PET-MRI in Diagnosing Patients With Colon or Rectal Cancer

Case Comprehensive Cancer Center (Case CCC)

Status: Completed

Conditions: Stage IIB Colon Cancer; Stage IIIA Colon Cancer; Stage IVB Colon Cancer; Stage IVA Rectal Cancer; Recurrent Colon Cancer; Stage IIC Colon Cancer; Stage IIA Colon Cancer; Stage IIIB Colon Cancer; Stage IIA Rectal Cancer; Stage IIIC Colon Cancer; Stage IIC Rectal Cancer; Stage IIB Rectal Cancer; Stage IIIB Rectal Cancer; Stage IVB Rectal Cancer; Stage IIIC Rectal Cancer; Stage IVA Colon Cancer; Stage IIIA Rectal Cancer; Recurrent Rectal Cancer

Treatments: Procedure: computed tomography; Radiation: fludeoxyglucose F 18; Procedure: positron emission tomography; Procedure: magnetic resonance imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT01807117

CASE8212

NCI-2013-00511 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 22+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Diagnostic (PET-CT and PET-MRI)

Experimental group

Description:

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

Treatment:

Procedure: magnetic resonance imaging

Procedure: positron emission tomography

Radiation: fludeoxyglucose F 18

Procedure: computed tomography