Colon CancerNCT01557881
Positron Emission Tomography/Magnetic Resonance Imaging in Patients
A study testing magnetic resonance imaging with positron emission tomography scanning in people with Colon Cancer and Head and Neck Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
This clinical trial studies positron emission tomography (PET)/magnetic resonance imaging (MRI) in patients undergoing PET/computed tomography (CT). Diagnostic procedures, such as PET/MRI, may help doctors diagnose cancer or help doctors predict a patient's response to treatment Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colon Cancer, Head and Neck Cancer, Lung Cancer
- What is being tested?
- magnetic resonance imaging with positron emission tomography scanning
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Apr 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Only patients who are referred by their physician to have a clinical PET/CT will be eligible to participate in the study
- we propose to obtain a second PET/MRI on 100 patients after their clinical PET/CT imaging that spans several disease categories and includes the following cancers: lung, colon, melanoma, head/neck and lymphoma
- In addition to oncology patients, we anticipate imaging a subset of non-cancer patients who will also be imaged subsequent to their clinical PET/CT who will be referrals from neurology and cardiology
- All subjects will be at least 18 years old, or if under 18, parents or guardians must give consent
- Subjects must be stable and have experienced no adverse events from previous clinical PET/CT examination
Who cannot join
- Subjects who do not meet the above inclusion criteria
- Subjects unwilling or unable to sign the informed consent form
- Subjects who are cognitively impaired and thus unable to give informed consent
- Subjects unable to undergo MRI scanning due to exclusion via University Hospital Case Medical Center (UHCMC) MRI restrictions (e.g. implanted metallic or electronic devices, hip or other joint replacements, history of kidney disease, unacceptable creatinine or glomerular filtration rate [GFR], etc)
- Patients who are pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
About this study
Official title: Evaluating Attenuation Correction Methods Applied to PET/MRI
This clinical trial studies positron emission tomography (PET)/magnetic resonance imaging (MRI) in patients undergoing PET/computed tomography (CT). Diagnostic procedures, such as PET/MRI, may help doctors diagnose cancer or help doctors predict a patient's response to treatment
Read the detailed description
PRIMARY OBJECTIVES:
- To acquire PET/MRI scans of 100 patients which will be compared with PET/CT scans of the same subjects. The PET/CT scans will be used to provide the gold standard for evaluating the image quality and quantitative performance of the PET/MRI scans. After comparison and evaluation of the imaging capabilities and performance of the sequential PET/MRI imaging system for these 100 subjects, a second cohort of hundred consecutive subjects may be necessary and again comparisons made to the current standard of PET imaging, PET/CT. This validation of the attenuation correction methods and quantitative accuracy of the PET/MRI device compared to PET/CT will be a continuous iterative process that will result in optimized performance of the PET/MRI and will be a key step in its becoming available to other clinical research projects both within the Seidman Cancer Center as well as in other institutions.
OUTLINE:
After undergoing standard PET/CT, patients undergo PET/MRI.
- Conditions
- Colon Cancer, Head and Neck Cancer, Lung Cancer, Lymphoma, Malignant Neoplasm, Melanoma
- Being tested
- magnetic resonance imaging with positron emission tomography scanning
- Medical subject headings
- Colonic Neoplasms, Head and Neck Neoplasms, Lung Neoplasms, Lymphoma, Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic resonance imaging with positron emission tomography scanningDevice
Also called FDG-PET, PET, PET scan, tomography, emission computed
University Hospitals Seidman Cancer Center [SCC] will house the Philips Ingenuity TF PET/MR, which is a hybrid scanner that merges magnetic resonance imaging with positron emission tomography scanning. University Hospitals is one of only five hospitals in the world with this technology. The PET/MRI system consists of two imaging scanners used sequentially as in PET/CT. The 3Tesla MRI component provides the high resolution that is necessary for soft tissue contrast and functional information on perfusion, diffusion, or metabolism. PET provides information about cellular metabolism and receptor status.
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (PET/MRI) | Experimental | After undergoing standard PET/CT, patients undergo PET/MRI. Receives: Device: magnetic resonance imaging with positron emission tomography scanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized Uptake Value (SUV) on PET/CT Compared to PET/MRI
SUVs for various normal tissues such as liver, cardiac blood pool, and bone will be used. Selected lesions will be assessed as well. Maximum and mean SUVs will be measured for each imaging device. The SUVs and tumor/background ratios will be measured.
Measured: After PET/MRI
Individual Quality Scores, Comprised of Various Qualities of the Image and Include Contrast, Brightness, Resolution, Etc.
A Likert five point scale will be used. Quality scores will be compared using a Wilcoxon signed rank test.
Measured: After PET/MRI
Comparison of Quality Scores (PET/CT vs PET/MRI), Comprised of Various Qualities of the Image and Include Contrast, Brightness, Resolution, Etc.
A Likert five point scale will be used. Quality scores will be compared using a Wilcoxon signed rank test.
Measured: After PET/MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionApr 2015
- Study completionApr 2015
Why it stopped: Funding unavailable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Peter Faulhaber, Principal investigator, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01557881
- Sponsor's protocol ID
- CASE15Z11
- Other IDs
- NCI-2012-00169
- Status last verified
- Feb 2020
- First submitted
- 16 Mar 2012
- Last updated
- 24 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Attenuation Correction Methods Applied to PET/MRI
- ClinicalTrials.gov ID
- NCT01557881
- Acronym / sponsor ID
- CASE15Z11
- Conditions
- Colon Cancer, Head and Neck Cancer, Lung Cancer, Lymphoma, Malignant Neoplasm, Melanoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding unavailable
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 20 Mar 2012 (estimated)
- Results
- Posted 24 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial studies positron emission tomography (PET)/magnetic resonance imaging (MRI) in patients undergoing PET/computed tomography (CT). Diagnostic procedures, such as PET/MRI, may help doctors diagnose cancer or help doctors predict a patient's response to treatment
Detailed description
PRIMARY OBJECTIVES:
- To acquire PET/MRI scans of 100 patients which will be compared with PET/CT scans of the same subjects. The PET/CT scans will be used to provide the gold standard for evaluating the image quality and quantitative performance of the PET/MRI scans. After comparison and evaluation of the imaging capabilities and performance of the sequential PET/MRI imaging system for these 100 subjects, a second cohort of hundred consecutive subjects may be necessary and again comparisons made to the current standard of PET imaging, PET/CT. This validation of the attenuation correction methods and quantitative accuracy of the PET/MRI device compared to PET/CT will be a continuous iterative process that will result in optimized performance of the PET/MRI and will be a key step in its becoming available to other clinical research projects both within the Seidman Cancer Center as well as in other institutions.
OUTLINE:
After undergoing standard PET/CT, patients undergo PET/MRI.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (PET/MRI) | Experimental | Device: magnetic resonance imaging with positron emission tomography scanningAfter undergoing standard PET/CT, patients undergo PET/MRI. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Only patients who are referred by their physician to have a clinical PET/CT will be eligible to participate in the study
- we propose to obtain a second PET/MRI on 100 patients after their clinical PET/CT imaging that spans several disease categories and includes the following cancers: lung, colon, melanoma, head/neck and lymphoma
- In addition to oncology patients, we anticipate imaging a subset of non-cancer patients who will also be imaged subsequent to their clinical PET/CT who will be referrals from neurology and cardiology
- All subjects will be at least 18 years old, or if under 18, parents or guardians must give consent
- Subjects must be stable and have experienced no adverse events from previous clinical PET/CT examination
Key exclusion criteria (5 listed)
- Subjects who do not meet the above inclusion criteria
- Subjects unwilling or unable to sign the informed consent form
- Subjects who are cognitively impaired and thus unable to give informed consent
- Subjects unable to undergo MRI scanning due to exclusion via University Hospital Case Medical Center (UHCMC) MRI restrictions (e.g. implanted metallic or electronic devices, hip or other joint replacements, history of kidney disease, unacceptable creatinine or glomerular filtration rate [GFR], etc)
- Patients who are pregnant
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 |
|---|---|---|
| magnetic resonance imaging with positron emission tomography scanningAlso: FDG-PET, PET, PET scan, tomography, emission computedUniversity Hospitals Seidman Cancer Center [SCC] will house the Philips Ingenuity TF PET/MR, which is a hybrid scanner that merges magnetic resonance imaging with positron emission tomography scanning. University Hospitals is one of only five hospitals in the world with this technology. The PET/MRI system consists of two imaging scanners used sequentially as in PET/CT. The 3Tesla MRI component provides the high resolution that is necessary for soft tissue contrast and functional information on perfusion, diffusion, or metabolism. PET provides information about cellular metabolism and receptor status. | Device | Diagnostic (PET/MRI) |
Primary outcome
Standardized Uptake Value (SUV) on PET/CT Compared to PET/MRI
Time frame: After PET/MRI
SUVs for various normal tissues such as liver, cardiac blood pool, and bone will be used. Selected lesions will be assessed as well. Maximum and mean SUVs will be measured for each imaging device. The SUVs and tumor/background ratios will be measured.
Individual Quality Scores, Comprised of Various Qualities of the Image and Include Contrast, Brightness, Resolution, Etc.
Time frame: After PET/MRI
A Likert five point scale will be used. Quality scores will be compared using a Wilcoxon signed rank test.
Comparison of Quality Scores (PET/CT vs PET/MRI), Comprised of Various Qualities of the Image and Include Contrast, Brightness, Resolution, Etc.
Time frame: After PET/MRI
A Likert five point scale will be used. Quality scores will be compared using a Wilcoxon signed rank test.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Colon Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
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.
Peter Faulhaber principal investigator
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing magnetic resonance imaging with positron emission tomography scanning in people with Colon Cancer and Head and Neck Cancer, run by Case Comprehensive 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 5 inclusion and 5 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 24 Feb 2020. 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?
Yes. Results are posted in the registry (first posted 24 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Standardized Uptake Value (SUV) on PET/CT Compared to PET/MRI (time frame: After PET/MRI). The study lists 3 primary outcomes in all. 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 24 Feb 2020.