HEARTS Trial for Thoracic Cancers

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Wisconsin, Madison

About this trial

The goal of this clinical trial is to compare a new way of using magnetic resonance-guided adaptive radiation therapy (MRgART) to the standard of care linear accelerator (LINAC) radiation treatment in people with cancer in the thoracic region near the heart.

The main question it aims to answer is whether MRgART affects the heart differently than LINAC.

Participants will:

* Receive radiation therapy * Undergo MRIs and bloodwork * Complete quality of life questionnaires

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 18 years at the time of consent.

Dosimetric eligibility criteria met using endpoints from QUANTEC (>10% of heart receives > 25 Gy) as determined through rapid auto-planning

Stage IIB, IIIA, IIIB, IIIC, or IV non-operable non-small cell lung cancer

Limited stage small cell lung cancer, once daily treatment (excluding twice per day fractionation schemes). Stage I-III N0-2 disease esophageal/esophagogastric cancer

Disqualifiers

Definitive clinical or radiologic evidence of metastatic disease with life expectancy <12 months

Prior thoracic radiotherapy significantly overlapping the heart region

Contraindications to MRI

Severe, active co-morbidity defined as follows: New York Heart Association Functional Classification III/IV are not eligible.

Trial design

Design model

Parallel

Treatments tested in this trial

  • MRgART

    Radiation

    Magnetic Resonance-guided Adaptive Radiation Therapy (MRgART) is a form of MRgRT that incorporates daily adaptive planning, or making a new treatment plan each treatment, and real-time imaging during treatment delivery.

  • LINAC

    Radiation

    Daily 3D x-ray scans will be obtained for radiation delivery to confirm tumor and organ at risk placement.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: MRgART radiation therapyExperimental treatment 1 intervention
Group B: LINAC radiation therapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in left ventricular ejection fraction (LVEF)

Changes are measured between timepoints as determined by cardiac MRI. LVEF is calculated by dividing the left ventricular (LV) stroke volume (the amount of blood pumped out) by the end-diastolic volume (the amount of blood in the left ventricle before contraction) and multiplying by 100.

Time frame
Pre-treatment, 3 months post-treatment, 6 months post-treatment

Secondary outcomes

1

Change in right ventricular function (RVEF)

Changes are measured between timepoints as determined by cardiac MRI. RVEF is calculated by dividing the right ventricular (RV) stroke volume (the amount of blood pumped out) by the end-diastolic volume (the amount of blood in the right ventricle before contraction) and multiplying by 100.

Time frame
Pre-treatment, 3 months, 6 months post-treatment
2

Change in left and right ventricular (LV/RV) volumes

Volumes of LV and RV chamber - each derived from tracing the endocardial borders at end-diastole and end-systole in a cardiac MRI scan.

Time frame
Pre-treatment, 3 months, 6 months post-treatment
3

Change in myocardial strain

Myocardial strain measures how much the heart muscle stretches or contracts during a heartbeat. Strain is measured on cardiac MRI images by tracking myocardial deformation using feature tracking techniques, which analyze changes in myocardial length or orientation between end-diastole and end-systole to calculate strain values.

Time frame
Pre-treatment, 3 months, 6 months post-treatment
4

Change in T1 Mapping

By acquiring a series of images at different inversion times (Modified Look-Locker Inversion recovery sequence), the longitudinal relaxation time of myocardial tissue on a pixel-by-pixel basis to derive the T1 map.

Time frame
Pre-treatment, 3 months, 6 months post-treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Wisconsin, Madison

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator