Hybrid Molecular Imaging of ER in Breast Cancer Patients With DCIS (NCT03703492) | Clinical Trial Compass
CompletedPhase 2
Hybrid Molecular Imaging of ER in Breast Cancer Patients With DCIS
United States12 participantsStarted 2019-01-03
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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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 p…