PET-MRI in Diagnosing Patients With Colon or Rectal Cancer

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01807117

Enrollment

Registered

2013-03-08

Start date

2013-04-30

Completion date

2014-03-05

Last updated

2021-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

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.

Interventions

PROCEDUREpositron emission tomography

Undergo fludeoxyglucose F 18 PET-CT and PET-MRI

PROCEDUREcomputed tomography

Undergo fludeoxyglucose F 18 PET-CT and PET-MRI

PROCEDUREmagnetic resonance imaging

Undergo fludeoxyglucose F 18 PET-CT and PET-MRI

RADIATIONfludeoxyglucose F 18

Undergo fludeoxyglucose F 18 PET-CT and PET-MRI

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

22 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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	Up to 6 months (each scan taking an average of 45 minutes)	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 \[tissue concentration (MBq/g) x body weight (g)\]/\[injected dose (MBq/g)\]
Maximum Standardized Uptake Value (SUVmax) in Physiologic Regions and FDG Avid Lesions in Participants Where PET-MRI Was Performed Prior to the PET-CT	Up to 6 months (each scan taking an average of 45 minutes)	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 \[tissue concentration (MBq/g) x body weight (g)\]/\[injected dose (MBq/g)\]
SUVmax in Which the PET-CT Was Performed Prior to the PET-MRI.	Up to 6 months (each scan taking an average of 45 minutes)	SUVmax in FDG avid lesions in which the PET/CT was performed prior to the PET-MRI. SUVmax is defined as \[tissue concentration (MBq/g) x body weight (g)\]/\[injected dose (MBq/g)\]
SUVmax in Which the PET-MRI Was Performed Prior to the PET-CT	Up to 6 months (each scan taking an average of 45 minutes)	SUVmax in FDG avid lesions in which the PET-MRI was performed prior to the PET-CT SUVmax is defined as \[tissue concentration (MBq/g) x body weight (g)\]/\[injected dose (MBq/g)\]
SUVmax Ratio in Which the PET-CT Was Performed Prior to the PET-MRI	Up to 6 months (each scan taking an average of 45 minutes)	SUVmax ratio in FDG avid lesions in which the PET-CT was performed prior to the PET-MRI SUVmax is defined as \[tissue concentration (MBq/g) x body weight (g)\]/\[injected dose (MBq/g)\]
SUVmax Ratio in Which the PET-MRI Was Performed Prior to the PET-CT	Up to 6 months (each scan taking an average of 45 minutes)	SUVmax ratio in FDG avid lesions in which the PET-MRI was performed prior to the PET-CT SUVmax is defined as \[tissue concentration (MBq/g) x body weight (g)\]/\[injected dose (MBq/g)\]
True Positive Rate	Up to 6 months (each scan taking an average of 45 minutes)	True positive rate for both modalities - TP/TP+FN TP = true positives FN = False negatives
True Negative Rate	Up to 6 months (each scan taking an average of 45 minutes)	True negative rate for both modalities - TN/TN+FP TN = true negatives FP = False positives
False Negative Rate	Up to 6 months (each scan taking an average of 45 minutes)	False negative rate for both modalities - FN/FN+TP FN = False negatives TP = true positives
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)	On a per-lesion basis, proportion of lesions identified by PET-CT that were correctly detected by PET-MRI
Positive Predictive Values for PET-CT and PET-MRI	Up to 6 months (each scan taking an average of 45 minutes)	Percent of true positive rate of diagnostic accuracy.
Negative Predictive Values for PET-CT and PET-MRI	Up to 6 months (each scan taking an average of 45 minutes)	Percent of true negative rate of diagnostic accuracy

Countries

United States

Participant flow

Participants by arm

Arm	Count
Diagnostic (PET-CT and PET-MRI) Patients undergo fludeoxyglucose F 18 PET-CT and PET-MRI. 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 fludeoxyglucose F 18: Undergo fludeoxyglucose F 18 PET-CT and PET-MRI	15
Total	15

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Disease diagnosis not a study disease	1
Overall Study	Physician Decision	2

Baseline characteristics

Characteristic	Diagnostic (PET-CT and PET-MRI)
Age, Customized years 20-29	0 Participants
Age, Customized years 30-39	0 Participants
Age, Customized years 40-49	4 Participants
Age, Customized years 50-59	3 Participants
Age, Customized years 60-69	4 Participants
Age, Customized years 70-79	4 Participants
Age, Customized years 80-89	0 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	13 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	1 Participants
Race (NIH/OMB) Black or African American	3 Participants
Race (NIH/OMB) More than one race	8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants
Race (NIH/OMB) White	0 Participants
Region of Enrollment United States	15 participants
Sex: Female, Male Female	3 Participants
Sex: Female, Male Male	12 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	6 / 15
other Total, other adverse events	0 / 15
serious Total, serious adverse events	0 / 15