Phase 2
N=12
Hybrid Molecular Imaging of ER in Breast Cancer Patients With DCIS
Breast Cancer · Ductal Carcinoma in Situ - Category
Bottom Line
View on ClinicalTrials.gov: NCT03703492 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: 18F-FES Uptake in DCIS — 1.43 SUV
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- (18F)FES (Drug); Gadobenate dimeglumine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 18F-FES Uptake in DCIS |
1.43 | — |
| SECONDARY Prognostic Risk Categories Determined Using Van Nuys Prognostic Index, the MSKCC Nomogram |
NA | — |
| SECONDARY Research-based Oncotype DX DCIS Scores |
— | — |
| SECONDARY Number of Participants With Invasive Cancer at Surgical Excision |
2 | — |
| SECONDARY Serum Estradiol Levels |
31.3 | — |
| SECONDARY Serum Sex Hormone Binding Globulin Levels |
64.4 | — |
Summary
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.
Eligibility Criteria
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.)
Data sourced from ClinicalTrials.gov (NCT03703492). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.