Study on [18F]Fluoroestradiol-PET/CT Imaging for Invasive Lobular Breast Cancer
Sponsor: University of Utah
ClinicalTrials ID:NCT04252859
This clinical trial is exploring the use of a special imaging technique called FES-PET/CT to better detect and evaluate invasive lobular carcinoma, a type of breast cancer. The study aims to see if this method is more effective than current imaging techniques.
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Program Overview
The purpose of this study is to investigate whether FES-PET/CT imaging can improve the detection and evaluation of invasive lobular carcinoma (ILC), a subtype of breast cancer. Current imaging methods like FDG-PET/CT may not be as effective for ILC compared to other types of breast cancer. This study will focus on how well FES-PET/CT works specifically for ILC, which often shows higher rates of estrogen receptor positivity. The study will compare FES-PET/CT with FDG-PET/CT to see which is better at identifying cancer spread in patients with newly diagnosed ILC.
Description
Invasive lobular carcinoma (ILC) is a type of breast cancer that can be difficult to detect with standard imaging techniques. This study is testing a new imaging method called FES-PET/CT to see if it can better identify and evaluate ILC compared to the commonly used FDG-PET/CT.
ILC often does not show up well on traditional scans because it may not absorb the imaging agents as effectively as other types of breast cancer. This can make it harder to detect and treat. FES-PET/CT uses a different imaging agent that may be more effective for ILC, especially since ILC often has higher levels of estrogen receptors.
The study will involve patients with confirmed ILC and will compare the effectiveness of FES-PET/CT with FDG-PET/CT in detecting cancer spread. The goal is to improve imaging strategies for ILC, which could lead to better treatment decisions and outcomes for patients.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 years or older.
- Willing and able to sign a consent form and allow access to medical records.
- Diagnosed with invasive lobular carcinoma within the last 12 weeks, confirmed by biopsy.
- Agree to have medical records reviewed for at least 24 months after joining the study.
For the expansion phase:
- Diagnosed with ER+ invasive lobular carcinoma within the last 16 weeks, or at any time if metastatic disease is present.
- Willing to provide blood samples for analysis.
- Agree to follow-up contact for about 60 months after joining the study.
Exclusion Criteria
- Known allergies to imaging agents used in the study.
- Need for anesthesia during imaging.
- Claustrophobia preventing PET/CT scanning.
- Pregnant or breastfeeding.
- Medically unstable or requiring hospital care at the time of imaging.
- Recent treatment with certain hormone therapies within 5 weeks of the scan.
- Previous surgical removal of the cancer site (except for certain study groups).
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