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PET-MRI in Diagnosing Patients With Colon or Rectal Cancer

Primary Purpose

Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IIA Colon Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
positron emission tomography
computed tomography
magnetic resonance imaging
fludeoxyglucose F 18
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Recurrent Colon Cancer

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (PET-CT and PET-MRI)

Arm Description

Patients undergo fludeoxyglucose F 18 PET-CT and PET-MRI.

Outcomes

Primary Outcome Measures

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)]
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)]
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)]
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)]
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)]
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)]
True Positive Rate
True positive rate for both modalities - TP/TP+FN TP = true positives FN = False negatives
True Negative Rate
True negative rate for both modalities - TN/TN+FP TN = true negatives FP = False positives
False Negative Rate
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
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
Percent of true positive rate of diagnostic accuracy.
Negative Predictive Values for PET-CT and PET-MRI
Percent of true negative rate of diagnostic accuracy

Secondary Outcome Measures

Full Information

First Posted
March 6, 2013
Last Updated
April 26, 2021
Sponsor
Case Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01807117
Brief Title
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
April 2013 (Actual)
Primary Completion Date
March 5, 2014 (Actual)
Study Completion Date
March 5, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (PET-CT and PET-MRI)
Arm Type
Experimental
Arm Description
Patients undergo fludeoxyglucose F 18 PET-CT and PET-MRI.
Intervention Type
Procedure
Intervention Name(s)
positron emission tomography
Other Intervention Name(s)
FDG-PET, PET, PET scan, tomography, emission computed
Intervention Description
Undergo fludeoxyglucose F 18 PET-CT and PET-MRI
Intervention Type
Procedure
Intervention Name(s)
computed tomography
Other Intervention Name(s)
tomography, computed
Intervention Description
Undergo fludeoxyglucose F 18 PET-CT and PET-MRI
Intervention Type
Procedure
Intervention Name(s)
magnetic resonance imaging
Other Intervention Name(s)
MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging
Intervention Description
Undergo fludeoxyglucose F 18 PET-CT and PET-MRI
Intervention Type
Radiation
Intervention Name(s)
fludeoxyglucose F 18
Other Intervention Name(s)
18FDG, FDG
Intervention Description
Undergo fludeoxyglucose F 18 PET-CT and PET-MRI
Primary Outcome Measure Information:
Title
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
Description
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)]
Time Frame
Up to 6 months (each scan taking an average of 45 minutes)
Title
Maximum Standardized Uptake Value (SUVmax) in Physiologic Regions and FDG Avid Lesions in Participants Where PET-MRI Was Performed Prior to the PET-CT
Description
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)]
Time Frame
Up to 6 months (each scan taking an average of 45 minutes)
Title
SUVmax in Which the PET-CT Was Performed Prior to the PET-MRI.
Description
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)]
Time Frame
Up to 6 months (each scan taking an average of 45 minutes)
Title
SUVmax in Which the PET-MRI Was Performed Prior to the PET-CT
Description
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)]
Time Frame
Up to 6 months (each scan taking an average of 45 minutes)
Title
SUVmax Ratio in Which the PET-CT Was Performed Prior to the PET-MRI
Description
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)]
Time Frame
Up to 6 months (each scan taking an average of 45 minutes)
Title
SUVmax Ratio in Which the PET-MRI Was Performed Prior to the PET-CT
Description
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)]
Time Frame
Up to 6 months (each scan taking an average of 45 minutes)
Title
True Positive Rate
Description
True positive rate for both modalities - TP/TP+FN TP = true positives FN = False negatives
Time Frame
Up to 6 months (each scan taking an average of 45 minutes)
Title
True Negative Rate
Description
True negative rate for both modalities - TN/TN+FP TN = true negatives FP = False positives
Time Frame
Up to 6 months (each scan taking an average of 45 minutes)
Title
False Negative Rate
Description
False negative rate for both modalities - FN/FN+TP FN = False negatives TP = true positives
Time Frame
Up to 6 months (each scan taking an average of 45 minutes)
Title
Proportion of Lesions Identified by PET-CT That Were Correctly Detected by PET-MRI
Description
On a per-lesion basis, proportion of lesions identified by PET-CT that were correctly detected by PET-MRI
Time Frame
Up to 6 months (each scan taking an average of 45 minutes)
Title
Positive Predictive Values for PET-CT and PET-MRI
Description
Percent of true positive rate of diagnostic accuracy.
Time Frame
Up to 6 months (each scan taking an average of 45 minutes)
Title
Negative Predictive Values for PET-CT and PET-MRI
Description
Percent of true negative rate of diagnostic accuracy
Time Frame
Up to 6 months (each scan taking an average of 45 minutes)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raj Paspulati, MD
Organizational Affiliation
Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States

12. IPD Sharing Statement

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PET-MRI in Diagnosing Patients With Colon or Rectal Cancer

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