Recurrent Colon CancerNCT01807117
PET-MRI in Diagnosing Patients With Colon or Rectal Cancer
A study testing positron emission tomography, computed tomography and magnetic resonance imaging in people with Recurrent Colon Cancer and Recurrent Rectal Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
This pilot clinical trial studies positron emission tomography (PET)-magnetic resonance imaging (MRI) and PET-computed tomography (CT) as diagnostic imaging in patients with colon and/or rectal cancer. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IIA Colon Cancer
- What is being tested?
- positron emission tomography, computed tomography and magnetic resonance imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to 5 Mar 2014
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Either having a T3 (the cancer has grown through the muscularis propria and into the outermost layers of the colon or rectum but not through them) or higher, node positivity or metastatic lesion in the context of rectal cancer or being studied for colorectal cancer follow up, independent of the renal function
- PET-CT should be requested by a referring physician; in the case of having an MR requested as well, it will be reported from the MRI images generated in the PET-MRI
- Stable physical medical conditions to undergo a MRI
- Informed consent must be given and signed prior to study enrollment
Who cannot join
- Refuse to give and/or sign the informed consent
- Subjects who do not meet the above mentioned inclusion criteria
- Subjects who have a pacemaker
- Subjects who have a metallic prostheses either in the pelvis or in the abdomen that will interfere with the MR imaging of that anatomical area
- Subjects who suffer from claustrophobia
- Pregnant women
- Cognitive impairment that affects the subject's ability to give consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
About this study
Official title: Evaluation of PET-MRI in Initial Staging of High Grade Rectal Cancer Patients and in the Follow up of Colorectal Cancer Patients.
This pilot clinical trial studies positron emission tomography (PET)-magnetic resonance imaging (MRI) and PET-computed tomography (CT) as diagnostic imaging in patients with colon and/or rectal cancer. New diagnostic imaging procedures, such as PET-MRI, may help find and diagnose rectal cancer or recurrence of colorectal cancer
Read the detailed description
PRIMARY OBJECTIVES:
- To test the diagnostic performance of PET- MRI in the staging of preoperative high-grade rectal cancer patients, defined by T3 stage or higher or N1 stage or higher or presence of metastasis, that are referred to PET-CT and MRI.
II. To test the diagnostic performance of PET-MRI the follow up of colorectal cancer patients that are referred to PET-CT with or without a diagnostic MRI request by their physicians.
SECONDARY OBJECTIVES:
- To test different attenuation correction MR sequences and novel diagnostic MR sequences.
OUTLINE:
Patients undergo fludeoxyglucose F 18 PET-CT and PET-MRI.
- Conditions
- Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IIA Colon Cancer, Stage IIA Rectal Cancer, Stage IIB Colon Cancer, Stage IIB Rectal Cancer
- Being tested
- positron emission tomography, computed tomography, magnetic resonance imaging, fludeoxyglucose F 18
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
positron emission tomographyProcedure or surgery
Also called FDG-PET, PET, PET scan, tomography, emission computed
Undergo fludeoxyglucose F 18 PET-CT and PET-MRI
computed tomographyProcedure or surgery
Also called tomography, computed
Undergo fludeoxyglucose F 18 PET-CT and PET-MRI
magnetic resonance imagingProcedure or surgery
Also called MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging
Undergo fludeoxyglucose F 18 PET-CT and PET-MRI
fludeoxyglucose F 18Radiation
Also called 18FDG, FDG
Undergo fludeoxyglucose F 18 PET-CT and PET-MRI
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (PET-CT and PET-MRI) | Experimental | Patients undergo fludeoxyglucose F 18 PET-CT and PET-MRI. Receives: Procedure: positron emission tomography; Procedure: computed tomography; Procedure: magnetic resonance imaging; Radiation: fludeoxyglucose F 18 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Standardized Uptake Value (SUVmax) in Physiologic Regions and Fluorodeoxyglucose (FDG) Avid Lesions in Participants Where PET-CT Was Performed Prior to the PET-MRI
SUV max in physiologic regions (blood pool, liver) and FDG avid lesions, in which the PET-CT was performed prior to the PET-MRI. SUVmax is defined as [tissue concentration (MBq/g) x body weight (g)]/[injected dose (MBq/g)]
Measured: Up to 6 months (each scan taking an average of 45 minutes)
Maximum Standardized Uptake Value (SUVmax) in Physiologic Regions and FDG Avid Lesions in Participants Where PET-MRI Was Performed Prior to the PET-CT
SUV max in physiologic regions (blood pool, liver) and FDG avid lesions, in which the PET-MRI was performed prior to the PET-CT. SUVmax is defined as [tissue concentration (MBq/g) x body weight (g)]/[injected dose (MBq/g)]
Measured: Up to 6 months (each scan taking an average of 45 minutes)
SUVmax in Which the PET-CT Was Performed Prior to the PET-MRI.
SUVmax in FDG avid lesions in which the PET/CT was performed prior to the PET-MRI.
SUVmax is defined as [tissue concentration (MBq/g) x body weight (g)]/[injected dose (MBq/g)]
Measured: Up to 6 months (each scan taking an average of 45 minutes)
SUVmax in Which the PET-MRI Was Performed Prior to the PET-CT
SUVmax in FDG avid lesions in which the PET-MRI was performed prior to the PET-CT SUVmax is defined as [tissue concentration (MBq/g) x body weight (g)]/[injected dose (MBq/g)]
Measured: Up to 6 months (each scan taking an average of 45 minutes)
SUVmax Ratio in Which the PET-CT Was Performed Prior to the PET-MRI
SUVmax ratio in FDG avid lesions in which the PET-CT was performed prior to the PET-MRI
SUVmax is defined as [tissue concentration (MBq/g) x body weight (g)]/[injected dose (MBq/g)]
Measured: Up to 6 months (each scan taking an average of 45 minutes)
SUVmax Ratio in Which the PET-MRI Was Performed Prior to the PET-CT
SUVmax ratio in FDG avid lesions in which the PET-MRI was performed prior to the PET-CT SUVmax is defined as [tissue concentration (MBq/g) x body weight (g)]/[injected dose (MBq/g)]
Measured: Up to 6 months (each scan taking an average of 45 minutes)
True Positive Rate
True positive rate for both modalities - TP/TP+FN
TP = true positives FN = False negatives
Measured: Up to 6 months (each scan taking an average of 45 minutes)
True Negative Rate
True negative rate for both modalities - TN/TN+FP
TN = true negatives FP = False positives
Measured: Up to 6 months (each scan taking an average of 45 minutes)
False Negative Rate
False negative rate for both modalities - FN/FN+TP
FN = False negatives TP = true positives
Measured: Up to 6 months (each scan taking an average of 45 minutes)
Proportion of Lesions Identified by PET-CT That Were Correctly Detected by PET-MRI
On a per-lesion basis, proportion of lesions identified by PET-CT that were correctly detected by PET-MRI
Measured: Up to 6 months (each scan taking an average of 45 minutes)
Positive Predictive Values for PET-CT and PET-MRI
Percent of true positive rate of diagnostic accuracy.
Measured: Up to 6 months (each scan taking an average of 45 minutes)
Negative Predictive Values for PET-CT and PET-MRI
Percent of true negative rate of diagnostic accuracy
Measured: Up to 6 months (each scan taking an average of 45 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study startApr 2013
- Primary completion5 Mar 2014
- Study completion5 Mar 2014
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 Recurrent 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raj Paspulati, MD, Principal investigator, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01807117
- Sponsor's protocol ID
- CASE8212
- Other IDs
- NCI-2013-00511
- Status last verified
- Apr 2021
- First submitted
- 6 Mar 2013
- Last updated
- 18 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of PET-MRI in Initial Staging of High Grade Rectal Cancer Patients and in the Follow up of Colorectal Cancer Patients.
- ClinicalTrials.gov ID
- NCT01807117
- Acronym / sponsor ID
- CASE8212
- Conditions
- Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IIA Colon Cancer, Stage IIA Rectal Cancer, Stage IIB Colon Cancer, Stage IIB Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Apr 2013 (actual)
- Primary completion
- 5 Mar 2014 (actual)
- Study completion
- 5 Mar 2014 (actual)
- First posted
- 8 Mar 2013 (estimated)
- Results
- Posted 18 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot clinical trial studies positron emission tomography (PET)-magnetic resonance imaging (MRI) and PET-computed tomography (CT) as diagnostic imaging in patients with colon and/or rectal cancer. New diagnostic imaging procedures, such as PET-MRI, may help find and diagnose rectal cancer or recurrence of colorectal cancer
Detailed description
PRIMARY OBJECTIVES:
- To test the diagnostic performance of PET- MRI in the staging of preoperative high-grade rectal cancer patients, defined by T3 stage or higher or N1 stage or higher or presence of metastasis, that are referred to PET-CT and MRI.
II. To test the diagnostic performance of PET-MRI the follow up of colorectal cancer patients that are referred to PET-CT with or without a diagnostic MRI request by their physicians.
SECONDARY OBJECTIVES:
- To test different attenuation correction MR sequences and novel diagnostic MR sequences.
OUTLINE:
Patients undergo fludeoxyglucose F 18 PET-CT and 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-CT and PET-MRI) | Experimental | Procedure: positron emission tomography, Procedure: computed tomography, Procedure: magnetic resonance imaging, Radiation: fludeoxyglucose F 18Patients undergo fludeoxyglucose F 18 PET-CT and PET-MRI. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Either having a T3 (the cancer has grown through the muscularis propria and into the outermost layers of the colon or rectum but not through them) or higher, node positivity or metastatic lesion in the context of rectal cancer or being studied for colorectal cancer follow up, independent of the renal function
- PET-CT should be requested by a referring physician; in the case of having an MR requested as well, it will be reported from the MRI images generated in the PET-MRI
- Stable physical medical conditions to undergo a MRI
- Informed consent must be given and signed prior to study enrollment
Key exclusion criteria (7 listed)
- Refuse to give and/or sign the informed consent
- Subjects who do not meet the above mentioned inclusion criteria
- Subjects who have a pacemaker
- Subjects who have a metallic prostheses either in the pelvis or in the abdomen that will interfere with the MR imaging of that anatomical area
- Subjects who suffer from claustrophobia
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 |
|---|---|---|
| positron emission tomographyAlso: FDG-PET, PET, PET scan, tomography, emission computedUndergo fludeoxyglucose F 18 PET-CT and PET-MRI | Procedure or surgery | Diagnostic (PET-CT and PET-MRI) |
| computed tomographyAlso: tomography, computedUndergo fludeoxyglucose F 18 PET-CT and PET-MRI | Procedure or surgery | Diagnostic (PET-CT and PET-MRI) |
| magnetic resonance imagingAlso: MRI, NMR imaging, NMRI, nuclear magnetic resonance imagingUndergo fludeoxyglucose F 18 PET-CT and PET-MRI | Procedure or surgery | Diagnostic (PET-CT and PET-MRI) |
| fludeoxyglucose F 18Also: 18FDG, FDGUndergo fludeoxyglucose F 18 PET-CT and PET-MRI | Radiation | Diagnostic (PET-CT and PET-MRI) |
Primary outcome
Maximum Standardized Uptake Value (SUVmax) in Physiologic Regions and Fluorodeoxyglucose (FDG) Avid Lesions in Participants Where PET-CT Was Performed Prior to the PET-MRI
Time frame: Up to 6 months (each scan taking an average of 45 minutes)
SUV max in physiologic regions (blood pool, liver) and FDG avid lesions, in which the PET-CT was performed prior to the PET-MRI. SUVmax is defined as [tissue concentration (MBq/g) x body weight (g)]/[injected dose (MBq/g)]
Maximum Standardized Uptake Value (SUVmax) in Physiologic Regions and FDG Avid Lesions in Participants Where PET-MRI Was Performed Prior to the PET-CT
Time frame: Up to 6 months (each scan taking an average of 45 minutes)
SUV max in physiologic regions (blood pool, liver) and FDG avid lesions, in which the PET-MRI was performed prior to the PET-CT. SUVmax is defined as [tissue concentration (MBq/g) x body weight (g)]/[injected dose (MBq/g)]
SUVmax in Which the PET-CT Was Performed Prior to the PET-MRI.
Time frame: Up to 6 months (each scan taking an average of 45 minutes)
SUVmax in FDG avid lesions in which the PET/CT was performed prior to the PET-MRI. SUVmax is defined as [tissue concentration (MBq/g) x body weight (g)]/[injected dose (MBq/g)]
SUVmax in Which the PET-MRI Was Performed Prior to the PET-CT
Time frame: Up to 6 months (each scan taking an average of 45 minutes)
SUVmax in FDG avid lesions in which the PET-MRI was performed prior to the PET-CT SUVmax is defined as [tissue concentration (MBq/g) x body weight (g)]/[injected dose (MBq/g)]
SUVmax Ratio in Which the PET-CT Was Performed Prior to the PET-MRI
Time frame: Up to 6 months (each scan taking an average of 45 minutes)
SUVmax ratio in FDG avid lesions in which the PET-CT was performed prior to the PET-MRI SUVmax is defined as [tissue concentration (MBq/g) x body weight (g)]/[injected dose (MBq/g)]
SUVmax Ratio in Which the PET-MRI Was Performed Prior to the PET-CT
Time frame: Up to 6 months (each scan taking an average of 45 minutes)
SUVmax ratio in FDG avid lesions in which the PET-MRI was performed prior to the PET-CT SUVmax is defined as [tissue concentration (MBq/g) x body weight (g)]/[injected dose (MBq/g)]
True Positive Rate
Time frame: Up to 6 months (each scan taking an average of 45 minutes)
True positive rate for both modalities - TP/TP+FN TP = true positives FN = False negatives
True Negative Rate
Time frame: Up to 6 months (each scan taking an average of 45 minutes)
True negative rate for both modalities - TN/TN+FP TN = true negatives FP = False positives
False Negative Rate
Time frame: Up to 6 months (each scan taking an average of 45 minutes)
False negative rate for both modalities - FN/FN+TP FN = False negatives TP = true positives
Proportion of Lesions Identified by PET-CT That Were Correctly Detected by PET-MRI
Time frame: Up to 6 months (each scan taking an average of 45 minutes)
On a per-lesion basis, proportion of lesions identified by PET-CT that were correctly detected by PET-MRI
Positive Predictive Values for PET-CT and PET-MRI
Time frame: Up to 6 months (each scan taking an average of 45 minutes)
Percent of true positive rate of diagnostic accuracy.
Negative Predictive Values for PET-CT and PET-MRI
Time frame: Up to 6 months (each scan taking an average of 45 minutes)
Percent of true negative rate of diagnostic accuracy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Raj Paspulati, MD principal investigator
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 positron emission tomography, computed tomography and magnetic resonance imaging in people with Recurrent Colon Cancer and Recurrent Rectal 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 18 May 2021. 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 18 May 2021). 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?
Maximum Standardized Uptake Value (SUVmax) in Physiologic Regions and Fluorodeoxyglucose (FDG) Avid Lesions in Participants Where PET-CT Was Performed Prior to the PET-MRI (time frame: Up to 6 months (each scan taking an average of 45 minutes)). The study lists 12 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 18 May 2021.