Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT07132918
Status:
RECRUITING
Last Update Posted:
2025-11-26
First Post:
2025-08-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
HEARTS Trial for Thoracic Cancers
Sponsor:
University of Wisconsin, Madison
Organization:
Study Overview
Official Title:
The cARdiac Radiation Therapy Sparing (HEARTS) for Thoracic Cancers
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
This clinical trial, The cARdiac Radiation Therapy Sparing (HEARTS) trial, will compare MR-guided adaptive radiation therapy (MRgART) with substructure sparing to standard of care x-ray based linac RT with whole-heart dose metrics for patients with cancer in the thoracic region based on longitudinal changes in cardiac function using MRI, quality of life, cardiac waveforms, and blood biomarkers.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 5R01HL153720-03 | NIH | None | https://reporter.nih.gov/quic… | View |
| A533300 | OTHER | UW Madison | View | |
| SMPH/HUMAN ONCOLOGY/HUMAN ONCO | OTHER | UW Madison | View | |
| Protocol Version 10/31/2025 | OTHER | UW Madison | View |