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4FMFES-PET Imaging for Breast Cancer

Phase 2

Recruiting

Led By Eric E Turcotte, MD

Research Sponsored by Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Eligibility Criteria Checklist

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

Must have

Advanced breast cancer patients, i.e. stage 3 or 4 diseases

Any HER2-neu status

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months

Awards & highlights

Study Summary

This trial will focus on exploring the full potential and benefit of 4FMFES-PET in combination with FDG-PET for advanced ER+ breast cancer patients to demonstrate it is an essential tool for cancer management.

Who is the study for?

This trial is for adults diagnosed with advanced breast cancer (stage 3 or 4), regardless of gender. Participants must have at least 10% ER-positive tumor cells and be willing to undergo systemic treatment. Pregnant or nursing individuals, those unable to endure a PET/CT scan for 30 minutes, or on certain anti-ER hormone therapies are excluded.Check my eligibility

What is being tested?

The study tests the effectiveness of a new PET imaging agent called 4FMFES in combination with FDG-PET. It aims to improve diagnosis confidence by comparing it with conventional imaging and correlating results with pathological data and patient outcomes in advanced ER+ breast cancer management.See study design

What are the potential side effects?

While specific side effects are not detailed here, typical risks may include discomfort during the PET/CT scan procedure, potential allergic reactions to tracers used, and exposure to radiation from the imaging process.

Eligibility Criteria

Inclusion Criteria

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

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My breast cancer is at an advanced stage (stage 3 or 4).

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My cancer's HER2 status is known.

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My tumor is at least 10% estrogen receptor positive.

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I can care for myself but may not be able to do heavy physical work.

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I was 18 or older when diagnosed with breast cancer.

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My breast cancer is estrogen receptor positive.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Complementarity analysis of FDG-PET with 4FMFES-PET

Correlation of 4FMFES-PET uptake with histopathological markers, notably ER immunohistochemistry (IHC) score

Correlation of treatment response with reduction of 4FMFES-PET uptake and number of assessable lesions at 6 and 18 months after the initial assessment

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: 4FMFES-PET imaging at 0, 6 and 18 monthsExperimental Treatment1 Intervention

Patients burdened with ER+ advanced breast cancers and recruited in the trial will undergo an experimental 4FMFES-PET imaging within a 4-week interval of a medically-prescribed FDG-PET. The 4FMFES-PET procedure will be repeated at 6 and 18 months following the initial scan.

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Canadian Cancer Society (CCS)OTHER

79 Previous Clinical Trials

37,795 Total Patients Enrolled

8 Trials studying Breast Cancer

631 Patients Enrolled for Breast Cancer

Centre de recherche du Centre hospitalier universitaire de SherbrookeLead Sponsor

60 Previous Clinical Trials

31,051 Total Patients Enrolled

1 Trials studying Breast Cancer

198 Patients Enrolled for Breast Cancer

Université de SherbrookeOTHER

298 Previous Clinical Trials

69,791 Total Patients Enrolled

1 Trials studying Breast Cancer

84 Patients Enrolled for Breast Cancer

Media Library

4FMFES-PET Clinical Trial Eligibility Overview. Trial Name: NCT04824014 — Phase 2

Breast Cancer Research Study Groups: 4FMFES-PET imaging at 0, 6 and 18 months

Breast Cancer Clinical Trial 2023: 4FMFES-PET Highlights & Side Effects. Trial Name: NCT04824014 — Phase 2

4FMFES-PET 2023 Treatment Timeline for Medical Study. Trial Name: NCT04824014 — Phase 2

Frequently Asked Questions

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

Has 4FMFES-PET secured authorization from the FDA?

"The safety of 4FMFES-PET is assessed as a 2, since there are no clinical studies that confirm its efficacy yet but existing data does support the drug's basic level of safety."

Answered by AI

Is there still room to enroll in this clinical experiment?

"Affirmative, the information visible on clinicaltrials.gov demonstrates that this medical research is actively calling for volunteers to participate. Initially released on November 1st 2020 and most recently updated July 18th 2022, it requires 150 individuals from one area to complete the trial."

Answered by AI

What is the cumulative tally of participants in this trial?

"Affirmative. As indicated on clinicaltrials.gov, this medical experiment is currently in search of participants; it was originally posted on 11th November 2020 and the most recent update occurred 18th July 2022. The trial requires 150 individuals from a single research centre to participate."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

4FMFES-PET Imaging of ER+ Advanced Breast Cancers

Dr Éric E Turcotte, MD 2020. "4FMFES-PET Imaging of ER+ Advanced Breast Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04824014.