Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04883814
Recruitment Status : Recruiting
First Posted : May 12, 2021
Last Update Posted : August 24, 2021
Sponsor:
Information provided by (Responsible Party):
Gary Ulaner, Hoag Memorial Hospital Presbyterian

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Diagnostic Test: 18F-fluoroestradiol PET/CT Phase 2

Detailed Description:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 18F-fluoroestradiol (FES) PET/CT Compared To Standard-of-Care Imaging In Patients With Breast Cancer
Actual Study Start Date : January 15, 2021
Estimated Primary Completion Date : December 15, 2022
Estimated Study Completion Date : December 15, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: 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
Diagnostic Test: 18F-fluoroestradiol PET/CT
Estrogen receptor targeted imaging
Other Name: FES PET/CT

Experimental: 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
Diagnostic Test: 18F-fluoroestradiol PET/CT
Estrogen receptor targeted imaging
Other Name: FES PET/CT




Primary Outcome Measures :
  1. Detection of unsuspected distant metastases [ Time Frame: up to 4 weeks ]
    FES PET/CT will be compared against standard of care CT/bone scan for detection of unsuspected distant metastases in patients with ER+ locally advanced disease


Secondary Outcome Measures :
  1. Detection of suspected disease recurrence [ Time Frame: up to 4 weeks ]
    FES PET/CT will be compared against standard of care CT/bone scan for detection of unsuspected distant metastases in patients with ER+ breast cancer and suspected disease recurrence



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  4. Selective ER Modulators (SERMs) such as tamoxifen and Selective ER Degraders (SERDs) such as fulvestrant may reduce detection of ER-positive lesions by FES. Thus, exclusion criteria specify that patients must be withdrawn from Selective ER Modifiers for at least 8 weeks and withdrawn from Selective ER Degraders for for least 24 weeks prior to performance of the FES PET/CT.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04883814


Contacts
Layout table for location contacts
Contact: Beth Thomsen 949-764-4577 clinicalresearch@hoag.org
Contact: Gary Ulaner, MD, PhD 949-577-0252 gary.ulaner@hoag.org

Locations
Layout table for location information
United States, California
Hoag Memorial Hospital Presbyterian Recruiting
Irvine, California, United States, 92614
Contact: Beth Thomsen       beth.thomsen@hoag.org   
Principal Investigator: Gary Ulaner, MD         
Sponsors and Collaborators
Hoag Memorial Hospital Presbyterian
Investigators
Layout table for investigator information
Principal Investigator: Gary Ulaner, MD, PhD Hoag Family Cancer Institute
Layout table for additonal information
Responsible Party: Gary Ulaner, Director Molecular Imaging and Therapy, Hoag Memorial Hospital Presbyterian
ClinicalTrials.gov Identifier: NCT04883814    
Other Study ID Numbers: 182-20-CA
First Posted: May 12, 2021    Key Record Dates
Last Update Posted: August 24, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gary Ulaner, Hoag Memorial Hospital Presbyterian:
18F-fluoroestradiol
Breast Cancer
PET/CT
Staging
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases