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Lymphoma CancerPhase 1NCT07838649

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

A Phase 1 study testing 68Ga-Galmydar, PET/MRI and 18F-FDG in people with Lymphoma Cancer and Breast Cancer, run by Washington University School of Medicine at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 99 years
What is being tested?
68Ga-Galmydar, PET/MRI and 18F-FDG
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteUnited States
Study dates
1 Nov 2026to 12 Dec 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.)
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Molly Mohrman contact

314-747-4633

mohrmanm@wustl.edu

Pamela Woodard, MD contact

314-362-7100

woodardp@wustl.edu

United States1 site
  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Molly Mohrman, 314-747-4633, mohrmanm@wustl.edu

    Pamela Woodard, MD, 314-362-7100, woodardp@wustl.edu

Other trials in United States

About this study

Official title: 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.

Being tested
68Ga-Galmydar, PET/MRI, 18F-FDG
Keywords
Positron Emission Tomography (PET), Cardiotoxicity, Cardiovascular disease, Chemotherapy-induced cardiac dysfunction, Chemotherapy-induced heart failure, Anthracycline, Doxorubicin, Adriamycin
Medical subject headings
Breast Neoplasms, Lymphoma, Non-Hodgkin, Hodgkin Disease, Cardiotoxicity, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 68Ga-GalmydarDrug

    Also called Ga-Galmydar

    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.

  • PET/MRIDevice

    Also called Positron Emission Tomography/Magnetic Resonance Imaging, PET/MR, PET-MRI

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

  • 18F-FDGDrug

    Also called F-FDG, FDG

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

Study groups in NCT07838649
Study groupRoleWhat they receive
68Ga-Galmydar + PET ImagingExperimentalLymphoma 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
Receives: Drug: 68Ga-Galmydar; Device: PET/MRI; Drug: 18F-FDG

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

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

Secondary outcomes (8)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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

    Measured: 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

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

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

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

    Measured: 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

    Measured: 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completion12 Dec 2029 (estimated)
  4. Study completion12 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07838649
Sponsor's protocol ID
202608159
Other IDs
1R01HL180913-01
Status last verified
Sep 2026
First submitted
17 Sep 2026
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The raw data from the project (MRI, PET, CMP, CBC, Lipid panel, demographic, clinical data, including demographic, along with details on the dose administered) will be preserved and shared. All data will be de-identified prior to receipt by the repository. PET imaging and clinical data will be deposited into Open-Access Series of Imaging Studies (OASIS). Metadata and data dictionary will be shared and made accessible.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 68Ga-Galmydar, PET/MRI and 18F-FDG in people with Lymphoma Cancer and Breast Cancer, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Molly Mohrman (314-747-4633, mohrmanm@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.

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