Monitoring HER2+ Breast Cancer Neoadjuvant Treatment With Advanced PET/MRI
ConditionHER2-positive Breast Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Alabama at Birmingham
About this trial
The purpose of the study is to see if using an investigational drug called \[18F\]FMISO with PET/MRI imaging can help monitor and predict the effect of trastuzumab (Herceptin) on chemotherapy in patients diagnosed with advanced HER2 positive breast cancer. This study is for imaging purposes only and is not a treatment study. The results of this study will not change a patient's clinical treatment plan but it may help physicians and researchers better understand how best to treat patients with breast cancer in the future.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients must be ≥ 18 years old and ≤ 75 years old
HER2+ breast cancer determined on primary tumor by a local pathology laboratory and defined as IHC score 3+ and/or positive by ISH (defined by ISH ratio of ≥ 2.0 for the number of HER2 gene copies to the number of chromosome 17 copies). Only one positive result is required for eligibility
Locally advanced stage II-III HER2+ breast cancer patients eligible for neoadjuvant therapy who are naïve to beginning treatment
Estimated life expectancy of greater than one year
Disqualifiers
Inability to provide informed consent F
Weight over 350 lbs., due to the scanner bore size
Lactating, known or suspected pregnancy. Women with child-bearing potential must a have a negative serum β-hCG pregnancy test within 48 hours or a negative urine β-hCG pregnancy test within 48 hours of each PET imaging study.
Contraindication for MRI study (e.g. non-removable metal implants or certain tattoos)
Trial design
Design model
Parallel
Treatments tested in this trial
[18F]FMISO PET/MRI imaging
Drug\[18F\]FMISO PET/MRI imaging
Treatment groups
25 Participants
are divided into 2 treatment groupsGroup A: Herceptin monotherapy cohortExperimental treatment 1 intervention
Group B: Combination therapy cohortExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Baseline measure of PET standardized uptake value (SUV).
Compare baseline metrics from PET/MRI
Time frame
Baseline2
Baseline measure of apparent diffusion coefficient (ADC) in mm2/sec from MRI.
Compare baseline metrics from PET/MRI
Time frame
Baseline3
Baseline measure of signal enhancement ratio (SER) from MRI.
Compare baseline metrics from PET/MRI
Time frame
Baseline4
Changes in SER from MRI
Compare percent change of SER from imaging visit 3 to the baseline.
Time frame
Baseline through 6 monthsSecondary outcomes
1
Follow-up
Compare changes in imaging metrics to neoadjuvant response (defined as pathological complete response, near-pathological response, residual disease).
Time frame
Baseline through 5 years2
Follow-up
Compare changes in imaging metrics to clinical response (defined as disease free-survival or recurrence).
Time frame
Baseline through 5 years3
Changes in ADC (mm2/sec) from MRI.
Compare percent change from imaging visit 2 to the baseline.
Time frame
Baseline through 2 months4
Changes in SER from MRI.
Compare percent change from imaging visit 2 to the baseline.
Time frame
Baseline through 2 monthsSponsors and contacts
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Source ClinicalTrials.gov