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PET-MRI in Diagnosing Patients With Colon or Rectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01807117
Recruitment Status : Recruiting
First Posted : March 8, 2013
Last Update Posted : January 22, 2019
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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.
Actual Study Start Date : April 2013
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


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:
  • 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




Primary Outcome Measures :
  1. Maximum Standardized Uptake Value (SUVmax) with PET-CT [ Time Frame: 2 years ]
    SUVmax is defined as [tissue concentration (MBq/g) x body weight (g)]/[injected dose (MBq/g)]

  2. Maximum Standardized Uptake Value (SUVmax) wtih PET-MRI [ Time Frame: 2 years ]
    SUVmax is defined as [tissue concentration (MBq/g) x body weight (g)]/[injected dose (MBq/g)]

  3. Positive predictive values for PET-CT and PET-MRI [ Time Frame: 2 years ]
    Percent of true positive rate of diagnostic accuracy

  4. Negative predictive values for PET-CT and PET-MRI [ Time Frame: 2 years ]
    Percent of true negative rate of diagnostic accuracy

  5. Accuracy for PET-CT and PET-MRI [ Time Frame: 2 years ]
    Comparison of number of detected lesions by PET-CT and PET-MRI



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01807117


Locations
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United States, Ohio
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
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Principal Investigator: Raj Paspulati, MD Case Comprehensive Cancer Center
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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01807117    
Other Study ID Numbers: CASE8212
NCI-2013-00511 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: March 8, 2013    Key Record Dates
Last Update Posted: January 22, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Rectal Neoplasms
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Colonic Diseases
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action