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Imaging Techniques for Chemo-Induced Cognitive Impairment in Breast Cancer

Phase 2

Waitlist Available

Research Sponsored by University of Utah

Eligibility Criteria Checklist

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

Must have

Female patients must be 18 years or older

Patients must have a histologically proven diagnosis of Stage I through IIIC Breast Cancer

Must not have

Evidence of stroke or mass lesion on CT or MRI scan

Current use of certain medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is designed to study cognitive impairment in breast cancer patients treated with chemotherapy. The goal is to use [18F]Flutemetamol, FDG-PET, and MRI to better understand the causes of this cognitive impairment, which effects up to 16-50% of individuals receiving long-term adjuvant chemotherapy.

Who is the study for?

This trial is for breast cancer patients aged 18 or older who have completed chemotherapy within the last 6 to 36 months and are experiencing cognitive issues. It excludes those over 70, with neurological diseases, uncontrolled diabetes, pregnancy, color blindness, severe depression, substance abuse history, claustrophobia preventing imaging procedures, major psychiatric illness history, brain radiation therapy history or certain medication use.

What is being tested?

[18F]Flutemetamol and FDG-PET scans along with MRI are being tested to understand cognitive impairment after chemotherapy in breast cancer patients. The study aims to assess amyloid plaque burden and cerebral glucose metabolism changes related to this condition by comparing patient data against healthy control databases.

What are the potential side effects?

While not explicitly listed in the provided information for this specific trial contextually common side effects of PET scans may include discomfort from lying still during the procedure or a reaction at the injection site. MRIs generally have no side effects but can be uncomfortable due to noise and confinement.

Eligibility Criteria

Inclusion Criteria

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

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I am a woman aged 18 or older.

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I have been diagnosed with Stage I to IIIC Breast Cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My scans show a stroke or tumor.

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I am currently taking prescribed medications.

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I have had radiation therapy to my brain.

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My blood sugar was over 175 mg/dl on the day of my PET scan.

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My depression is moderate to severe according to the BDI test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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: All ParticipantsExperimental Treatment3 Interventions

All enrolled subjects will complete three imaging sessions on separate days that consist of: 1) \[18F\]Flutemetamol-PET/CT, 2) FDG-PET/CT, and 3) MRI. The order of the performance of these studies will be based upon subject and radioisotope availability, but they will all be completed within 2 months of each other.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

[18F]Flutemetamol

2012

Completed Phase 3

~320

[18F]fluoro-2-deoxy-D-glucose (FDG)

2010

Completed Phase 1

~50