Breast CancerEarly Phase 1NCT05659797
FES BPET-DBT in Newly Diagnosed Breast Cancer
A Early Phase 1 study testing BPET/DBT imaging and 18F-FES in people with Breast Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
Patients with newly diagnosed primary estrogen-receptor (ER) positive breast cancer, with at least one breast lesion that is 1.0 cm in diameter or greater, may be eligible for this study. Patients may participate in this study if they are at least 18 years of age. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- BPET/DBT imaging and 18F-FES
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2023to Jan 2028
- Phase
- Early Phase 1
- 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
- Participants will be ≥ 18 years of age.
- Known ER positive (by immunohistochemistry) breast cancer.
- At least one lesion ≥ 1.0 cm that is seen on standard imaging (e.g. mammogram, ultrasound, MRI, CT, FDG-PET/CT). Only one type of imaging is required to show a lesion.
- Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.
Who cannot join
- Females who are pregnant or breast feeding will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential prior to PET imaging..
- Inability to tolerate imaging procedures in the opinion of an investigator or treating physician.
- Currently taking tamoxifen or raloxifene
- Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hannah Straughn contact
United States1 site, 1 recruiting
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19130
Erin Schubert, 215-753-6569, erin.schubert@pennmedicine.upenn.edu
Hannah Straughn, hannah.straughn@pennmedicine.upenn.edu
About this study
Official title: Pilot Study Evaluating the Uptake of [18F]Fluoroestradiol (FES) BPET/DBT in Primary Breast Cancer to Measure the Localized Extent of Estrogen Receptor Positive Disease
Patients with newly diagnosed primary estrogen-receptor (ER) positive breast cancer, with at least one breast lesion that is 1.0 cm in diameter or greater, may be eligible for this study. Patients may participate in this study if they are at least 18 years of age. Up to 20 evaluable subjects will participate in a single imaging cohort. Study subjects will undergo imaging of the breast with a novel device combining dedicated Breast Positron Emission Tomography (BPET) and Digital Breast Tomosynthesis (DBT) following intravenous injection of [18F]-Fluoroestradiol (FES). This is an observational study; FES-BPET/DBT will not be used to direct treatment decisions. While patients and referring physicians will not be blinded to the FES-BPET/DBT results, treatment decisions are made by the treating physicians based upon standard clinical imaging.
Read the detailed description
The FES-BPET/DBT imaging session will include an injection of approximately 6 mCi (expected range of injected dose is 3-7 mCi) FES. Pilot data will be collected to evaluate image quality of FES-BPET/DBT in primary breast cancer. Size and focality of breast cancer extent as measured by FES-BPET/DBT will be compared to disease extent on standard breast imaging modalities. FES uptake on BPET/DBT, as measured by SUV, will be compared to ER expression by immunohistochemistry (IHC) on biopsy specimens. In addition, all subjects in this study will be recruited to the open ended Penn protocol titled 'Evaluation of Long-Axial Field-of-View Positron Emission Tomography Scanner,' IRB #843546. In those subjects who consent to this proposed study as well as #843546, assessment of disease extent on FES-BPET/DBT will be compared to that on whole body PET. Of note, those subjects who also consent to #843546 will not undergo any additional injected dose of FES radiotracer. This preliminary study seeks to evaluate FES-BPET/DBT as a preoperative imaging assay of ER-positive breast cancer disease extent within the breast.
- Conditions
- Breast Cancer
- Being tested
- BPET/DBT imaging, 18F-FES
- Keywords
- PET, 18F-Fluoroestradiol
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPET/DBT imagingDevice
Imaging of the breast with a novel device combining dedicated Breast Positron Emission Tomography (BPET) and Digital Breast Tomosynthesis (DBT) following intravenous injection of [18F]-Fluoroestradiol (FES).
18F-FESDrug
Also called 18F-fluoroestradiol
Radiolabelled fluoroestradiol for PET imaging
| Study group | Role | What they receive |
|---|---|---|
| FES BPET-DBT | Experimental | FES-BPET/DBT imaging session Receives: Device: BPET/DBT imaging; Drug: 18F-FES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake of FES on BPET
Different types of SUV measurements (e.g. Max, Mean and Peak) may be tested to identify the optimal method for analyses for future studies of FES-BPET/DBT.
Measured: 6 weeks
Image quality
The image quality of the study DBT will be compared to the clinical DBT in terms of image quality
Measured: 6 weeks
Image artifacts
Image artifacts on study DBT will be compared to clinical DBT
Measured: 6 weeks
Parenchymal appearance
The parenchymal appearance of the study DBT will be compared to the clinical DBT
Measured: 6 weeks
Tumor size and extent
The size/extent of tumor on the study DBT will be compared to the clinical DBT
Measured: 6 weeks
Secondary outcomes (1)
Estrogen receptor IHC
Clinical immunohistochemical estrogen receptor (ER) results from biopsy or surgery will be compared to FES PET uptake
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start2 Oct 2023
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (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 Abramson Cancer Center at Penn MedicineThe 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Edmonds, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05659797
- Sponsor's protocol ID
- UPCC 08122
- Other IDs
- 852000
- Status last verified
- Feb 2026
- First submitted
- 5 Dec 2022
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Evaluating the Uptake of [18F]Fluoroestradiol (FES) BPET/DBT in Primary Breast Cancer to Measure the Localized Extent of Estrogen Receptor Positive Disease
- ClinicalTrials.gov ID
- NCT05659797
- Acronym / sponsor ID
- UPCC 08122
- Conditions
- Breast Cancer
- Keywords
- PET, 18F-Fluoroestradiol
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 21 Dec 2022 (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.
Patients with newly diagnosed primary estrogen-receptor (ER) positive breast cancer, with at least one breast lesion that is 1.0 cm in diameter or greater, may be eligible for this study. Patients may participate in this study if they are at least 18 years of age. Up to 20 evaluable subjects will participate in a single imaging cohort. Study subjects will undergo imaging of the breast with a novel device combining dedicated Breast Positron Emission Tomography (BPET) and Digital Breast Tomosynthesis (DBT) following intravenous injection of [18F]-Fluoroestradiol (FES). This is an observational study; FES-BPET/DBT will not be used to direct treatment decisions. While patients and referring physicians will not be blinded to the FES-BPET/DBT results, treatment decisions are made by the treating physicians based upon standard clinical imaging.
Detailed description
The FES-BPET/DBT imaging session will include an injection of approximately 6 mCi (expected range of injected dose is 3-7 mCi) FES. Pilot data will be collected to evaluate image quality of FES-BPET/DBT in primary breast cancer. Size and focality of breast cancer extent as measured by FES-BPET/DBT will be compared to disease extent on standard breast imaging modalities. FES uptake on BPET/DBT, as measured by SUV, will be compared to ER expression by immunohistochemistry (IHC) on biopsy specimens. In addition, all subjects in this study will be recruited to the open ended Penn protocol titled 'Evaluation of Long-Axial Field-of-View Positron Emission Tomography Scanner,' IRB #843546. In those subjects who consent to this proposed study as well as #843546, assessment of disease extent on FES-BPET/DBT will be compared to that on whole body PET. Of note, those subjects who also consent to #843546 will not undergo any additional injected dose of FES radiotracer. This preliminary study seeks to evaluate FES-BPET/DBT as a preoperative imaging assay of ER-positive breast cancer disease extent within the breast.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FES BPET-DBT | Experimental | Device: BPET/DBT imaging, Drug: 18F-FESFES-BPET/DBT imaging session |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants will be ≥ 18 years of age.
- Known ER positive (by immunohistochemistry) breast cancer.
- At least one lesion ≥ 1.0 cm that is seen on standard imaging (e.g. mammogram, ultrasound, MRI, CT, FDG-PET/CT). Only one type of imaging is required to show a lesion.
- Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.
Key exclusion criteria (4 listed)
- Females who are pregnant or breast feeding will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential prior to PET imaging..
- Inability to tolerate imaging procedures in the opinion of an investigator or treating physician.
- Currently taking tamoxifen or raloxifene
- Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study.
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 |
|---|---|---|
| BPET/DBT imagingImaging of the breast with a novel device combining dedicated Breast Positron Emission Tomography (BPET) and Digital Breast Tomosynthesis (DBT) following intravenous injection of [18F]-Fluoroestradiol (FES). | Device | FES BPET-DBT |
| 18F-FESAlso: 18F-fluoroestradiolRadiolabelled fluoroestradiol for PET imaging | Drug | FES BPET-DBT |
Primary outcome
Uptake of FES on BPET
Time frame: 6 weeks
Different types of SUV measurements (e.g. Max, Mean and Peak) may be tested to identify the optimal method for analyses for future studies of FES-BPET/DBT.
Image quality
Time frame: 6 weeks
The image quality of the study DBT will be compared to the clinical DBT in terms of image quality
Image artifacts
Time frame: 6 weeks
Image artifacts on study DBT will be compared to clinical DBT
Parenchymal appearance
Time frame: 6 weeks
The parenchymal appearance of the study DBT will be compared to the clinical DBT
Tumor size and extent
Time frame: 6 weeks
The size/extent of tumor on the study DBT will be compared to the clinical DBT
1 secondary outcome
Estrogen receptor IHC
Time frame: 8 weeks
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 27 Feb 2026.
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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.
Hannah Straughn contact
Christine Edmonds, MD principal investigator
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing BPET/DBT imaging and 18F-FES in people with Breast Cancer, run by Abramson Cancer Center at Penn Medicine 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 4 inclusion and 4 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 27 Feb 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Erin o Schubert (2155736569, erin.schubert@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake of FES on BPET (time frame: 6 weeks). The study lists 5 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 27 Feb 2026.