Hybrid Molecular Imaging of ER in Breast Cancer Patients With DCIS

NCT03703492 | Completed Phase 2 Results DMC FDA Drug

• 8 other identifiers: UW18063KL2TR000428NCI-2018-022812018-0814A539300SMPH/RADIOLOGY/RADIOLOGYP30CA014520Protocol Version 5/11/2022
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Ductal Carcinoma in Situ - Category

Outcome Measures

Primary Outcomes (1)

• 18F-FES Uptake in DCIS

  18F-FES uptake of biopsy-proven ductal carcinoma in situ (DCIS) measured using PET/MRI will be reported in Standardized Uptake Values (SUV).

  1 day

Secondary Outcomes (5)

• Prognostic Risk Categories Determined Using Van Nuys Prognostic Index, the MSKCC Nomogram

  2 months

• Research-based Oncotype DX DCIS Scores

  12 months

• Number of Participants With Invasive Cancer at Surgical Excision

  2 months

• Serum Estradiol Levels

  1 day

• Serum Sex Hormone Binding Globulin Levels

  1 day

Study Arms (1)

Research Arm

EXPERIMENTAL

Directed breast PET/MRI with 18F-FES; 18F-FES uptake of the known malignancy to be measured on the PET/MRI examination

Drug: (18F)FES; Drug: Gadobenate dimeglumine

Interventions

(18F)FES DRUG

18F-FES is an investigational new drug which will be used for this study. For complete information, please refer to the Investigator's Brochure: "\[18F\]Fluoroestradiol: An investigational positron emission tomography (PET) radiopharmaceutical for injection, intended for use as an in vivo diagnostic for imaging estrogen receptors in tumors

Also known as: 11.2 16α-[18F]-fluoro-17β-estradiol, FES

Research Arm

Gadobenate dimeglumine DRUG

Gadolinium-based intravenous contrast agent used for the MRI portion of this study

Also known as: MultiHance

Research Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Cancer Institute (NCI): collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53705, United States

Location

Related Links

• University of Wisconsin Carbone Cancer Center

MeSH Terms

Conditions

Breast Neoplasms

Interventions

16-fluoroestradiol; gadobenic acid

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Amy Fowler, MD, PhD
• Organization: UW School of Medicine and Public Health

afowler@uwhealth.org

608-262-2122

Study Officials

• Amy Fowler

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 9, 2018
• First Posted: October 12, 2018
• Study Start: January 3, 2019
• Primary Completion: January 2, 2024
• Study Completion: January 2, 2024
• Last Updated: February 12, 2025
• Results First Posted: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)