Positron Emission Tomography (PET) Imaging of Chemotherapy-Induced Cardiotoxicity
PET Imaging of Chemotherapy-Induced Cardiotoxicity
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 21 Years to 99 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This early-stage study tests whether a PET scan using 68Ga-Galmydar can find heart damage caused by chemotherapy. It is for adults with breast cancer or lymphoma who will receive anthracyclines, a type of cancer drug.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Men and women ages 21–99, of any race.
- Have normal heart pumping strength on a heart ultrasound: more than 50% of blood is pumped out with each beat.
- Have breast cancer, either HER2-positive or HER2-negative, or lymphoma.
- Are scheduled for standard cancer treatment that includes an anthracycline drug, alone or with other drugs.
- Are willing to go without food for 15 hours before an 18F-FDG PET scan, if needed.
Who can't join
- Cannot receive and sign the form agreeing to join the study.
- Have taken anthracyclines or other drugs that can damage the heart.
- Have a medical reason that makes anthracycline treatment unsafe.
- Have had a heart attack.
- Have fasting blood sugar above 200 mg/dL, or below 70 mg/dL with symptoms.
- Cannot safely have an MRI scan, for example because of certain metal implants, a pacemaker, brain aneurysm clips, shrapnel, or fear of tight spaces.
- Are pregnant or breastfeeding. Women who could become pregnant need a negative pregnancy test within 24 hours before 68Ga-Galmydar. Records may instead show no periods for at least 12 months or surgery to remove both ovaries or the uterus.
- Have a condition the study doctor thinks could raise risk, make study tests hard to tolerate, or affect data collection. This includes being unable to lie still on your back, with arms overhead or at your sides, for a PET scan lasting up to 60 minutes.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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
Study sites (1)
MO
- Washington University School of Medicine · St Louis, MO 63110Molly Mohrman · Study contact · 314-747-4633 · mohrmanm@wustl.eduPamela Woodard, MD · Study contact · 314-362-7100 · woodardp@wustl.eduPamela K Woodard, MD · Principal investigatorVijay Sharma, PhD · Sub-investigatorMore trials in St Louis