NCT05659797 FES BPET-DBT in Newly Diagnosed Breast Cancer
| NCT ID | NCT05659797 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Abramson Cancer Center at Penn Medicine |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-10-02 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2023-10-02 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Christine Edmonds, MD
PRINCIPAL INVESTIGATOR
Abramson Cancer Center at Penn Medicine
Frequently Asked Questions
Who can join the NCT05659797 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05659797 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05659797 currently recruiting?
Yes, NCT05659797 is actively recruiting participants. Contact the research team at erin.schubert@pennmedicine.upenn.edu for enrollment information.
Where is the NCT05659797 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT05659797 clinical trial?
NCT05659797 is sponsored by Abramson Cancer Center at Penn Medicine. The principal investigator is Christine Edmonds, MD at Abramson Cancer Center at Penn Medicine. The trial plans to enroll 20 participants.
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