No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Diagnostic
Participants needed
20 (estimated)
Sponsor
Abramson Cancer Center at Penn Medicine · Other
Who this trial is looking for
This trial is looking for women with newly diagnosed estrogen-receptor positive breast cancer. Participants will have imaging tests done to gather information about their cancer using a special device after receiving a small dose of a radioactive substance.
Are You a Good Fit for This Trial?
Must not be takingTamoxifenRaloxifene
You may be able to join if
I am at least 18 years old.
I have been diagnosed with estrogen-receptor positive breast cancer.
I have at least one breast lesion that is 1 cm or larger on a standard imaging test.
I understand that this study is research and I agree to participate.
You may not be able to join if
I am pregnant or breastfeeding.
I cannot tolerate imaging procedures according to my doctor.
I am currently taking tamoxifen or raloxifene.
I have a medical condition that may affect my safety or participation.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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.
Trial Locations
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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. …
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.
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