Clinical trial · Interventional
Positron Emission Tomography (PET) Imaging of Chemotherapy-Induced Cardiotoxicity
PET Imaging of Chemotherapy-Induced Cardiotoxicity
NCT07838649CI-TRIAL-00126583not yet recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cancer of the Breast | Malignant Breast Neoplasm | ALIAS | 0.90 |
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Lymphoma Cancer | — | UNRESOLVED | — |
| Non-Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-FDG | Drug | — | UNRESOLVED |
| 68Ga-Galmydar | Drug | — | UNRESOLVED |
| PET/MRI | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-Galmydar + PET Imaging
- description
- 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
- interventionNames
- Drug: 68Ga-Galmydar
- Device: PET/MRI
- Drug: 18F-FDG
Primary outcomes (4)
- measure
- Changes in 68Ga-Galmydar Standardized Uptake Value (SUV) in patients with and without cardiotoxicity
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.