Clinical trial NCT03703492: Hybrid Molecular Imaging of ER in Breast Cancer Patients With DCIS
Official title: Positron Emission Tomography/Magnetic Resonance Imaging of Estrogen Receptor Expression n Non-Invasive Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Ductal Carcinoma in Situ - Category
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2018-10-12
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective, one-arm, observational 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.
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed description: Integrated whole-body magnetic resonance imaging (MRI)-positron emission tomography (PET) scanners have recently been introduced for clinical use. This technology combines the anatomic and perfusion data obtained with Dynamic Contrast Enhanced (DCE) MRI with functional imaging data obtained from PET. For breast imaging, the combination of MRI and PET has important potential to improve diagnostic accuracy and provide molecular characterization of breast cancer. The overall purpose of this research is to determine the technical feasibility of simultaneous breast DCE MRI with 18F-FES PET for measuring estrogen receptor (ER) in patients with ductal carcinoma in situ (DCIS) and identifying patients with low-risk of disease recurrence. The hypothesis is that quantitative 18F-FES uptake parameters from PET/MRI will correlate well with the ER immunohistochemistry score and with low-risk recurrence scores.

Primary Objective 1) To compare quantitative 18F-FES uptake of biopsy-proven DCIS measured using PET/MRI with ER protein levels determined by immunohistochemistry.

Secondary Objectives

1. To determine the optimal cut-point 18F-FES uptake value for distinguishing between ER+ and ER-negative DCIS
2. To determine the test-retest reproducibility of quantitative assessment of tumor 18F-FES uptake
3. To determine the optimal cut-point 18F-FES uptake value for distinguishing between low-risk DCIS and intermediate/high-risk DCIS
4. To estimate the association of quantitative 18F-FES uptake (continuous SUVmax) with research-based Oncotype DX DCIS scores (0-100)
5. To measure the upgrade rate to invasive cancer at surgical excision
6. To correlate tumor 18F-FES uptake with serum estradiol and sex hormone binding globulin levels.

Exploratory Objective

1) To correlate tumor cell density with 18F-FES uptake on PET/MRI

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.)

Primary outcomes:
measure: 18F-FES Uptake in DCIS
timeFrame: 1 day
Secondary outcomes:
measure: Prognostic Risk Categories Determined Using Van Nuys Prognostic Index, the MSKCC Nomogram
timeFrame: 2 months
measure: Research-based Oncotype DX DCIS Scores
timeFrame: 12 months
measure: Number of Participants With Invasive Cancer at Surgical Excision
timeFrame: 2 months
measure: Serum Estradiol Levels
timeFrame: 1 day
measure: Serum Sex Hormone Binding Globulin Levels
timeFrame: 1 day
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Amy Fowler
role: PRINCIPAL_INVESTIGATOR
References: