PET-MRI in Diagnosing Patients With Colon or Rectal Cancer

NCT ID: NCT01807117

Last Updated: 2021-05-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-03-05

Brief Summary

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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

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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.

Conditions

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic (PET-CT and PET-MRI)

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

Group Type EXPERIMENTAL

positron emission tomography

Intervention Type PROCEDURE

Undergo fludeoxyglucose F 18 PET-CT and PET-MRI

computed tomography

Intervention Type PROCEDURE

Undergo fludeoxyglucose F 18 PET-CT and PET-MRI

magnetic resonance imaging

Intervention Type PROCEDURE

Undergo fludeoxyglucose F 18 PET-CT and PET-MRI

fludeoxyglucose F 18

Intervention Type RADIATION

Undergo fludeoxyglucose F 18 PET-CT and PET-MRI

Interventions

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positron emission tomography

Undergo fludeoxyglucose F 18 PET-CT and PET-MRI

Intervention Type PROCEDURE

computed tomography

Undergo fludeoxyglucose F 18 PET-CT and PET-MRI

Intervention Type PROCEDURE

magnetic resonance imaging

Undergo fludeoxyglucose F 18 PET-CT and PET-MRI

Intervention Type PROCEDURE

fludeoxyglucose F 18

Undergo fludeoxyglucose F 18 PET-CT and PET-MRI

Intervention Type RADIATION

Other Intervention Names

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FDG-PET PET PET scan tomography, emission computed tomography, computed MRI NMR imaging NMRI nuclear magnetic resonance imaging 18FDG FDG

Eligibility Criteria

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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

* 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

Exclusion Criteria

* Refuse to give and/or sign the informed consent
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Case Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raj Paspulati, MD

Role: PRINCIPAL_INVESTIGATOR

Case Comprehensive Cancer Center

Locations

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University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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NCI-2013-00511

Identifier Type: REGISTRY

Identifier Source: secondary_id

CASE8212

Identifier Type: -

Identifier Source: org_study_id

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