Clinical Utility of FES F18 PET/CT in Metastatic Breast Cancer Patients

NCT ID: NCT05068726

Last Updated: 2024-07-31

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 51 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-05
• Study Completion Date: 2024-06-01

Brief Summary

This is a phase 4, multi-center, open-label, prospective cohort study to evaluate the clinical utility of Fluoroestradiol F18 (Cerianna) PET/CT to guide therapeutic management in ER-positive, HER2-negative metastatic breast cancer patients with progressive disease on first-line standard-of-care hormonal therapy. All patients will undergo a Cerianna PET/CT scan. The treating physician will complete a standardized questionnaire to indicate the second-line therapeutic management plan before the scheduled Cerianna PET/CT. After interpretation of Cerianna PET/CT by local radiologist or nuclear medicine physician, the treating physician will fill out a similar questionnaire to specify the final therapeutic decision. The proportion of patients with a change in therapeutic management plan based on Cerianna PET/CT results will be the primary endpoint. During the study follow-up period of 18 months, data on standard-of-care imaging, treatments/procedures received, and clinical outcomes will be collected. Patients will be asked to complete a health-related quality of life questionnaire at their screening, 6-month, and 18-month visit. Secondary endpoints include visual and quantitative heterogeneity assessment of tumor Cerianna uptake, and PFS rates at 6 months and 18 months after Cerianna PET/CT, which will be assessed between patients with and without a change in therapeutic management plan. Maximum duration of follow-up for each patient: 20 months. First patient first visit to last patient last visit: estimated 36 months.

Conditions

Metastatic Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

18F Fluoroestradiol Radiopharmaceutical with PET/CT

Administration of one dose of 18F FES for PET/CT imaging

Intervention Type: DRUG

Other Intervention Names

Cerianna

Eligibility Criteria

Inclusion Criteria

• Patient must sign informed consent prior to enrollment in this trial
• The patient is a female ≥18 years old
• Post-menopausal or pre-menopausal patient with known primary breast tumor(s) expressing ER in ≥1% of tumor cells by IHC
• HER2-negative (0, 1+, 2+ fluorescence in situ hybridization (FISH) negative) primary lesion
• MBC with at least 1 identifiable lesion on standard-of-care imaging assessment, outside of the liver, as confirmed by the investigator site
• Patient with progressive disease on 1st line hormonal therapy (Aromatase Inhibitor) with or without a CDK4/6 inhibitor or mechanistic target of rapamycin (mTOR) inhibitor or phosphoinositide 3-kinases (PI3K) inhibitor
• Patient must score at least 0, 1 or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status
• Life expectancy of at least 12 months
• The patient is planned to undergo a standard-of-care imaging scan (according to National Comprehensive Cancer Network guidelines, e.g., CT and/or bone scan, or fluorodeoxyglucose [FDG]-PET/CT) covering chest, abdomen, and pelvis after date of consent and before Cerianna PET/CT (Visit 2), or the patient has undergone recent standard-of-care imaging before date of consent and is planned to undergo Cerianna PET/CT (Visit 2) no more than 45 days from the standard-of-care imaging scan

Exclusion Criteria

• Isolated hepatic metastases (taking into account the physiological hepatic high uptake of Cerianna)
• Patient is on tamoxifen/toremifene treatment without 8-week washout, or on fulvestrant treatment without 28-week washout, (may block ER) before Cerianna PET/CT
• Other evolutive malignant disease (non-melanoma skin cancer is allowed) or acute or chronic infectious disease (well-controlled infectious disease is allowed);
• Patient has a history of administered chemotherapy for metastatic disease; prior chemotherapy in the (neo)adjuvant setting is allowed
• Patient with a known allergy to any of the components of Cerianna
• Woman of childbearing age who is not using effective contraception
• Pregnant woman (per the Product Label and ensured using clinic's standard-of-care), or parturient or nursing mother
• Patient presents with any other clinically active, serious, life-threatening disease, medical, or psychiatric condition, and/or who has a life expectancy of <12 months, or for whom study participation may compromise their management; and/or a patient who the investigator judges to be unsuitable for participation in the study for any reason
• Inability to comply with any requirements of the protocol

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Simbec-Orion Group

INDUSTRY

Sponsor Role: collaborator

Medpace, Inc.

INDUSTRY

Sponsor Role: collaborator

Zionexa

INDUSTRY

Sponsor Role: collaborator

GE Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephanie van de Ven

Role: STUDY_DIRECTOR

GE Healthcare

Locations

Northern Arizona Healthcare

Flagstaff, Arizona, United States

TOI Clinical Research

Cerritos, California, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Long Beach Memorial Medical Center

Long Beach, California, United States

University of Southern California

Los Angeles, California, United States

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

PET/CT Imaging of San Jose

San Jose, California, United States

Providence Saint John's Health Center

Santa Monica, California, United States

Valley Breast Care

Van Nuys, California, United States

Tampa General Hospital Cancer Institute

Tampa, Florida, United States

Emory University

Atlanta, Georgia, United States

MD Clinics

Shreveport, Louisiana, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

The New York Presbyterian Hospital-Columbia University Medical Center

New York, New York, United States

WakeMed

Cary, North Carolina, United States

Duke University

Durham, North Carolina, United States

Kettering Health Cancer Center

Kettering, Ohio, United States

St. Luke's University Health Network

Allentown, Pennsylvania, United States

University of Pennsylvania / Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, United States

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, United States

Baylor Research Institute d/b/a Baylor Scott & White Research Institute

Dallas, Texas, United States

University of Virginia

Charlottesville, Virginia, United States

Blue Ridge Cancer Care

Roanoke, Virginia, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Countries

United States

Other Identifiers

GE-280-401

Identifier Type: -

Identifier Source: org_study_id