Trial Outcomes & Findings for Cardiac Magnetic Resonance Imaging in Patients With Non-Hodgkin Lymphoma or Hodgkin Lymphoma Receiving Doxorubicin (NCT NCT00577798)

Results Overview

A reduction of 10% in left ventricular ejection fraction (LVEF) between the two cMRI studies was considered a subclinical functional event. New or progressive myocardial delayed enhancement within ≥1 segment was deemed as a subclinical structural event. Global left ventricle (LV) radial, circumferential, and longitudinal strain data for each patient were compared between cMRI-1 and cMRI-2. The study had a fixed endpoint (3 months post-treatment)

Recruitment status

COMPLETED

Target enrollment

10 participants

Primary outcome timeframe

cMRI will be done prior to induction of doxorubicin based chemotherapy and at three months after completion of the doxorubicin based chemotherapy regimen.

Results posted on

2023-11-03

Participant Flow

Patients 18 years and above were eligible if they had a new diagnosis (World Health Organization classification) of Non-Hodgkin's lymphoma (NHL) who planned to undergo doxorubicin-based chemotherapy.

Patients 18 years and above were eligible if they had a new diagnosis (World Health Organization classification) of NHL who planned to undergo doxorubicin-based chemotherapy. Patients were excluded if they had chronic kidney disease grade ≥2, active cardiac disease, or symptoms consistent with congestive heart failure.

Participant milestones

Participant milestones
Measure	Contrast-enhanced Magnetic Resonance Imaging Doxorubicin hydrochloride: Standard therapy for patients undergoing chemotherapy for their non-Hogdkin's lymphoma and Hogdkin's lymphoma Contrast-enhanced magnetic resonance imaging: Cardiac magnetic resonance imaging (cMRI) offers the unique advantage of being able to analyze both function and structure (myocardial changes in the form of both a functional decrease in ejection fraction and structural changes within the myocardium defined as delayed contrast uptake).
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Group n=10 Participants Doxorubicin hydrochloride: Standard therapy for patients undergoing chemotherapy for their non-Hogdkin's lymphoma and Hogdkin's lymphoma Contrast-enhanced magnetic resonance imaging: Cardiac magnetic resonance imaging (cMRI) offers the unique advantage of being able to analyze both function and structure (myocardial changes in the form of both a functional decrease in ejection fraction and structural changes within the myocardium defined as delayed contrast uptake).
Age, Continuous	59 years n=10 Participants
Sex: Female, Male Female	4 Participants n=10 Participants
Sex: Female, Male Male	6 Participants n=10 Participants
Region of Enrollment United States	10 Participants n=10 Participants

PRIMARY outcome

Timeframe: cMRI will be done prior to induction of doxorubicin based chemotherapy and at three months after completion of the doxorubicin based chemotherapy regimen.

Population: Ejection fraction (EF) and delayed gadolinium enhancement from cMRI at baseline and 3 months post-treatment will be determined and tested.

A reduction of 10% in left ventricular ejection fraction (LVEF) between the two cMRI studies was considered a subclinical functional event. New or progressive myocardial delayed enhancement within ≥1 segment was deemed as a subclinical structural event. Global left ventricle (LV) radial, circumferential, and longitudinal strain data for each patient were compared between cMRI-1 and cMRI-2. The study had a fixed endpoint (3 months post-treatment)

Outcome measures

Outcome measures
Measure	Contrast-enhanced Magnetic Resonance Imaging n=10 Participants Doxorubicin hydrochloride: Standard therapy for patients undergoing chemotherapy for their non-Hogdkin's lymphoma and Hogdkin's lymphoma Contrast-enhanced magnetic resonance imaging: Cardiac magnetic resonance imaging (cMRI) offers the unique advantage of being able to analyze both function and structure (myocardial changes in the form of both a functional decrease in ejection fraction and structural changes within the myocardium defined as delayed contrast uptake).
Left Ventricular Ejection Fraction (LVEF) and Global Strain Decrease After Doxorubicin Chemotherapy EF determined from cMRI at baseline and 3 months post-treatment.	5 Participants
Left Ventricular Ejection Fraction (LVEF) and Global Strain Decrease After Doxorubicin Chemotherapy Delayed gadolinium enhancement from cMRI at baseline and 3 months post-treatment.	5 Participants

Adverse Events

Single Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Thomas Porter, MD

University of Nebraska Medical Center

Phone: +1 (402) 559-8150

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place