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

Advanced Cancers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00499382
• Other study ID #: 2004-0578
• Status: Terminated
• Phase: N/A
• First received: July 10, 2007
• Last updated: July 31, 2012
• Start date: September 2004
• Est. completion date: March 2009

Study information

• Verified date: July 2012
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Advanced Cancers

Intervention

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

Locations

Country	Name	City	State
United States	U.T.M.D. Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the results, called an ejection fraction, of PET/CT and NM cardiac scans of heart.		5 Years	No

External Links

•   UT MD Anderson Cancer Center