PET-MRI in Diagnosing Patients With Colon or Rectal Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Case Comprehensive Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01807117
First received: March 6, 2013
Last updated: May 1, 2014
Last verified: May 2014
  Purpose

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


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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of PET-MRI in Initial Staging of High Grade Rectal Cancer Patients and in the Follow up of Colorectal Cancer Patients.

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Sensitivity for PET-CT and PET-MRI [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Calculated with its 95% confidence interval using the standard formulas according to the criterion standard. Continuous variables will be expressed as mean and standard deviation. Comparisons between continuous variables will be performed by using the Student t test. Comparisons between qualitative variables will be performed by using the chi-square test with the Yates' correction or McNemar's test as appropriate.

  • Specificity for PET-CT and PET-MRI [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Calculated with its 95% confidence interval using the standard formulas according to the criterion standard. Continuous variables will be expressed as mean and standard deviation. Comparisons between continuous variables will be performed by using the Student t test. Comparisons between qualitative variables will be performed by using the chi-square test with the Yates' correction or McNemar's test as appropriate.

  • Positive and negative predictive values for PET-CT and PET-MRI [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Calculated with its 95% confidence interval using the standard formulas according to the criterion standard. Continuous variables will be expressed as mean and standard deviation. Comparisons between continuous variables will be performed by using the Student t test. Comparisons between qualitative variables will be performed by using the chi-square test with the Yates' correction or McNemar's test as appropriate.

  • Accuracy for PET-CT and PET-MRI [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Calculated with its 95% confidence interval using the standard formulas according to the criterion standard. Continuous variables will be expressed as mean and standard deviation. Comparisons between continuous variables will be performed by using the Student t test. Comparisons between qualitative variables will be performed by using the chi-square test with the Yates' correction or McNemar's test as appropriate.


Estimated Enrollment: 20
Study Start Date: April 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • FDG-PET
  • PET
  • PET scan
  • tomography, emission computed
Procedure: computed tomography
Undergo fludeoxyglucose F 18 PET-CT and PET-MRI
Other Name: tomography, computed
Procedure: magnetic resonance imaging
Undergo fludeoxyglucose F 18 PET-CT and PET-MRI
Other Names:
  • MRI
  • NMR imaging
  • NMRI
  • nuclear magnetic resonance imaging
Radiation: fludeoxyglucose F 18
Undergo fludeoxyglucose F 18 PET-CT and PET-MRI
Other Names:
  • 18FDG
  • FDG

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

Ages Eligible for Study:   22 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01807117

Locations
United States, Ohio
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106-5065
Contact: Raj Paspulati    216-844-1542    Raj.Paspulati@UHhospitals.org   
Principal Investigator: Raj Paspulati         
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Raj Paspulati, MD Case Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01807117     History of Changes
Other Study ID Numbers: CASE8212, NCI-2013-00511
Study First Received: March 6, 2013
Last Updated: May 1, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Colonic Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Fluorodeoxyglucose F18
Radiopharmaceuticals
Diagnostic Uses of Chemicals
Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014