sedation for imaging are not eligible; participants requiring mild, oral anxiolytics for the clinical MRI will be allowed to participate as long as the following criteria are met: * The participant has their own prescription for the medication * The informed consent process is conducted prior to the self-administration of this medication * They come to the research visit with a driver or an alternative plan for transportation (e.g. Uber, taxi, etc.)
References
Publications (0)
Data not yet available