Early Detection of Cardiac Damage With CMR in Women With... | NCT04046315

Studies
Early Detection of Cardiac Damage With CMR in Women With Breast Cancer

NCT04046315

Sponsor

Radboud University Medical Center

Status

Unknown status

Last Update Posted

Mar 16, 2020Actual

Enrollment

55Estimated

Phase

Not provided

Conditions

Cardiotoxicity
Breast Cancer
Chemotherapy Induced Systolic Dysfunction

Interventions

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2020Actual

Primary Completion Date

Mar 31, 2021Estimated

Completion Date

Mar 31, 2021Estimated

First Submitted Date

Aug 1, 2019

First Submission Date that Met QC Criteria

Aug 5, 2019

First Posted Date

Aug 6, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2020

Last Update Posted Date

Mar 16, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

With this study the investigators will assess early cardiac damage by means of Global Longitudinal Strain (GLS) in newly diagnosed breast cancer (BC) patients treated with anthracycline-based chemotherapy, and to investigate whether myocardial damage as measured with T1 / T2 Cardiovascular Magnetic Resonance (CMR) mapping and plasma hs-Troponin T is related to changes in GLS.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

55Estimated

Name	Type	Description	Arm Group Labels	Other Names
CMR	Diagnostic Test	GLS measurement with CMR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Global Longitudinal Strain (GLS) change after chemotherapy compared to baseline	A relative reduction in Global Longitudinal Strain (GLS) assessed with CMR	Baseline and 2 weeks after the last chemotherapy cycle

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female
Age ≥ 18 years
A diagnosis of primary breast cancer
Starting (neo-) adjuvant chemotherapy treatment within 2 months after screening
Cardiotoxicity risk score of intermediate, high or very high risk

Exclusion Criteria:

Previous radiotherapy or systemic cancer treatment
Cancer metastasis
Life expectancy of less than 6 months
History of myocardial infarction or heart failure
Known contra-indications for CMR
Refusal or inability to provide informed consent

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The study population will be recruited from the general BC population receiving (neo-) adjuvant chemotherapy. Patients with a new diagnosis of malignant neoplasm of the breast, codes C50.0-C50.9, according to the World Health Organization International Classification of Diseases (WHO-ICD) will be eligible for participation.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yvonne Koop, MSc	Contact	+31 24-3616785		Yvonne.Koop@radboudumc.nl

Overall Officials

Name	Affiliation	Role
Saloua El Messaoudi, PhD	Radboud University Medical Center	Study Chair
Angela Maas, PhD	Radboud University Medical Center	Principal Investigator
Robin Nijveldt, PhD

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Radboud University Medical Center	Recruiting	Nijmegen		6500 HB	Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D066126	Cardiotoxicity
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided