Clinical trial NCT01807117: PET-MRI in Diagnosing Patients With Colon or Rectal Cancer
Official title: Evaluation of PET-MRI in Initial Staging of High Grade Rectal Cancer Patients and in the Follow up of Colorectal Cancer Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2013-03-08
Enrollment: 15
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
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
timeFrame: Up to 6 months (each scan taking an average of 45 minutes)
measure: Maximum Standardized Uptake Value (SUVmax) in Physiologic Regions and FDG Avid Lesions in Participants Where PET-MRI Was Performed Prior to the PET-CT
timeFrame: Up to 6 months (each scan taking an average of 45 minutes)
measure: SUVmax in Which the PET-CT Was Performed Prior to the PET-MRI.
timeFrame: Up to 6 months (each scan taking an average of 45 minutes)
measure: SUVmax in Which the PET-MRI Was Performed Prior to the PET-CT
timeFrame: Up to 6 months (each scan taking an average of 45 minutes)
measure: SUVmax Ratio in Which the PET-CT Was Performed Prior to the PET-MRI
timeFrame: Up to 6 months (each scan taking an average of 45 minutes)
measure: SUVmax Ratio in Which the PET-MRI Was Performed Prior to the PET-CT
timeFrame: Up to 6 months (each scan taking an average of 45 minutes)
measure: True Positive Rate
timeFrame: Up to 6 months (each scan taking an average of 45 minutes)
measure: True Negative Rate
timeFrame: Up to 6 months (each scan taking an average of 45 minutes)
measure: False Negative Rate
timeFrame: Up to 6 months (each scan taking an average of 45 minutes)
measure: Proportion of Lesions Identified by PET-CT That Were Correctly Detected by PET-MRI
timeFrame: Up to 6 months (each scan taking an average of 45 minutes)
measure: Positive Predictive Values for PET-CT and PET-MRI
timeFrame: Up to 6 months (each scan taking an average of 45 minutes)
measure: Negative Predictive Values for PET-CT and PET-MRI
timeFrame: Up to 6 months (each scan taking an average of 45 minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Comprehensive Cancer Center
name: Raj Paspulati, MD
role: PRINCIPAL_INVESTIGATOR
References: