Clinical trial NCT05659797: 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
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Breast Cancer
Keywords: PET
18F-Fluoroestradiol
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

1. Participants will be ≥ 18 years of age.
2. Known ER positive (by immunohistochemistry) breast cancer.
3. 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.
4. 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:

1. 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..
2. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician.
3. Currently taking tamoxifen or raloxifene
4. 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.

Primary outcomes:
measure: Uptake of FES on BPET
timeFrame: 6 weeks
measure: Image quality
timeFrame: 6 weeks
measure: Image artifacts
timeFrame: 6 weeks
measure: Parenchymal appearance
timeFrame: 6 weeks
measure: Tumor size and extent
timeFrame: 6 weeks
Secondary outcomes:
measure: Estrogen receptor IHC
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Christine Edmonds, MD
role: PRINCIPAL_INVESTIGATOR
References: