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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

No Placebo-Only Group

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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