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PET Scans for Brain Inflammation in Breast Cancer

Phase 1
Recruiting
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years of age or older
Female gender
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after pre-study visit and before starting chemotherapy
Awards & highlights

Study Summary

This trial will use PET/MRI scans and an investigational radioactive drug to measure inflammation and abnormal protein in the brain before and after chemotherapy in breast cancer patients.

Who is the study for?
This trial is for women over 50 with newly diagnosed, untreated breast cancer who are English speakers and will undergo chemotherapy. They must have a specific genetic marker (high/mixed affinity binder for TSPO ligands) and cannot be claustrophobic or have chronic infections, inflammatory/autoimmune diseases, recent severe illness, brain metastases, low affinity for TSPO ligands based on genotyping, pregnancy/lactation, blood disorders or dementia.Check my eligibility
What is being tested?
The study tests two PET/MRI scans using radioactive drugs [F-18]DPA-714 to measure brain inflammation and [C-11]PiB to detect beta-amyloid proteins linked to Alzheimer's disease. It aims to understand cognitive issues in older adults after chemotherapy by examining neuroinflammation and amyloid deposition as potential causes.See study design
What are the potential side effects?
As the interventions involve PET/MRI scans with investigational radioactive drugs ([F-18]DPA-714 and [C-11]PiB), potential side effects may include discomfort from lying still during the scan and exposure to radiation; however specific side effects of these substances are not detailed.

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 am female.
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My upcoming chemotherapy will include drugs like taxane or anthracycline.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-study visit through completion of neoadjuvant chemotherapy (nact) (usually around 12 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-study visit through completion of neoadjuvant chemotherapy (nact) (usually around 12 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Measure regional brain TSPO levels using [F-18]DPA-714-PET before and after neoadjuvant chemotherapy
Secondary outcome measures
Correlate cognitive testing and self-reporting before and after beginning cancer therapy with the concentration and regional brain distribution of pathologic amyloid deposition measured with the PET tracer [C-11]PiB prior to beginning therapy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Women with stage 1-4 newly diagnosed breast cancerExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,571 Previous Clinical Trials
2,268,991 Total Patients Enrolled
31 Trials studying Breast Cancer
4,471 Patients Enrolled for Breast Cancer

Media Library

Women with stage 1-4 newly diagnosed breast cancer Clinical Trial Eligibility Overview. Trial Name: NCT04364672 — Phase 1
Breast Cancer Research Study Groups: Women with stage 1-4 newly diagnosed breast cancer
Breast Cancer Clinical Trial 2023: Women with stage 1-4 newly diagnosed breast cancer Highlights & Side Effects. Trial Name: NCT04364672 — Phase 1
Women with stage 1-4 newly diagnosed breast cancer 2023 Treatment Timeline for Medical Study. Trial Name: NCT04364672 — Phase 1

Frequently Asked Questions

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

Are there any adverse effects associated with [11C]PiB and 18F-labeled DPA-714 PET scans for patients?

"Based on our analysis, [11C]PiB and 18F-labeled DPA-714 PET scan have been given a rating of 1 as this is an early phase trial. At present, there is limited data available to assess the safety or efficacy of these scans."

Answered by AI

Is recruitment for this research project still underway?

"According to the records from clinicaltrials.gov, this trial is presently open for enrollment and has been since June 1st 2023. It was last edited on 6/7/2022."

Answered by AI

What is the maximum capacity for enrollees in this trial?

"Affirmative. According to clinicaltrials.gov, this research experiment is still looking for participants and was first posted on June 1st 2023 with its last update occurring on July 6th 2022. It requires approximately 20 individuals from one site."

Answered by AI
~13 spots leftby Jul 2026