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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05068726
Other study ID # GE-280-401
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 5, 2023
Est. completion date October 2, 2025

Study information

Verified date January 2024
Source Zionexa
Contact Jessica Clancy
Phone (978) 243-7447
Email jessica.clancy@ge.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 206
Est. completion date October 2, 2025
Est. primary completion date October 2, 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 99 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
18F Fluoroestradiol Radiopharmaceutical with PET/CT
Administration of one dose of 18F FES for PET/CT imaging

Locations

Country Name City State
United States St. Luke's University Health Network Allentown Pennsylvania
United States Emory University Atlanta Georgia
United States WakeMed Cary North Carolina
United States TOI Clinical Research Cerritos California
United States University of Virginia Charlottesville Virginia
United States Baylor Research Institute d/b/a Baylor Scott & White Research Institute Dallas Texas
United States City of Hope Comprehensive Cancer Center Duarte California
United States Duke University Durham North Carolina
United States Northern Arizona Healthcare Flagstaff Arizona
United States Kettering Health Cancer Center Kettering Ohio
United States Long Beach Memorial Medical Center Long Beach California
United States University of Southern California Los Angeles California
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 Hoag Memorial Hospital Presbyterian Newport Beach California
United States University of Pennsylvania / Perelman Center for Advanced Medicine Philadelphia Pennsylvania
United States Magee-Womens Hospital of UPMC Pittsburgh Pennsylvania
United States Blue Ridge Cancer Care Roanoke Virginia
United States PET/CT Imaging of San Jose San Jose California
United States Providence Saint John's Health Center Santa Monica California
United States Fred Hutchinson Cancer Center Seattle Washington
United States MD Clinics Shreveport Louisiana
United States Tampa General Hospital Cancer Institute Tampa Florida
United States Valley Breast Care Van Nuys California

Sponsors (4)

Lead Sponsor Collaborator
Zionexa GE Healthcare, Medpace, Inc., Simbec-Orion Group

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate change in therapeutic management plan assessed by comparing pre/post-Cerianna PET/CT treatment selection (based on comparison of the initial management plan and post-Cerianna PET/CT management plan evaluated within 3 weeks). The percentage of subjects with changes in the therapeutic management plan after Cerianna PET/CT with 95% confidence interval will be estimated by comparison of the initial management plan vs. the post-Cerianna PET/CT management plan evaluated within 3 weeks after Cerianna PET/CT. [Time Frame: Baseline and within 3 weeks after Cerianna PET/CT
Secondary Number and percentage of lesions detected with Cerianna PET/CT (focal Cerianna uptake, outside the liver, visible above background) in individual patients. Cerianna-uptake score per patient, defined as total number of Cerianna-positive lesions divided by all lesions visible on standard-of-care imaging (e.g., CT and/or bone scan, or FDG-PET/CT) and Cerianna PET/CT (lower scores represent greater ER heterogeneity/ER loss; 0 = a negative scan) Time Frame: Baseline, Cerianna PET/CT
Secondary SUV Standard uptake values (SUVs, incl. SUVmax, SUVmean, SUVpeak) of each measurable lesion on Cerianna PET/CT and the inter-lesion variability of Cerianna uptake in individual patients Time Frame: Baseline, Cerianna PET/CT
Secondary Heterogeneity Association between Cerianna heterogeneity scores (inter-lesion SUV variability and Cerianna-uptake score) and patients with/without change in therapeutic management plan Time Frame: baseline Cerianna PET/CT and within 3 weeks after Cerianna PET/CT
Secondary Confidence Treating physician's confidence level in the therapeutic management plan (measured on a 10-point scale) and the percent change in confidence level before and after Cerianna PET/CT Time Frame: baseline and within 3 weeks after Cerianna PET/CT
Secondary Change in management Proportion of patients with a change in actual therapeutic management assessed by comparing the therapeutic management plans to the actual therapeutic management at 6 months and 18 months after Cerianna PET/CT Timeframe: baseline, 6 months and 18 months after Cerianna PET/CT
Secondary PFS PFS rate at 6 and 18 months based on heterogeneity in tumor Cerianna uptake. Comparison will be made between patients with and without a change in therapeutic management plan Timeframe: baseline, 6 months and 18 months after Cerianna PET/CT
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