Metastatic Breast CancerNCT05068726
Clinical Utility of FES F18 PET/CT in Metastatic Breast Cancer Patients
An observational study of Metastatic Breast Cancer, run by GE Healthcare at 24 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- 18F Fluoroestradiol Radiopharmaceutical with PET/CT
- How many people
- 51 participants
- Where
- 24 sitesUnited States
- Study dates
- 5 Jan 2023to 1 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Metastatic Breast Cancer Patients with ER-Positive and HER2-Negative Primary Lesions after Progression on First Line Hormonal Therapy
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
St. Luke's University Health Network
Allentown, Pennsylvania, 18102
Emory University
Atlanta, Georgia, 30322
WakeMed
Cary, North Carolina, 27610
TOI Clinical Research
Cerritos, California, 90703
University of Virginia
Charlottesville, Virginia, 22903
Baylor Research Institute d/b/a Baylor Scott & White Research Institute
Dallas, Texas, 75204
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Duke University
Durham, North Carolina, 27705
Northern Arizona Healthcare
Flagstaff, Arizona, 86001
Kettering Health Cancer Center
Kettering, Ohio, 45429
Long Beach Memorial Medical Center
Long Beach, California, 90806
University of Southern California
Los Angeles, California, 90033
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
The New York Presbyterian Hospital-Columbia University Medical Center
New York, New York, 10032
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
University of Pennsylvania / Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
Blue Ridge Cancer Care
Roanoke, Virginia, 24014
PET/CT Imaging of San Jose
San Jose, California, 95128
Providence Saint John's Health Center
Santa Monica, California, 90404
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
MD Clinics
Shreveport, Louisiana, 71104
Tampa General Hospital Cancer Institute
Tampa, Florida, 33606
Valley Breast Care
Van Nuys, California, 91405
About this study
Official title: Clinical Utility of Fluoroestradiol F18 PET/CT in Metastatic Breast Cancer Patients With ER-Positive and HER2-Negative Primary Lesions After Progression on First Line Hormonal Therapy
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
- Being tested
- 18F Fluoroestradiol Radiopharmaceutical with PET/CT
- Keywords
- Metastatic breast cancer, PET/CT, Cerianna, FES, Fluoroestradiol F-18
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F Fluoroestradiol Radiopharmaceutical with PET/CTDrug
Also called Cerianna
Administration of one dose of 18F FES for PET/CT imaging
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: [Time Frame: Baseline and within 3 weeks after Cerianna PET/CT
Secondary outcomes (6)
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)
Measured: Time Frame: Baseline, Cerianna PET/CT
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
Measured: Time Frame: Baseline, Cerianna PET/CT
Heterogeneity
Association between Cerianna heterogeneity scores (inter-lesion SUV variability and Cerianna-uptake score) and patients with/without change in therapeutic management plan
Measured: Time Frame: baseline Cerianna PET/CT and within 3 weeks after Cerianna PET/CT
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
Measured: Time Frame: baseline and within 3 weeks after Cerianna PET/CT
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
Measured: Timeframe: baseline, 6 months and 18 months after Cerianna PET/CT
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
Measured: Timeframe: baseline, 6 months and 18 months after Cerianna PET/CT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start5 Jan 2023
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Why it stopped: Sponsor discretion (low recruitment rate)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Simbec-Orion Group, Medpace, Inc., Zionexa
- Responsible party
- Sponsor
- Investigators
- Stephanie van de Ven, Study director, GE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068726
- Sponsor's protocol ID
- GE-280-401
- Status last verified
- Jul 2024
- First submitted
- 24 Sep 2021
- Last updated
- 31 Jul 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Utility of Fluoroestradiol F18 PET/CT in Metastatic Breast Cancer Patients With ER-Positive and HER2-Negative Primary Lesions After Progression on First Line Hormonal Therapy
- ClinicalTrials.gov ID
- NCT05068726
- Acronym / sponsor ID
- GE-280-401
- Conditions
- Metastatic Breast Cancer
- Keywords
- Metastatic breast cancer, PET/CT, Cerianna, FES, Fluoroestradiol F-18
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor discretion (low recruitment rate)
- Enrolment
- 51 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- Simbec-Orion Group, Medpace, Inc., Zionexa
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 6 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Metastatic Breast Cancer Patients with ER-Positive and HER2-Negative Primary Lesions after Progression on First Line Hormonal Therapy
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F Fluoroestradiol Radiopharmaceutical with PET/CTAlso: CeriannaAdministration of one dose of 18F FES for PET/CT imaging | Drug | – |
Primary outcome
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).
Time frame: [Time Frame: Baseline and within 3 weeks after Cerianna PET/CT
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.
6 secondary outcomes
Number and percentage of lesions detected with Cerianna PET/CT (focal Cerianna uptake, outside the liver, visible above background) in individual patients.
Time frame: Time Frame: Baseline, Cerianna PET/CT
SUV
Time frame: Time Frame: Baseline, Cerianna PET/CT
Heterogeneity
Time frame: Time Frame: baseline Cerianna PET/CT and within 3 weeks after Cerianna PET/CT
Confidence
Time frame: Time Frame: baseline and within 3 weeks after Cerianna PET/CT
Change in management
Time frame: Timeframe: baseline, 6 months and 18 months after Cerianna PET/CT
PFS
Time frame: Timeframe: baseline, 6 months and 18 months after Cerianna PET/CT
Results and safety
The study was stopped early (reason given: Sponsor discretion (low recruitment rate)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie van de Ven study director
GE Healthcare
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Breast Cancer, run by GE Healthcare at 24 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor discretion (low recruitment rate)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: [Time Frame: Baseline and within 3 weeks after Cerianna PET/CT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.