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

NCT07838649 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 2026081591R01HL180913-01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lymphoma Cancer; Breast Cancer; Cancer of the Breast; Non-Hodgkin Lymphoma; Hodgkin Lymphoma

Keywords

Positron Emission Tomography (PET); Cardiotoxicity; Cardiovascular disease; Chemotherapy-induced cardiac dysfunction; Chemotherapy-induced heart failure; Anthracycline; Doxorubicin; Adriamycin

Outcome Measures

Primary Outcomes (4)

• 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.

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

• 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.

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

• 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.

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

• 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.

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

Secondary Outcomes (8)

• Sensitivity of 68Ga-Galmydar

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

• Specificity of 68Ga-Galmydar

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

• Comparison of segmental 68Ga-Galmydar PET SUV to native T1 values from MR

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

• Comparison of global 68Ga-Galmydar PET SUV to native T1 values from MR

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

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

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

Study Arms (1)

68Ga-Galmydar + PET Imaging

EXPERIMENTAL

Lymphoma patients: baseline prior to the start of chemotherapy treatment, after the patient has had at least 250 mg/m\^2 of anthracycline (after the 5th cycle \& before the 6th cycle of anthracycline in Non-Hodgkin lymphoma or after the 5th cycle (10 treatments) in Hodgkin lymphoma, 1-3 weeks after the 5th cycle of anthracycline), and 12-months (+/- 1 month) post-treatment Breast patients: baseline prior to the start of all chemotherapy treatments, baseline after Paclitaxel and prior to the start of AC (Adriamycin \& Cyclophosphamide) for patients treated with the Keynote-522 regimen, 1-2 weeks after the last dose (4 cycles) of AC, and 12-months (+/- 1 month) post-treatment Echocardiography will be performed at all PET imaging sessions \& at 6- and 9-months post-chemotherapy A subset of 3 breast \& 3 lymphoma patients will undergo 18F-FDG PET/MRI. Patients undergoing 18F-FDG PET/MRI will stay overnight \& will be imaged with 18F-FDG in the morning on day 2 under fasting conditions

Drug: 68Ga-Galmydar; Device: PET/MRI; Drug: 18F-FDG

Interventions

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.

Also known as: Ga-Galmydar

68Ga-Galmydar + PET Imaging

PET/MRI DEVICE

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

Also known as: Positron Emission Tomography/Magnetic Resonance Imaging, PET/MR, PET-MRI

68Ga-Galmydar + PET Imaging

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.

Also known as: F-FDG, FDG

68Ga-Galmydar + PET Imaging

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Breast Neoplasms; Lymphoma, Non-Hodgkin; Hodgkin Disease; Cardiotoxicity; Cardiovascular Diseases

Interventions

((ENB-3-isopropoxy-PIDMP)Ga(III)); Positron-Emission Tomography; Magnetic Resonance Imaging; Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope; Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• Pamela K Woodard, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Molly Mohrman

CONTACT

314-747-4633; mohrmanm@wustl.edu

Pamela Woodard, MD

CONTACT

314-362-7100; woodardp@wustl.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 24, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 12, 2029
• Study Completion (Estimated): December 12, 2029
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The research community will have access to the data 12 months after the award begins, or once it is published or the grant award has been completed - whichever comes first. There is no time limit for expiration of data.

Locations

US (1)