PET-MRI in Diagnosing Patients With Colon or Rectal Cancer

Recurrent Rectal Cancer Clinical Trial

Official title:

Evaluation of PET-MRI in Initial Staging of High Grade Rectal Cancer Patients and in the Follow up of Colorectal Cancer Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01807117
• Other study ID #: CASE8212
• Secondary ID: NCI-2013-00511
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Colonic Neoplasms
• Rectal Neoplasms
• 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

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)