Breast CancerPhase 4NCT06072807
Brain [18F]-FES PET/CT in Patients With Estrogen-Receptor Positive Breast Cancer
A Phase 4 study testing Brain Imaging with 18F-FES in people with Breast Cancer and Brain Metastases, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The goal of this interventional study is to optimize the protocol of FES PET/CT in Estrogen Receptor positive Breast cancer patients with Brain metastases. Patients will undergo MRI of the brain and FDG PET/CT brain as part of standard of care for radiation treatment planning. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Brain Metastases
- What is being tested?
- Brain Imaging with 18F-FES
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Dec 2023to Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Active diagnosis of ER+ breast cancer (biopsy proven) and new or recurrent brain metastases (biopsy proven or suspected based on MRI appearance)
- Ability to provide informed consent
- Discontinuation of ER modulators for at least 8 weeks, and discontinuation of ER down regulators for at least 28 weeks (as per manufacturer guidelines)
- Age >=18 years
- Eastern Cooperative Oncology Group performance score 0-1
- Life expectancy >=6 months
- Planned for radiation treatment for brain metastases
Who cannot join
- Pregnancy
- Unable to undergo Standard of Care
- Allergy to FES.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
New York-Presbyterian/Weill Cornell Medical Center
New York, New York, 10021
Jana Ivanidze, MD/PhD, 212-746-4587, jai9018@med.cornell.edu
Jana Ivanidze, MD/PhD
About this study
Official title: Brain [18F]-FES PET/CT in the Diagnosis, Treatment Planning and Response Assessment of Brain Metastases in Patients With Estrogen-Receptor Positive Breast Cancer
The goal of this interventional study is to optimize the protocol of FES PET/CT in Estrogen Receptor positive Breast cancer patients with Brain metastases. Patients will undergo MRI of the brain and FDG PET/CT brain as part of standard of care for radiation treatment planning. An additional 18F-FES PET/CT brain scan will be completed before this standard of care radiation treatment. Patients will be followed prospectively with clinical and MRI assessments per standard-of-care for a total of 12 months.
Study Population: Patients with ER-positive breast cancer with biopsy proven or suspected new or recurrent brain metastases (based on standard of care MRI) planned for radiation treatment of brain lesions.
Read the detailed description
Objectives
- Evaluate the kinetics of dynamic brain FES PET/CT and optimize acquisition protocol.
- Evaluate utility of FES PET/CT as an adjunct modality in radiotherapy planning.
- (Exploratory aim) Determine correlation between FES PET metrics and survival metrics.
Overall Design All subjects will undergo a MRI brain and FDG PET/CT brain scan as part of clinical standard- of-care for radiation treatment planning. An additional 18F-FES PET/CT brain scan will be performed as part of this study prior to standard of care radiation treatment. 18F-FES is clinically approved for the study population, however has to date not been widely used in the clinical context of differentiating brain metastases from radiation sequela. The 18F-FES PET/CT scan will be completed within approximately 2 days to 4 weeks of the 18F-FDG PET/CT, and 2 days to 4 weeks of the MRI brain, respectively. While MRI and PET can be performed on the same day if needed, the 18F-FDG PET/CT and 18F-FES PET/CT have to be separated by at least 1 day, to allow for 10 half-lives of 18F (10 times 108 minutes = 18 hours) to pass in order to avoid signal overlap on the second PET/CT scan. Subjects will be followed prospectively with clinical and MRI assessments per clinical standard-of-care for a total of 12 months.
Aim 1
- 5 mCi FES +/- 10% will be injected intravenously (per manufacturer's recommendations). FES PET/CT will be obtained in dynamic 3D list mode for 90 minutes starting from injection.
- Kinetic analysis of dynamic PET images will be carried out using a reversible 1-tissue-2- compartment model as well as Logan Vt, and the influx rate constant, Ki, and distribution volume, Vt, will measured respectively.
- Static 10min PET images will be generated for from 50 to 80 min on a 10min increment, and the corresponding SUV's and tumor-to-background ratios will be compared to that in the 80- 90min imageset, a workflow that previously established by our group using DOTATATE PET/MR in meningioma, and using FLT/FMISO PET/CT in high-grade glioma.
- Tumor volume will be delineated using PMOD (PMOD, Zurich), a dedicated tool for PET analyses and kinetic modeling.
Aim 2.
- To evaluate utility of FES PET/CT in RT planning, planning treatment volumes will be delineated by a radiation oncologist in conjunction with a neurosurgeon based on MRI (gold standard); subsequently, the FES PET/CT data will be made available to the radiation oncologist, and the planning treatment volume (PTV) will be modified accordingly if necessary.
- The clinical treatment plan will be modified (as a proof-of-concept) based on the MRI+FES PTV, and the target dose volume histograms (DVH) will be compared to the MRI-based (gold standard).
- Change in management based on additional information provided in the PET data will be recorded. In an exploratory analysis, FES PET will be compared with standard of care FDG PET/CT or PET/MR for treatment planning.
- Conditions
- Breast Cancer, Brain Metastases
- Being tested
- Brain Imaging with 18F-FES
- Medical subject headings
- Breast Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Imaging with 18F-FESDiagnostic test
Using 18F-FES radiotracer in PET/CT scan to evaluate brain metastases in ER positive breast cancer patients.
| Study group | Role | What they receive |
|---|---|---|
| ER Positive Breast Cancer Patients with Brain Metastases | Experimental | A diagnostic intervention where this group will undergo an additional 18F- FES PET/CT scan in addition to their standard of care MRI and FDG PET/CT scan. Receives: Diagnostic Test: Brain Imaging with 18F-FES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean SUV
Mean standardized uptake value within a region of interest placed based on MRI findings of suspicious brain lesion.
Measured: 3 years
Maximum SUV
Maximum standardized uptake value within a region of interest placed based on MRI findings of suspicious brain lesion.
Measured: 3 years
SUV Ratio
Standardized uptake value ratio of target lesion over reference region.
Measured: 3 years
Target-to-Background Ratio
Qualitative appearance of lesion delineation on PET.
Measured: 3 years
Influx (Ki)
Parametric PET analysis results within the same region of interest as that for Maximum SUV.
Measured: 3 years
Distribution volume (Vt) for scan times
Distribution volume (Vt), measured within the same region of interest as that for Maximum SUV, for scan times ranging between 45 min and 85 min with 5min intervals and corresponding results will be compared to those measured with the full dataset at 90mm.
Measured: 3 years
Secondary outcomes (1)
Proportion of cases in which there was a change in management based on FES PET/CT
We will compare RT plans devised based on contrast-enhanced brain MRI alone (gold standard) to RT plans incorporating FES PET/CT as an adjunct modality and will quantify the proportion of cases in which there was a change in management based on FES PET/CT.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start27 Dec 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- Responsible party
- Sponsor
- Investigators
- Jana Ivanidze, MD/PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06072807
- Sponsor's protocol ID
- 23-02025733
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2023
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain [18F]-FES PET/CT in the Diagnosis, Treatment Planning and Response Assessment of Brain Metastases in Patients With Estrogen-Receptor Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT06072807
- Acronym / sponsor ID
- 23-02025733
- Conditions
- Breast Cancer, Brain Metastases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- 27 Dec 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Oct 2023 (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.
The goal of this interventional study is to optimize the protocol of FES PET/CT in Estrogen Receptor positive Breast cancer patients with Brain metastases. Patients will undergo MRI of the brain and FDG PET/CT brain as part of standard of care for radiation treatment planning. An additional 18F-FES PET/CT brain scan will be completed before this standard of care radiation treatment. Patients will be followed prospectively with clinical and MRI assessments per standard-of-care for a total of 12 months.
Study Population: Patients with ER-positive breast cancer with biopsy proven or suspected new or recurrent brain metastases (based on standard of care MRI) planned for radiation treatment of brain lesions.
Detailed description
Objectives
- Evaluate the kinetics of dynamic brain FES PET/CT and optimize acquisition protocol.
- Evaluate utility of FES PET/CT as an adjunct modality in radiotherapy planning.
- (Exploratory aim) Determine correlation between FES PET metrics and survival metrics.
Overall Design All subjects will undergo a MRI brain and FDG PET/CT brain scan as part of clinical standard- of-care for radiation treatment planning. An additional 18F-FES PET/CT brain scan will be performed as part of this study prior to standard of care radiation treatment. 18F-FES is clinically approved for the study population, however has to date not been widely used in the clinical context of differentiating brain metastases from radiation sequela. The 18F-FES PET/CT scan will be completed within approximately 2 days to 4 weeks of the 18F-FDG PET/CT, and 2 days to 4 weeks of the MRI brain, respectively. While MRI and PET can be performed on the same day if needed, the 18F-FDG PET/CT and 18F-FES PET/CT have to be separated by at least 1 day, to allow for 10 half-lives of 18F (10 times 108 minutes = 18 hours) to pass in order to avoid signal overlap on the second PET/CT scan. Subjects will be followed prospectively with clinical and MRI assessments per clinical standard-of-care for a total of 12 months.
Aim 1
- 5 mCi FES +/- 10% will be injected intravenously (per manufacturer's recommendations). FES PET/CT will be obtained in dynamic 3D list mode for 90 minutes starting from injection.
- Kinetic analysis of dynamic PET images will be carried out using a reversible 1-tissue-2- compartment model as well as Logan Vt, and the influx rate constant, Ki, and distribution volume, Vt, will measured respectively.
- Static 10min PET images will be generated for from 50 to 80 min on a 10min increment, and the corresponding SUV's and tumor-to-background ratios will be compared to that in the 80- 90min imageset, a workflow that previously established by our group using DOTATATE PET/MR in meningioma, and using FLT/FMISO PET/CT in high-grade glioma.
- Tumor volume will be delineated using PMOD (PMOD, Zurich), a dedicated tool for PET analyses and kinetic modeling.
Aim 2.
- To evaluate utility of FES PET/CT in RT planning, planning treatment volumes will be delineated by a radiation oncologist in conjunction with a neurosurgeon based on MRI (gold standard); subsequently, the FES PET/CT data will be made available to the radiation oncologist, and the planning treatment volume (PTV) will be modified accordingly if necessary.
- The clinical treatment plan will be modified (as a proof-of-concept) based on the MRI+FES PTV, and the target dose volume histograms (DVH) will be compared to the MRI-based (gold standard).
- Change in management based on additional information provided in the PET data will be recorded. In an exploratory analysis, FES PET will be compared with standard of care FDG PET/CT or PET/MR for treatment planning.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ER Positive Breast Cancer Patients with Brain Metastases | Experimental | Diagnostic Test: Brain Imaging with 18F-FESA diagnostic intervention where this group will undergo an additional 18F- FES PET/CT scan in addition to their standard of care MRI and FDG PET/CT scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Active diagnosis of ER+ breast cancer (biopsy proven) and new or recurrent brain metastases (biopsy proven or suspected based on MRI appearance)
- Ability to provide informed consent
- Discontinuation of ER modulators for at least 8 weeks, and discontinuation of ER down regulators for at least 28 weeks (as per manufacturer guidelines)
- Age >=18 years
- Eastern Cooperative Oncology Group performance score 0-1
Key exclusion criteria (3 listed)
- Pregnancy
- Unable to undergo Standard of Care
- Allergy to FES.
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 |
|---|---|---|
| Brain Imaging with 18F-FESUsing 18F-FES radiotracer in PET/CT scan to evaluate brain metastases in ER positive breast cancer patients. | Diagnostic test | ER Positive Breast Cancer Patients with Brain Metastases |
Primary outcome
Mean SUV
Time frame: 3 years
Mean standardized uptake value within a region of interest placed based on MRI findings of suspicious brain lesion.
Maximum SUV
Time frame: 3 years
Maximum standardized uptake value within a region of interest placed based on MRI findings of suspicious brain lesion.
SUV Ratio
Time frame: 3 years
Standardized uptake value ratio of target lesion over reference region.
Target-to-Background Ratio
Time frame: 3 years
Qualitative appearance of lesion delineation on PET.
Influx (Ki)
Time frame: 3 years
Parametric PET analysis results within the same region of interest as that for Maximum SUV.
Distribution volume (Vt) for scan times
Time frame: 3 years
Distribution volume (Vt), measured within the same region of interest as that for Maximum SUV, for scan times ranging between 45 min and 85 min with 5min intervals and corresponding results will be compared to those measured with the full dataset at 90mm.
1 secondary outcome
Proportion of cases in which there was a change in management based on FES PET/CT
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Jana Ivanidze, MD/PhD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Brain Imaging with 18F-FES in people with Breast Cancer and Brain Metastases, run by Weill Medical College of Cornell University at 1 site 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 7 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jana Ivanidze, MD/PhD (212-746-4587, jai9018@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean SUV (time frame: 3 years). The study lists 6 primary outcomes in all. 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 29 Oct 2026.