PET-MRI in Diagnosing Patients With Colon or Rectal Cancer

Not Applicable

Completed

Conditions: Stage IIB Colon Cancer
Stage IIB Rectal Cancer
Stage IIC Rectal Cancer
Stage IIIA Rectal Cancer
Stage IIIC Rectal Cancer
Recurrent Colon Cancer
Stage IIC Colon Cancer
Stage IIIA Colon Cancer
Stage IVA Rectal Cancer
Stage IVB Colon Cancer

Interventions: Procedure: positron emission tomography
Procedure: computed tomography
Procedure: magnetic resonance imaging
Radiation: fludeoxyglucose F 18

Registration Number: NCT01807117

Lead Sponsor: Case Comprehensive Cancer Center

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 15

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (PET-CT and PET-MRI)	magnetic resonance imaging	Patients undergo fludeoxyglucose F 18 PET-CT and PET-MRI.
Diagnostic (PET-CT and PET-MRI)	positron emission tomography	Patients undergo fludeoxyglucose F 18 PET-CT and PET-MRI.
Diagnostic (PET-CT and PET-MRI)	fludeoxyglucose F 18	Patients undergo fludeoxyglucose F 18 PET-CT and PET-MRI.
Diagnostic (PET-CT and PET-MRI)	computed tomography	Patients undergo fludeoxyglucose F 18 PET-CT and PET-MRI.

Primary Outcome Measures

Name	Time	Method
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	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	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.	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	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	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	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	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	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	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	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	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	Up to 6 months (each scan taking an average of 45 minutes)	Percent of true negative rate of diagnostic accuracy