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 range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.