18F-fluoroestradiol (FES) PET/CT for Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-15

Study Completion Date

2023-12-15

Brief Summary

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The standard of care imaging of breast cancer metastases recommended by the National Comprehensive Cancer Network (NCCN), CT of the chest/abdomen/pelvis and bone scan, may be suboptimal. 18F-fluoroestradiol (FES) is a novel PET tracer designed to detect estrogen receptors, which are often expressed in breast cancers. FES PET/CT may provide improved evaluation of metastases in patients with ER-positive breast cancer.

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Detailed Description

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This will be a phase II clinical trial to assess the clinical value of FES for staging and detection of disease recurrence in patients with ER-positive breast cancer, in direct comparison to the National Comprehensive Cancer Network's (NCCN) recommended standard-of-care using CT of the chest/abdomen/pelvis and bone scan \[2\].

Two cohorts will be evaluated:

1. Patients with advanced local breast cancer that will undergo standard of care imaging (CT + bone scan) to evaluate for unsuspected distant metastases.
2. Patients with suspicion for breast cancer recurrence that will undergo standard of care imaging (CT + bone scan) to evaluate for disease recurrence.

In both cohorts, FES PET/CT will be obtained, and compared with standard of care imaging. Whether on standard of care imaging or the research FES PET/CT, lesions suspicious for unsuspected distant metastases (cohort 1) or the site of disease recurrence (cohort 2) will be selected for biopsy, as is clinically standard of care to confirm disease that would alter patient management. Pathology will be used as the reference standard for confirming malignancy.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Initial Staging

FES PET/CT will be compared to CT/bone scan for detection of unsuspected distant metastases in patients with ER-positive locally advanced breast cancer

Group Type EXPERIMENTAL

18F-fluoroestradiol PET/CT

Intervention Type DIAGNOSTIC_TEST

Estrogen receptor targeted imaging

Suspected disease recurrence

FES PET/CT will be compared to CT/bone scan for detection of unsuspected distant metastases in patients with ER-positive breast cancer and suspected disease recurrence

Group Type EXPERIMENTAL

18F-fluoroestradiol PET/CT

Intervention Type DIAGNOSTIC_TEST

Estrogen receptor targeted imaging

Interventions

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18F-fluoroestradiol PET/CT

Estrogen receptor targeted imaging

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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FES PET/CT

Eligibility Criteria

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Inclusion Criteria

1. Female ≥ 18 years of age.
2. Histologically confirmed ER-positve breast cancer. Any pathology from a primary or metastatic breast cancer site demonstrating ER-positivity will be allowed.
3. ECOG performance status 0 to 2
4. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
5. Either:

1. For cohort 1: Stage 2B-3C locally advanced disease and plan for CT/bone scan systemic staging or
2. For cohort 2: Suspected recurrent disease and plan for CT/bone scan systemic staging

Exclusion Criteria

1. Pregnant or breastfeeding
2. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
3. Patients who cannot undergo PET/CT scanning because of weight limits. PET/CT scanners may not be able to function with patients over 450 pounds.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No