Quantitation of Left Ventricular Ejection Fraction as Part of F-18 FDG Whole Body PET/CT Scans For Tumor Staging
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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 |
- 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.
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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 participants with advanced cancer scheduled to have a positron emission tomography/computed tomography (PET/CT) scan and a nuclear medicine (NM) cardiac scan.
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| United States, Texas | |
| U.T.M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| 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 |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on June 18, 2013