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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01807117
Other study ID # CASE8212
Secondary ID NCI-2013-00511
Status Completed
Phase N/A
First received
Last updated
Start date April 2013
Est. completion date March 5, 2014

Study information

Verified date April 2021
Source Case Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date March 5, 2014
Est. primary completion date March 5, 2014
Accepts healthy volunteers No
Gender All
Age group 22 Years and older
Eligibility 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

Study Design


Intervention

Procedure:
positron emission tomography
Undergo fludeoxyglucose F 18 PET-CT and PET-MRI
computed tomography
Undergo fludeoxyglucose F 18 PET-CT and PET-MRI
magnetic resonance imaging
Undergo fludeoxyglucose F 18 PET-CT and PET-MRI
Radiation:
fludeoxyglucose F 18
Undergo fludeoxyglucose F 18 PET-CT and PET-MRI

Locations

Country Name City State
United States University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center Cleveland Ohio

Sponsors (1)

Lead Sponsor Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)] Up to 6 months (each scan taking an average of 45 minutes)
Primary 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)] Up to 6 months (each scan taking an average of 45 minutes)
Primary 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)]
Up to 6 months (each scan taking an average of 45 minutes)
Primary 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)] Up to 6 months (each scan taking an average of 45 minutes)
Primary 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)]
Up to 6 months (each scan taking an average of 45 minutes)
Primary 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)] Up to 6 months (each scan taking an average of 45 minutes)
Primary True Positive Rate True positive rate for both modalities - TP/TP+FN
TP = true positives FN = False negatives
Up to 6 months (each scan taking an average of 45 minutes)
Primary True Negative Rate True negative rate for both modalities - TN/TN+FP
TN = true negatives FP = False positives
Up to 6 months (each scan taking an average of 45 minutes)
Primary False Negative Rate False negative rate for both modalities - FN/FN+TP
FN = False negatives TP = true positives
Up to 6 months (each scan taking an average of 45 minutes)
Primary 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 Up to 6 months (each scan taking an average of 45 minutes)
Primary Positive Predictive Values for PET-CT and PET-MRI Percent of true positive rate of diagnostic accuracy. Up to 6 months (each scan taking an average of 45 minutes)
Primary Negative Predictive Values for PET-CT and PET-MRI Percent of true negative rate of diagnostic accuracy Up to 6 months (each scan taking an average of 45 minutes)
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