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

NCT ID: NCT00499382

Last Updated: 2012-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-09-30

Study Completion Date

2009-03-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Advanced Cancers

Keywords

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Advanced Cancers Cardiac Function Nuclear Medicine Cardiac Scan Positron Emission Tomography Radionuclide Ventriculography Ventricular Ejection Fraction PET/CT RNV

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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PET/CT scan + NM cardiac scan

Nuclear Medicine Cardiac Scan

Intervention Type PROCEDURE

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

PET/CT Cardiac Scan

Intervention Type PROCEDURE

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

Interventions

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Nuclear Medicine Cardiac Scan

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

Intervention Type PROCEDURE

PET/CT Cardiac Scan

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Exclusion Criteria

* Blood glucose level above 200 mg/dL.
* Irregular heart rate.
* An interval of less than 1 day between the FDG PET/CT scan and RNV.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Isis W. Gayed, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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U.T.M.D. Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

UT MD Anderson Cancer Center

Other Identifiers

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2004-0578

Identifier Type: -

Identifier Source: org_study_id