Recurrent Rectal Cancer Clinical Trial
Official title:
Evaluation of PET-MRI in Initial Staging of High Grade Rectal Cancer Patients and in the Follow up of Colorectal Cancer Patients.
Verified date | April 2021 |
Source | Case Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 15 |
Est. completion date | March 5, 2014 |
Est. primary completion date | March 5, 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 22 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
Case Comprehensive Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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)] | Up to 6 months (each scan taking an average of 45 minutes) | |
Primary | 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)] | Up to 6 months (each scan taking an average of 45 minutes) | |
Primary | 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)] |
Up to 6 months (each scan taking an average of 45 minutes) | |
Primary | 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)] | Up to 6 months (each scan taking an average of 45 minutes) | |
Primary | 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)] |
Up to 6 months (each scan taking an average of 45 minutes) | |
Primary | 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)] | Up to 6 months (each scan taking an average of 45 minutes) | |
Primary | True Positive Rate | True positive rate for both modalities - TP/TP+FN
TP = true positives FN = False negatives |
Up to 6 months (each scan taking an average of 45 minutes) | |
Primary | True Negative Rate | True negative rate for both modalities - TN/TN+FP
TN = true negatives FP = False positives |
Up to 6 months (each scan taking an average of 45 minutes) | |
Primary | False Negative Rate | False negative rate for both modalities - FN/FN+TP
FN = False negatives TP = true positives |
Up to 6 months (each scan taking an average of 45 minutes) | |
Primary | 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 | Up to 6 months (each scan taking an average of 45 minutes) | |
Primary | Positive Predictive Values for PET-CT and PET-MRI | Percent of true positive rate of diagnostic accuracy. | Up to 6 months (each scan taking an average of 45 minutes) | |
Primary | Negative Predictive Values for PET-CT and PET-MRI | Percent of true negative rate of diagnostic accuracy | Up to 6 months (each scan taking an average of 45 minutes) |
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