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NCT Number: NCT07838649

Positron Emission Tomography (PET) Imaging of Chemotherapy-Induced Cardiotoxicity

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.

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Key information

Conditions

Lymphoma Cancer Breast Cancer Breast Diseases Breast Neoplasms Cancer of the Breast Cardiotoxicity Cardiovascular Diseases Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Heart Diseases Hemic and Lymphatic Diseases Hodgkin Disease Hodgkin Lymphoma Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Non-Hodgkin Lymphoma Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Injuries Skin Diseases Skin and Connective Tissue Diseases Wounds and Injuries

Age range

21 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Patients willing to adhere to fasting for 15 hours before 18F-FDG PET imaging studies (if applicable)

Exclusion criteria

  • 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
  • Patients with fasting blood sugar >200 mg/dL or <70 mg/dL and symptomatic
  • Contraindications to MR imaging (ferromagnetic implants, pacemaker, brain aneurysm clips, shrapnel, claustrophobia, etc.)
  • Pregnant or lactating. All female subjects of childbearing potential must have a documented negative pregnancy test (serum or urine hCG) performed within 24 hours immediately prior to the administration of 68Ga-Galmydar or documented post-menopausal defined as the cessation of menses for ≥ 12 months or documentation of having a bilateral oophorectomy and/or hysterectomy.
  • Any condition that in the opinion of the Principal Investigator or designee could increase risk to the participant, limit the participant's ability to tolerate the research procedures or interfere with collection of the data such as:
  • Inability to lie still or unable to tolerate a supine position with arms up over the head or down at sides for up to a 60-minute PET scan due to chronic back/shoulder pain or arthritis as assessed by physical examination and/or medical history

Treatment and study plan

68Ga-Galmydar

Drug

68Ga-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.

Other names: Ga-Galmydar

PET/MRI

Device

Patients will undergo PET/MRI according to standard of care imaging.

Other names: Positron Emission Tomography/Magnetic Resonance Imaging, PET/MR, PET-MRI

18F-FDG

Drug

18F-FDG is administered by an intravenous injection of 10 mCi ± 20% (8-12 mCi) followed by a 10 mL normal saline flush.

Other names: F-FDG, FDG

Primary outcomes

  1. Changes in 68Ga-Galmydar Standardized Uptake Value (SUV) in patients with and without cardiotoxicity

    Time frame: From baseline imaging through 12 months post treatment imaging (total estimated time 57-58 weeks)

    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.

  2. Correlation between 68Ga-Galmydar PET signal and the 18F-FDG PET signal

    Time frame: From baseline imaging through 12 months post treatment imaging (total estimated time 57-58 weeks)

    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.

  3. Correlation of PET signal and Left Ventricular Ejection Fraction (LVEF) from echocardiography

    Time frame: From baseline imaging through 12 months post treatment imaging (total estimated time 57-58 weeks)

    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.

  4. Correlation of PET signal and Left Ventricular Ejection Fraction (LVEF) from MR

    Time frame: From baseline imaging through 12 months post treatment imaging (total estimated time 57-58 weeks)

    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.

Secondary outcomes

  1. Sensitivity of 68Ga-Galmydar

    Time frame: From baseline imaging through 12 months post treatment imaging (total estimated time 57-58 weeks)

    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.

  2. Specificity of 68Ga-Galmydar

    Time frame: From baseline imaging through 12 months post treatment imaging (total estimated time 57-58 weeks)

    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.

  3. Comparison of segmental 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)

    The myocardial wall segment analysis will be performed using the American Heart Association (AHA) model.

  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)

  5. Comparison of segmental 68Ga-Galmydar PET SUV to native T2 values from MR

    Time frame: From baseline imaging through 12 months post treatment imaging (total estimated time 57-58 weeks)

    The myocardial wall segment analysis will be performed using the American Heart Association (AHA) model.

  6. Comparison of global 68Ga-Galmydar PET SUV to native T2 values from MR

    Time frame: From baseline imaging through 12 months post treatment imaging (total estimated time 57-58 weeks)

  7. Comparison of global 68Ga-Galmydar PET SUV to global longitudinal strain from MR

    Time frame: From baseline imaging through 12 months post treatment imaging (total estimated time 57-58 weeks)

  8. Comparison of global 68Ga-Galmydar PET SUV to global circumferential strain from MR

    Time frame: From baseline imaging through 12 months post treatment imaging (total estimated time 57-58 weeks)

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

PET Imaging of Chemotherapy-Induced Cardiotoxicity

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Sep 24, 2026
Registry last updated
Sep 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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