NCT04883814

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
124

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 12, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

2.9 years

First QC Date

May 7, 2021

Last Update Submit

September 25, 2023

Conditions

Breast Cancer

Keywords

18F-fluoroestradiolBreast CancerPET/CTStaging

Outcome Measures

Primary Outcomes (1)

  • Detection of unsuspected distant metastases

    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

    up to 4 weeks

Secondary Outcomes (1)

  • Detection of suspected disease recurrence

    up to 4 weeks

Study Arms (2)

Initial Staging

EXPERIMENTAL

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

Suspected disease recurrence

EXPERIMENTAL

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

Interventions

18F-fluoroestradiol PET/CTDIAGNOSTIC_TEST

Estrogen receptor targeted imaging

Also known as: FES PET/CT
Initial StagingSuspected disease recurrence

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female ≥ 18 years of age.
  • Histologically confirmed ER-positve breast cancer. Any pathology from a primary or metastatic breast cancer site demonstrating ER-positivity will be allowed.
  • ECOG performance status 0 to 2
  • 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.
  • Either:
  • For cohort 1: Stage 2B-3C locally advanced disease and plan for CT/bone scan systemic staging or
  • For cohort 2: Suspected recurrent disease and plan for CT/bone scan systemic staging

You may not qualify if:

  • Pregnant or breastfeeding
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hoag Memorial Hospital Presbyterian

Irvine, California, 92614, United States

Location

Related Publications (2)

  • Miller R, Battle M, Wangerin K, Huff DT, Weisman AJ, Chen S, Perk TG, Ulaner GA. Evaluating Automated Tools for Lesion Detection on 18F Fluoroestradiol PET/CT Images and Assessment of Concordance with Standard-of-Care Imaging in Metastatic Breast Cancer. Radiol Imaging Cancer. 2025 May;7(3):e240253. doi: 10.1148/rycan.240253.

    PMID: 40314583DERIVED

  • Ulaner GA, Silverstein M, Nangia C, Tetef M, Vandermolen L, Coleman C, Khan S, MacDonald H, Patel T, Techasith T, Mauguen A. ER-Targeted PET for Initial Staging and Suspected Recurrence in ER-Positive Breast Cancer. JAMA Netw Open. 2024 Jul 1;7(7):e2423435. doi: 10.1001/jamanetworkopen.2024.23435.

    PMID: 39058489DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Gary Ulaner, MD, PhD

    Hoag Family Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Molecular Imaging and Therapy

Study Record Dates

First Submitted

May 7, 2021

First Posted

May 12, 2021

Study Start

January 15, 2021

Primary Completion

December 15, 2023

Study Completion

December 15, 2023

Last Updated

September 28, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)