Back to resultsFES BPET-DBT in Newly Diagnosed Breast Cancer
Primary Purpose
Breast Cancer
Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
BPET/DBT imaging
18F-FES
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring PET, 18F-Fluoroestradiol
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
- University of PennsylvaniaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FES BPET-DBT
Arm Description
FES-BPET/DBT imaging session
Outcomes
Primary Outcome Measures
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.
Image quality
The image quality of the study DBT will be compared to the clinical DBT in terms of image quality
Image artifacts
Image artifacts on study DBT will be compared to clinical DBT
Parenchymal appearance
The parenchymal appearance of the study DBT will be compared to the clinical DBT
Tumor size and extent
The size/extent of tumor on the study DBT will be compared to the clinical DBT
Secondary Outcome Measures
Estrogen receptor IHC
Clinical immunohistochemical estrogen receptor (ER) results from biopsy or surgery will be compared to FES PET uptake
Full Information
NCT ID
NCT05659797
First Posted
December 5, 2022
Last Updated
October 6, 2023
Sponsor
Abramson Cancer Center at Penn Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05659797
Brief Title
FES BPET-DBT in Newly Diagnosed Breast Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2, 2023 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
PET, 18F-Fluoroestradiol
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FES BPET-DBT
Arm Type
Experimental
Arm Description
FES-BPET/DBT imaging session
Intervention Type
Device
Intervention Name(s)
BPET/DBT imaging
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
18F-FES
Other Intervention Name(s)
18F-fluoroestradiol
Intervention Description
Radiolabelled fluoroestradiol for PET imaging
Primary Outcome Measure Information:
Title
Uptake of FES on BPET
Description
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.
Time Frame
6 weeks
Title
Image quality
Description
The image quality of the study DBT will be compared to the clinical DBT in terms of image quality
Time Frame
6 weeks
Title
Image artifacts
Description
Image artifacts on study DBT will be compared to clinical DBT
Time Frame
6 weeks
Title
Parenchymal appearance
Description
The parenchymal appearance of the study DBT will be compared to the clinical DBT
Time Frame
6 weeks
Title
Tumor size and extent
Description
The size/extent of tumor on the study DBT will be compared to the clinical DBT
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Estrogen receptor IHC
Description
Clinical immunohistochemical estrogen receptor (ER) results from biopsy or surgery will be compared to FES PET uptake
Time Frame
8 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erin o Schubert
Phone
2155736569
Email
erin.schubert@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Hannah Straughn
Email
hannah.straughn@pennmedicine.upenn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Edmonds, MD
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19130
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin Schubert
Phone
215-753-6569
Email
erin.schubert@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Hannah Straughn
Email
hannah.straughn@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Christine Edmonds, MD
12. IPD Sharing Statement
Learn more about this trial
FES BPET-DBT in Newly Diagnosed Breast Cancer
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