Advanced CancersNCT00499382
Quantitation of Left Ventricular Ejection Fraction as Part of F-18 FDG Whole Body PET/CT Scans For Tumor Staging
An observational study of Advanced Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Advanced Cancers
- What is being tested?
- Nuclear Medicine Cardiac Scan and PET/CT Cardiac Scan
- Type of treatment
- Surgery or procedure
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Mar 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
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).
Read the 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.
- Conditions
- Advanced Cancers
- Being tested
- Nuclear Medicine Cardiac Scan, PET/CT Cardiac Scan
- Keywords
- Advanced Cancers, Cardiac Function, Nuclear Medicine Cardiac Scan, Positron Emission Tomography, Radionuclide Ventriculography, Ventricular Ejection Fraction, PET/CT, RNV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nuclear Medicine Cardiac ScanProcedure or surgery
Scan lasting 30 minutes while being hooked up to a heart monitor that takes pictures every time your heart beats.
PET/CT Cardiac ScanProcedure or surgery
Scan lasting 10-15 minutes and performed after the normally scheduled PET/CT scan.
| Study group | Role | What they receive |
|---|---|---|
| PET/CT scan + NM cardiac scan | Not described Receives: Procedure: Nuclear Medicine Cardiac Scan; Procedure: PET/CT Cardiac Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the results, called an ejection fraction, of PET/CT and NM cardiac scans of heart.
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2007 (estimated)
- Study startSep 2004
- Primary completionMar 2009
- Study completionMar 2009
Why it stopped: Slow accrual; study terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancersStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isis W. Gayed, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00499382
- Sponsor's protocol ID
- 2004-0578
- Status last verified
- Jul 2012
- First submitted
- 10 Jul 2007
- Last updated
- 1 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitation of Left Ventricular Ejection Fraction as Part of F-18 FDG Whole Body PET/CT Scans For Tumor Staging
- ClinicalTrials.gov ID
- NCT00499382
- Acronym / sponsor ID
- 2004-0578
- Conditions
- Advanced Cancers
- Keywords
- Advanced Cancers, Cardiac Function, Nuclear Medicine Cardiac Scan, Positron Emission Tomography, Radionuclide Ventriculography, Ventricular Ejection Fraction, PET/CT, RNV
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow accrual; study terminated.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Sep 2004
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 11 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET/CT scan + NM cardiac scan | – | Procedure: Nuclear Medicine Cardiac Scan, Procedure: PET/CT Cardiac Scan |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nuclear Medicine Cardiac ScanScan lasting 30 minutes while being hooked up to a heart monitor that takes pictures every time your heart beats. | Procedure or surgery | PET/CT scan + NM cardiac scan |
| PET/CT Cardiac ScanScan lasting 10-15 minutes and performed after the normally scheduled PET/CT scan. | Procedure or surgery | PET/CT scan + NM cardiac scan |
Primary outcome
To compare the results, called an ejection fraction, of PET/CT and NM cardiac scans of heart.
Time frame: 5 Years
Results and safety
The study was stopped early (reason given: Slow accrual; study terminated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2012.
- UT MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isis W. Gayed, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow accrual; study terminated.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the results, called an ejection fraction, of PET/CT and NM cardiac scans of heart. (time frame: 5 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2012.