Positron Emission Tomography (PET) Imaging of Chemotherapy-Induced Cardiotoxicity
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21-99
SponsorWashington University School of Medicine
About this trial
This study is a single center, phase 1 clinical imaging study designed to assess the role of 68Ga-Galmydar Positron Emission Tomography (PET) imaging for detection of cardiotoxicity in human subjects with breast cancer or lymphoma undergoing treatment with anthracycline for cancer therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men and women, 21-99 years of age and any race
Normal left ventricular function (left ventricular ejection fraction (LVEF) >50%) as determined by echocardiography
HER2 positive or negative breast cancer patients or lymphoma patients
Designated to receive standard of care (SOC) treatment with an anthracycline-containing regimen including combination therapy
Disqualifiers
Inability to receive and sign informed consent
Prior exposure to anthracyclines or other cardiotoxic drug
Contraindications to anthracycline chemotherapy
Patients with history of myocardial infarction
Trial design
Design model
Single group
Treatments tested in this trial
68Ga-Galmydar
Drug68Ga-Galmydar is a positron-emitting radioisotope used prior to PET/MRI imaging. Prior to imaging, patients will receive one single intravenous administration of 2.5 mCi ± 20% (2.0-3.0 mCi) of 68Ga-Galmydar followed by a 10 mL normal saline flush on Imaging Day -1.
PET/MRI
DevicePatients will undergo PET/MRI according to standard of care imaging.
18F-FDG
Drug18F-FDG is administered by an intravenous injection of 10 mCi ± 20% (8-12 mCi) followed by a 10 mL normal saline flush.
Treatment groups
36 Participants
are divided into 1 treatment groupGroup A: 68Ga-Galmydar + PET ImagingExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Changes in 68Ga-Galmydar Standardized Uptake Value (SUV) in patients with and without cardiotoxicity
The ability of 68Ga-Galmydar PET/MRI to detect chemotherapy-induced cardiotoxicity will be determined by measuring changes in PET signal (SUV) over time in patients with and without cardiotoxicity. Classification of whether or not a patient develops cardiotoxicity will be determined by evaluation of the left ventricular ejection fraction (LVEF) on echocardiography. Cardiac SUVmean values between pre- and post-chemotherapy will be obtained from PET scans. SUV quantifies the percent of radiotracer that accumulates in a region compared with if the tracer was distributed throughout the body. Mixed effects regression (MER) will be used to examine decreased uptake in those with cardiotoxicity compared to those without toxicity. The regression coefficient for time-by-group interaction will describe the different time trend of SUV uptake over time between two groups.
Time frame
From baseline imaging through 12 months post treatment imaging (total estimated time 57-58 weeks)2
Correlation between 68Ga-Galmydar PET signal and the 18F-FDG PET signal
The relationship between 68Ga-Galmydar PET signal to 18F-FDG PET signal will be indicated using a Pearson or Spearman coefficient, whichever is appropriate. Spearman's correlation coefficient evaluates the association and the association's direction between two ranked continuous variables. Spearman's correlation coefficient ranges from -1 to 1, with a negative number indicating a negative relationship between variables and a positive number indicating a positive relationship between variables. Values closer to zero indicate a weak relationship. Pearson's correlation coefficient is a measure that evaluates the association between two continuous variables with the assumption that the variables have a linear relationship. Pearson's correlation coefficient ranges from -1 to 1, with a negative number indicating a negative relationship between variables and a positive number indicating a positive relationship between variables. Values closer to zero indicate a weak relationship.
Time frame
From baseline imaging through 12 months post treatment imaging (total estimated time 57-58 weeks)3
Correlation of PET signal and Left Ventricular Ejection Fraction (LVEF) from echocardiography
Echocardiography will be conducted prior to starting chemotherapy, at each of the PET/MR visits, and at 6 and 9-months post-chemotherapy for left ventricular function assessment. LVEF is the percentage of blood in the heart's left ventricle that ejects with each contraction. LVEF is calculated by the following equation: LVEF = (End Diastolic Volume (EDV) - End Systolic Volume (ESV)) / EDV × 100 The relationship between LVEF changes and LV-SUV will be assessed similarly with a Pearson correlation.
Time frame
From baseline imaging through 12 months post treatment imaging (total estimated time 57-58 weeks)4
Correlation of PET signal and Left Ventricular Ejection Fraction (LVEF) from MR
MR will be performed with each PET imaging scan. LVEF is the percentage of blood in the heart's left ventricle that ejects with each contraction. LVEF is calculated by the following equation: LVEF = (End Diastolic Volume (EDV) - End Systolic Volume (ESV)) / EDV × 100 The relationship between LVEF changes and LV-SUV will be assessed similarly with a Pearson correlation.
Time frame
From baseline imaging through 12 months post treatment imaging (total estimated time 57-58 weeks)Secondary outcomes
1
Sensitivity of 68Ga-Galmydar
Sensitivity is calculated as the proportion of true positives divided by the sum of true positives and false negatives. Rate of sensitivity and corresponding 95% confidence interval will be reported.
Time frame
From baseline imaging through 12 months post treatment imaging (total estimated time 57-58 weeks)2
Specificity of 68Ga-Galmydar
Specificity is calculated as the proportion of true negatives divided by the sum of true negatives and false positives. Rate of specificity and corresponding 95% confidence interval will be reported.
Time frame
From baseline imaging through 12 months post treatment imaging (total estimated time 57-58 weeks)3
Comparison of segmental 68Ga-Galmydar PET SUV to native T1 values from MR
The myocardial wall segment analysis will be performed using the American Heart Association (AHA) model.
Time frame
From baseline imaging through 12 months post treatment imaging (total estimated time 57-58 weeks)4
Comparison of global 68Ga-Galmydar PET SUV to native T1 values from MR
Time frame
From baseline imaging through 12 months post treatment imaging (total estimated time 57-58 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Washington University School of Medicine
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov
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