Quantitation of Left Ventricular Ejection Fraction as Part of F-18 FDG Whole Body PET/CT Scans For Tumor Staging

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Terminated

CT.gov ID

NCT00499382

Collaborator

(none)

Enrollment

Location

53.9

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Primary Objective:

Evaluate the agreement between radionuclide ventriculography (RNV) and gated F-18 fluorodeoxyglucose positron emission tomography/computed tomography (FDG PET/CT) in calculating left ventricular ejection fraction (LVEF), end diastolic volume (EDV) and end systolic volume (ESV).

Condition or Disease	Intervention/Treatment	Phase
Advanced Cancers	Procedure: Nuclear Medicine Cardiac Scan Procedure: PET/CT Cardiac Scan

Detailed Description

Your doctor has ordered a PET/CT scan and a NM scan on you for routine care. By agreeing to take part in this study, you will go through both of these procedures as you normally would.

For both imaging exams, you will be lying on your back. Every effort will be made to make you as comfortable as possible. For theNM cardiac scan, you will be hooked up to a heart monitor that will take a picture every time your heart beats. Your heart will be imaged from several different views. This exam will take about 30 minutes.

The PET/CT cardiac scan will be done after completion of your normally scheduled PET/CT scan. For this scan, you will be hooked to a heart monitor that records the beats of your heart. While this monitor is attached, you will be imaged with the PET/CT scanner. The PET/CT cardiac scan will take about 10-15 minutes after your PET/CT exam is completed.

Both imaging exams will provide a number that corresponds to the percent of blood pushed out of the left ventricle of your heart during a resting state.

Taking part in this study should add between 10-15 additional minutes to your PET/CT visit. This is due to the additional cardiac imaging time.

This is an investigational study. A total of up to 50 patients will take part in this study. All will be enrolled at UTMDACC.

Study Design

Study Type:

Observational

Actual Enrollment :

5 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Quantitation of Left Ventricular Ejection Fraction as Part of F-18 FDG Whole Body PET/CT Scans For Tumor Staging

Study Start Date :

Sep 1, 2004

Actual Primary Completion Date :

Mar 1, 2009

Actual Study Completion Date :

Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
PET/CT scan + NM cardiac scan	Procedure: Nuclear Medicine Cardiac Scan Scan lasting 30 minutes while being hooked up to a heart monitor that takes pictures every time your heart beats. Procedure: PET/CT Cardiac Scan Scan lasting 10-15 minutes and performed after the normally scheduled PET/CT scan.

Arm

Intervention/Treatment

PET/CT scan + NM cardiac scan

Procedure: Nuclear Medicine Cardiac Scan

Scan lasting 30 minutes while being hooked up to a heart monitor that takes pictures every time your heart beats.

Procedure: PET/CT Cardiac Scan

Scan lasting 10-15 minutes and performed after the normally scheduled PET/CT scan.

Outcome Measures

Primary Outcome Measures

To compare the results, called an ejection fraction, of PET/CT and NM cardiac scans of heart. [5 Years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients undergoing both FDG PET/CT scan and RNV within two weeks interval, whether for initial staging, restaging or to evaluate response to therapy.
Patients who would consent to an additional 10-15 minutes acquisition of the gated images after completion of their FDG PET/CT study with the additional radiation exposure.
Patients with regular heart rate.