PET-MRI in Diagnosing Patients With Colon or Rectal Cancer

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

Study Overview

• Status: Completed
• Conditions: Stage IIA Rectal Cancer; Stage IIB Rectal Cancer; Stage IIC Rectal Cancer; Stage IIIA Rectal Cancer; Stage IIIB Rectal Cancer; Stage IIIC Rectal Cancer; Stage IIIA Colon Cancer; Stage IIIB Colon Cancer; Stage IIIC Colon Cancer; Recurrent Colon Cancer; Recurrent Rectal Cancer; Stage IVA Colon Cancer; Stage IVA Rectal Cancer; Stage IVB Colon Cancer; Stage IVB Rectal Cancer; Stage IIA Colon Cancer; Stage IIB Colon Cancer; Stage IIC Colon Cancer
• Intervention / Treatment: Procedure: positron emission tomography; Procedure: computed tomography; Procedure: magnetic resonance imaging; Radiation: fludeoxyglucose F 18

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106-5065
      • University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Diagnostic (PET-CT and PET-MRI); Patients undergo fludeoxyglucose F 18 PET-CT and PET-MRI.

Procedure: positron emission tomography; Undergo fludeoxyglucose F 18 PET-CT and PET-MRI; Other Names: PET; FDG-PET; PET scan; tomography, emission computed; Procedure: computed tomography; Undergo fludeoxyglucose F 18 PET-CT and PET-MRI; Other Names: tomography, computed; Procedure: magnetic resonance imaging; Undergo fludeoxyglucose F 18 PET-CT and PET-MRI; Other Names: MRI; NMRI; nuclear magnetic resonance imaging; NMR imaging; Radiation: fludeoxyglucose F 18; Undergo fludeoxyglucose F 18 PET-CT and PET-MRI; Other Names: 18FDG; 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)

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Raj Paspulati, MD, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2013
• Primary Completion (Actual): March 5, 2014
• Study Completion (Actual): March 5, 2014

Study Registration Dates

• First Submitted: March 6, 2013
• First Submitted That Met QC Criteria: March 6, 2013
• First Posted (Estimate): March 8, 2013

Study Record Updates

• Last Update Posted (Actual): May 18, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Disease Attributes; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Recurrence; Rectal Neoplasms; Colonic Neoplasms; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Fluorodeoxyglucose F18
• Other Study ID Numbers: CASE8212; NCI-2013-00511 (Registry Identifier: CTRP (Clinical Trial Reporting Program))