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

This study has been terminated.
(Slow accrual; study terminated.)
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00499382
First received: July 10, 2007
Last updated: July 31, 2012
Last verified: July 2012
  Purpose

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 Intervention
Advanced Cancers
Procedure: Nuclear Medicine Cardiac Scan
Procedure: PET/CT Cardiac Scan

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To compare the results, called an ejection fraction, of PET/CT and NM cardiac scans of heart. [ Time Frame: 5 Years ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: September 2004
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Study participants with advanced cancer scheduled to have a positron emission tomography/computed tomography (PET/CT) scan and a nuclear medicine (NM) cardiac scan.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00499382

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Isis W. Gayed, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00499382     History of Changes
Other Study ID Numbers: 2004-0578
Study First Received: July 10, 2007
Last Updated: July 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancers
Cardiac Function
Nuclear Medicine Cardiac Scan
Positron Emission Tomography
Radionuclide Ventriculography
Ventricular Ejection Fraction
PET/CT
RNV

ClinicalTrials.gov processed this record on October 20, 2014