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FES-PET/CT Imaging for Breast Cancer

Phase 2

Recruiting

Led By Matthew Covington, MD

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed ER- invasive lobular carcinoma (at any point) at any site with biopsy-proven or imaging suspected metastatic ILC (n=5)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 60 months from baseline

Awards & highlights

Study Summary

This trial is testing a new way to image ILC, using PET/CT.

Who is the study for?

This trial is for adults with invasive lobular carcinoma of the breast, confirmed within the past 12-16 weeks. Participants must be willing to provide blood samples and have their medical records reviewed. It's not for those who've had certain estrogen treatments recently, are pregnant or breastfeeding, or have severe allergies/autoimmune diseases.Check my eligibility

What is being tested?

[18F]Fluoroestradiol (FES) PET/CT imaging is being tested on patients with invasive lobular carcinoma to see how well it detects cancer spread and monitors treatment response over time.See study design

What are the potential side effects?

Potential side effects may include allergic reactions to the radiopharmaceutical used in FES-PET/CT scans. However, individuals with significant drug allergies or autoimmune conditions may still participate at the investigator's discretion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My cancer is ER- and has spread from the lobular area.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 60 months from baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 60 months from baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 months from baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in staging of patients with newly diagnosed ILC

Positive detection rate of invasive lobular carcinoma (ILC) - COMPLETED AS OF MARCH 2022

Secondary outcome measures

Assess correlation between methylated ctDNA and overall survival

Assess relationship between presence of heterogeneous FES-PET/CT update at baseline and overall survival

Assess whether quantity of methylated ctDNA at baseline (primary study arm, n=40) predicts patient stage at presentation

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: All ParticipantsExperimental Treatment1 Intervention

One session of [18F]FES PET/CT Imaging - COMPLETED Up to three imaging sessions: [18F] FES-PET/CT exam, Optional [18F]FDG PET/CT scan and Optional follow-up [18F] FES-PET/CT exam.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor

1,099 Previous Clinical Trials

1,778,610 Total Patients Enrolled

15 Trials studying Breast Cancer

7,124 Patients Enrolled for Breast Cancer

Matthew Covington, MDPrincipal InvestigatorHuntsman Cancer Institute/ University of Utah

1 Previous Clinical Trials

6 Total Patients Enrolled

Media Library

[18F]Fluoroestradiol (FES) PET/CT Clinical Trial Eligibility Overview. Trial Name: NCT04252859 — Phase 2

Breast Cancer Research Study Groups: All Participants

Breast Cancer Clinical Trial 2023: [18F]Fluoroestradiol (FES) PET/CT Highlights & Side Effects. Trial Name: NCT04252859 — Phase 2

[18F]Fluoroestradiol (FES) PET/CT 2023 Treatment Timeline for Medical Study. Trial Name: NCT04252859 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor currently recruiting participants?

"Affirmative. The details available on clinicaltrials.gov point towards this medical investigation actively recruiting participants, having first been posted on the 11th of December 2020 and most recently updated 14th June 2022. At present, 1 site is seeking to enrol 79 patients in total."

Answered by AI

Is [18F]Fluoroestradiol (FES) PET/CT a safe procedure for human beings?

"After assessing the available information, our team at Power has provisionally scored [18F]Fluoroestradiol (FES) PET/CT's safety as a 2. This is because this Phase 2 trial provides preliminary evidence for its security yet no data on efficacy."

Answered by AI

What is the aggregate count of participants in this clinical trial?

"Affirmative. According to clinicaltrials.gov, recruitment for this medical trial is underway having first been posted on December 11th 2020 and most recently updated on June 14th 2022. 79 patients are needed from one site in order to complete the study's objectives."

Answered by AI

What principal aims is this investigation striving to achieve?

"This clinical trial, set to be concluded by March 2022, is aiming to ascertain the positive detection rate of invasive lobular carcinoma (ILC) as its primary objective. The secondary objectives include evaluating the proportion of ER+ ILC not demonstrating a FES uptake and examining discrepancies between FES-PET/CT results and FDG PET/CT readings for biopsy proven primaries, local nodal regions, or distant metastatic lesions. Lastly, it seeks to calculate the number of ER- ILCs indicating a positive FES uptake with SUV max above 1.5."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

[18F]Fluoroestradiol-PET/CT Imaging of Invasive Lobular Carcinoma

2020. "[18F]Fluoroestradiol-PET/CT Imaging of Invasive Lobular Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04252859.