Viewing Study NCT04803084



Ignite Creation Date: 2024-05-06 @ 3:55 PM
Last Modification Date: 2024-10-26 @ 1:59 PM
Study NCT ID: NCT04803084
Status: SUSPENDED
Last Update Posted: 2023-12-12
First Post: 2021-03-12

Brief Title: Multiparametric MRI as a Non-Invasive Biomarker of the Tumor Microenviroment
Sponsor: Laura Kennedy
Organization: Vanderbilt-Ingram Cancer Center

Study Overview

Official Title: Multiparametric MRI as a Non-Invasive Biomarker of the Tumor Microenviroment in Breast Cancer
Status: SUSPENDED
Status Verified Date: 2023-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: MRI upgrade
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This study is looking at how an imaging test could help doctors understand if a patient with early breast cancer will respond to drugs that use the patients immune system to fight cancer
Detailed Description: Primary Objective

- To evaluate serial multiparametric MRI as an early marker for tumor immune response to an immune checkpoint inhibitor agent

Secondary Objective

To assess the potential of early treatment imaging changes on MRI to discern final tumor treatment response
To assess the prognostic potential of MRI features

Correlative

To correlate MRI features with immunophenotypes ie hot and cold tumors
To evaluate the association of MRI features with other known biomarkers of immune checkpoint inhibitor response

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
P50CA098131 NIH None httpsreporternihgovquickSearchP50CA098131