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Advanced PET/MR Imaging for Breast Cancer

Phase 1 & 2
Recruiting
Led By Anna Sorace, PhD
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
Patients must be ≥ 18 years old and ≤ 75 years old
Patients with HER2+ metastatic breast cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through 5 year follow-up
Awards & highlights

Study Summary

This trial is testing whether new imaging tests can help show if a person with stage IV HER2+ breast cancer is responding to treatment.

Who is the study for?
This trial is for adults aged 18-75 with Stage IV HER2+ breast cancer who haven't started a new HER2-targeted therapy. They must have measurable disease, an expected lifespan over six months, and can be estrogen/progesterone receptor positive or negative. Excluded are those with certain medical conditions, metal in their body incompatible with MRIs, pregnant/breastfeeding women, and anyone unable to lie still for imaging.Check my eligibility
What is being tested?
The study tests whether advanced PET/MR imaging using [18F]-FDG can detect early responses to targeted therapy in patients with advanced-stage HER2+ breast cancer before treatment begins.See study design
What are the potential side effects?
While the trial focuses on imaging rather than drug side effects, potential risks may include reactions to the contrast agent used during MRI (such as gadolinium), discomfort from lying still during the scan, and exposure to radiation from PET/MRI scans.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old.
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I have HER2+ metastatic breast cancer.
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My breast cancer is HER2-positive based on lab tests.
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I have stage IV HER2+ breast cancer and haven't tried the new HER2-targeted treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through 5 year follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 5 year follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Baseline measure of PET standardized uptake value (SUV).
Baseline measure of apparent diffusion coefficient (ADC) in mm2/sec from MRI.
Baseline measure of signal enhancement ratio (SER) from MRI.
+3 more
Secondary outcome measures
Changes in ADC (mm2/sec) from MRI.
Changes in SER from MRI.
Changes in SUV from PET.
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: [18F]-Fluorodeoxyglucose (FDG) PET/ MRIExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,586 Previous Clinical Trials
2,280,212 Total Patients Enrolled
32 Trials studying Breast Cancer
4,491 Patients Enrolled for Breast Cancer
Anna Sorace, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham

Media Library

[18F]-FDG Clinical Trial Eligibility Overview. Trial Name: NCT04273555 — Phase 1 & 2
Breast Cancer Research Study Groups: [18F]-Fluorodeoxyglucose (FDG) PET/ MRI
Breast Cancer Clinical Trial 2023: [18F]-FDG Highlights & Side Effects. Trial Name: NCT04273555 — Phase 1 & 2
[18F]-FDG 2023 Treatment Timeline for Medical Study. Trial Name: NCT04273555 — Phase 1 & 2

Frequently Asked Questions

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

How many people are being asked to participate in this clinical trial?

"That is correct. The clinical trial, which was initially posted on 1/1/2023, is presently looking for 20 participants from 1 site according to information found on clinicaltrials.gov"

Answered by AI

Are we currently enrolling people in this trial?

"This study is currently looking for patients to participate. The details were first posted on January 1st, 2023 and the most recent update was on January 31st, 2022."

Answered by AI

Does this research opportunity extend to seniors?

"According to the study's rules for eligibility, any person aged 18-75 years old can enroll."

Answered by AI

What benefits does this clinical trial hope to bring its participants?

"The main goal of this clinical trial, as measured by SER changes on an MRI from baseline to 6 months, is to compare percent change from imaging visit 2. Additional measures of success, called secondary outcomes, include comparing SUV changes from a PET scan and ADC changes from an MRI at the same time points."

Answered by AI

How can I sign up to participate in this research project?

"This trial is recruiting 20 patients who have the erbb-2 receptor and are between 18 and 75 years old. In addition to meeting this age criteria, participants must also have measurable disease in one metastatic lesion per RECIST v 1.1, be HER2-positive breast cancer prospectively determined on the primary tumor by a local pathology laboratory and defined as immunohistochemistry (IHC) score of 3+ and/or positive by in situ hybridization (ISH) (defined by ISH ratio of ≥ 2.0 for the number of HER2 gene copies to the number of chromosome 17 copies). Only one"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Monitoring Early Response to Targeted Therapy in Stage IV HER2+ Breast Cancer Patients With Advanced PET/MR Imaging
Anna G. Sorace 2025. "Monitoring Early Response to Targeted Therapy in Stage IV HER2+ Breast Cancer Patients With Advanced PET/MR Imaging". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04273555.
~13 spots leftby Jun 2028
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