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18F-FES PET/CT Scan for Brain Metastases from Breast Cancer

Phase 4

Recruiting

Led By Jana Ivanidze, MD/PhD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

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

Must have

Age >=18 years

Active diagnosis of ER+ breast cancer (biopsy proven) and new or recurrent brain metastases (biopsy proven or suspected based on MRI appearance)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study Summary

This trial tests a new imaging scan to help plan radiation treatment for breast cancer that has spread to the brain.

Who is the study for?

This trial is for adults over 18 with ER-positive breast cancer and brain metastases, who are set to receive radiation treatment. Participants must be able to consent, have a life expectancy of at least 6 months, and an ECOG score of 0-1. They should not be allergic to FES, pregnant, or unable to undergo standard care.Check my eligibility

What is being tested?

The study tests the use of an additional brain scan called [18F]-FES PET/CT in patients already receiving MRI and FDG PET/CT scans as part of their routine care before radiation therapy for brain metastases from estrogen-receptor positive breast cancer.See study design

What are the potential side effects?

Since this trial involves imaging procedures rather than drugs, side effects may include discomfort during the scan or reactions related to the contrast agent used (if any), such as mild allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I have ER+ breast cancer with new or suspected brain metastases.

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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Distribution volume (Vt) for scan times

Influx (Ki)

Maximum SUV

+3 more

Secondary outcome measures

Proportion of cases in which there was a change in management based on FES PET/CT

Trial Design

1Treatment groups

Experimental Treatment

Group I: ER Positive Breast Cancer Patients with Brain MetastasesExperimental Treatment1 Intervention

A diagnostic intervention where this group will undergo an additional 18F- FES PET/CT scan in addition to their standard of care MRI and FDG PET/CT scan.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor

1,055 Previous Clinical Trials

1,316,275 Total Patients Enrolled

29 Trials studying Breast Cancer

27,162 Patients Enrolled for Breast Cancer

GE HealthcareIndustry Sponsor

291 Previous Clinical Trials

631,076 Total Patients Enrolled

32 Trials studying Breast Cancer

18,717 Patients Enrolled for Breast Cancer

Jana Ivanidze, MD/PhDPrincipal InvestigatorWeill Medical College of Cornell University

1 Previous Clinical Trials

20 Total Patients Enrolled

Frequently Asked Questions

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

Are there any risks to ER Positive Breast Cancer Patients with Brain Metastases during treatment?

"There is substantial supporting evidence of safety for ER Positive Breast cancer Patients with Brain Metastases, thus receiving a rating of 3."

Answered by AI

Are there vacancies available for prospective participants in this research?

"According to clinicaltrials.gov this trial is not enlisting new patients at the moment, with its last update having been made on October 2nd 2023. Despite this fact, there are still 3551 other trials recruiting participants across the globe."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Brain [18F]-FES PET/CT in Patients With Estrogen-Receptor Positive Breast Cancer

2023. "Brain [18F]-FES PET/CT in Patients With Estrogen-Receptor Positive Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06072807.