Clinical trial · Observational
Cardiac MRI Biomarker Testing (GCC 1618)
Cardiac Magnetic Resonance Imaging and Biomarker Testing for Evaluating Cardiac Injury Resulting From Radiation Therapy in Cancer: A Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Unable to meet accrual goal
Summary
Brief summary (as posted)
This research study can help understand how cardiac changes may occur with radiation therapy to the heart based off measurements obtained through biomarkers and cardiac imaging. Researchers plan to perform cardiac imaging and biomarkers for any cardiac injury. Cardiac magnetic resonance imaging (CMR) provides the ability to quantitatively measure cardiac function and injury. The cardiac biomarkers that will be tested are effective in the diagnosis, risk-stratification, and monitoring of heart failure.
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 |
| Lung Cancer (Non-Small Cell) | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
| Mesothelioma | Malignant Mesothelioma | CURATED_EXACT | 0.92 |
| Thoracic Cancer | Malignant Thoracic Neoplasm | ALIAS | 0.90 |
| Thymic Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Complete Cardiac Magnetic Resonance Imaging (MRI) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Breast Cancer
- description
- Breast cancer patients who are undergoing internal mammary lymph node radiation
- interventionNames
- Other: Complete Cardiac Magnetic Resonance Imaging (MRI)
- label
- Lung Cancer, thymic cancer or mesothelioma
- description
- Non-surgical Stage III non-small cell lung cancer patients undergoing mediastinal nodal irradiation with curative intent using concurrent chemotherapy Any lung cancer, thymic cancer or mesothelioma patient getting either chemoradiation or radiation alone wherein heart gets radiation exposure
- interventionNames
- Other: Complete Cardiac Magnetic Resonance Imaging (MRI)
Primary outcomes (2)
- measure
- Evaluate for evidence of changes in cardiac function measured by cardiac MRI prior to and following external beam radiotherapy who are receiving moderate doses of radiation to the heart.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Breast cancer patients who are undergoing internal mammary lymph node radiation which is the investigators institutional policy for patients with axillary lymph node involvement * Clinical AJCC (AJCC, 7th ed.) II, IIIA or IIIB with non-operable disease or those who refuse surgery who are recommended concurrent chemoradiation. Patients who present with N2 or N3 disease and an undetectable NSCLC primary tumor are eligible. * Any lung cancer, thymic cancer or mesothelioma patient getting either chemoradiation or radiation alone wherein heart gets radiation exposure * Patients who have received systemic treatment (up to 4 cycles of induction chemotherapy, or up to 6 months of targeted therapy) and are rendered candidate for concurrent chemoradiation are also eligible * Patients with recurrent disease overlapping or in close proximity to heart getting hypofractionated or conventionally fractionated proton therapy alone. * Intensity modulated radiotherapy, 3-D conformal radiotherapy, electron radiotherapy, and proton radiotherapy will be permitted. * Patients who develop local or nodal recurrence after surgery and rendered candidate for definitive concurrent chemoradiation are also eligible. * The patient must give protocol-specific consent on an IRB approved consent form prior to completion of protocol specific testing/procedures. * 18 years of age or older. Exclusion Criteria: * Pregnant/breast feeding patients or those not willing to undertake contraception if of child-producing potential while on study * Patients with Stage IV disease * Patients with contraindications to MRI examination (e.g. gadolinium allergies/reactions, metallic implants, incompatible implanted electronic/cardiac devices, over scanner weight tolerance etc.) * Patients with hepatorenal syndrome * Patients with Chronic Kidney Disease defined as eGFR \<30 ml/min * Patients unable to lie supine for 30 minutes for MRI examination * Patients having undergone prior radiation therapy to the chest
References
Publications (0)
Data not yet available