PET-MRI in Diagnosing Patients With Colon or Rectal Cancer

Study Overview
=================
Brief 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. New diagnostic imaging procedures, such as PET-MRI, may help find and diagnose rectal cancer or recurrence of colorectal cancer

Detailed Description
-----------------
PRIMARY OBJECTIVES: I. 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: I. To test different attenuation correction MR sequences and novel diagnostic MR sequences. OUTLINE: Patients undergo fludeoxyglucose F 18 PET-CT and PET-MRI.

Official Title
-----------------
Evaluation of PET-MRI in Initial Staging of High Grade Rectal Cancer Patients and in the Follow up of Colorectal Cancer Patients.

Conditions
-----------------
Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IIA Colon Cancer, Stage IIA Rectal Cancer, Stage IIB Colon Cancer, Stage IIB Rectal Cancer, Stage IIC Colon Cancer, Stage IIC Rectal Cancer, Stage IIIA Colon Cancer, Stage IIIA Rectal Cancer, Stage IIIB Colon Cancer, Stage IIIB Rectal Cancer, Stage IIIC Colon Cancer, Stage IIIC Rectal Cancer, Stage IVA Colon Cancer, Stage IVA Rectal Cancer, Stage IVB Colon Cancer, Stage IVB Rectal Cancer

Intervention / Treatment
-----------------
* Procedure: positron emission tomography
* Procedure: computed tomography
* Procedure: magnetic resonance imaging
* Radiation: fludeoxyglucose F 18


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 22 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (PET-CT and PET-MRI)<br>Patients undergo fludeoxyglucose F 18 PET-CT and PET-MRI. | Procedure: positron emission tomography<br>* Undergo fludeoxyglucose F 18 PET-CT and PET-MRI<br>* Other names: tomography, emission computed;Procedure: computed tomography<br>* Undergo fludeoxyglucose F 18 PET-CT and PET-MRI<br>* Other names: tomography, computed;Procedure: magnetic resonance imaging<br>* Undergo fludeoxyglucose F 18 PET-CT and PET-MRI<br>* Other names: nuclear magnetic resonance imaging;Radiation: fludeoxyglucose F 18<br>* Undergo fludeoxyglucose F 18 PET-CT and PET-MRI<br>* Other names: FDG;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) |