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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up patients with cici will have 2 scans within approximately 3 days. medical record review will continue for approximately 2 years following the last scan to review patient progress.
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am a woman aged 18 or older.
Select...
I have been diagnosed with Stage I to IIIC Breast Cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ patients with cici will have 2 scans within approximately 3 days. medical record review will continue for approximately 2 years following the last scan to review patient progress.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~patients with cici will have 2 scans within approximately 3 days. medical record review will continue for approximately 2 years following the last scan to review patient progress.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Brain
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
Functional Magnetic Resonance Imaging (fMRI)
2010
Completed Phase 4
~520
Find a Location
Who is running the clinical trial?
University of UtahLead Sponsor
1,102 Previous Clinical Trials
1,779,251 Total Patients Enrolled
14 Trials studying Breast Cancer
7,114 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman aged 18 or older.My scans show a stroke or tumor.I am currently taking prescribed medications.I have had radiation therapy to my brain.My blood sugar was over 175 mg/dl on the day of my PET scan.I have been diagnosed with Stage I to IIIC Breast Cancer.I finished my chemotherapy between 6 and 36 months ago.My depression is moderate to severe according to the BDI test.
Research Study Groups:
This trial has the following groups:- Group 1: All Participants
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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?
"Yes, according to clinicaltrials.gov, this medical experiment is currently trying to recruit participants. It was first listed on January 31st 2018 and the details were most recently updated on February 3rd 2022. 15 patients are required for one trial site."
Answered by AI
What is the current enrollment size for this study?
"Affirmative. According to information hosted on clinicaltrials.gov, this medical trial is actively recruiting patients since the first posting date of January 31st 2018; with a most recent edit made on February 3rd 2022. This research project requires 15 participants from 1 site."
Answered by AI
To what extent might [18F]Flutemetamol be harmful to patients?
"With no prior evidence of efficacy, but some data indicating safety, [18F]Flutemetamol was rated a 2 on our team's scale."
Answered by AI
Has [18F]Flutemetamol been subject to any preceding clinical trials?
"Presently, there is one ongoing research program studying [18F]Flutemetamol and no trials in Phase 3. The city of Salt Lake City, Utah has the highest concentration of study sites for this molecule with a single centre running its tests."
Answered by AI
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