Trial Outcomes & Findings for PET-MRI in Diagnosing Patients With Colon or Rectal Cancer (NCT NCT01807117)

NCT ID: NCT01807117

Last Updated: 2021-05-18

Results Overview

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 \[tissue concentration (MBq/g) x body weight (g)\]/\[injected dose (MBq/g)\]

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

Up to 6 months (each scan taking an average of 45 minutes)

Results posted on

2021-05-18

Participant Flow

Participant milestones

Participant milestones
Measure
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
Overall Study
STARTED
15
Overall Study
COMPLETED
12
Overall Study
NOT COMPLETED
3

Reasons for withdrawal

Reasons for withdrawal
Measure
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
Overall Study
Physician Decision
2
Overall Study
Disease diagnosis not a study disease
1

Baseline Characteristics

PET-MRI in Diagnosing Patients With Colon or Rectal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Diagnostic (PET-CT and PET-MRI)
n=15 Participants
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
Age, Customized
years · 20-29
0 Participants
n=5 Participants
Age, Customized
years · 30-39
0 Participants
n=5 Participants
Age, Customized
years · 40-49
4 Participants
n=5 Participants
Age, Customized
years · 50-59
3 Participants
n=5 Participants
Age, Customized
years · 60-69
4 Participants
n=5 Participants
Age, Customized
years · 70-79
4 Participants
n=5 Participants
Age, Customized
years · 80-89
0 Participants
n=5 Participants
Sex: Female, Male
Female
3 Participants
n=5 Participants
Sex: Female, Male
Male
12 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
2 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
13 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
1 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
3 Participants
n=5 Participants
Race (NIH/OMB)
White
0 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
8 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants
n=5 Participants
Region of Enrollment
United States
15 participants
n=5 Participants

PRIMARY outcome

Timeframe: Up to 6 months (each scan taking an average of 45 minutes)

Population: Participants who received PET-CT as initial imaging followed by PET-MRI. Evaluable lesions for this group.

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 \[tissue concentration (MBq/g) x body weight (g)\]/\[injected dose (MBq/g)\]

Outcome measures

Outcome measures
Measure
Blood Pool
n=23 Lesions
Physiologic region - Diagnostic (PET-CT and PET-MRI) arm 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
Liver
n=23 Lesions
Physiologic region - Diagnostic (PET-CT and PET-MRI) arm Physiologic region - Diagnostic (PET-CT and PET-MRI) arm 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
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
PET-CT
1.9 SUV max
Interval 1.2 to 2.5
2.3 SUV max
Interval 1.7 to 3.4
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
PET-MRI
1.3 SUV max
Interval 0.8 to 1.6
2.1 SUV max
Interval 1.6 to 3.4

PRIMARY outcome

Timeframe: Up to 6 months (each scan taking an average of 45 minutes)

Population: Participants who received PET-MRI was performed prior to the PET-CT. Evaluable lesions for this group.

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 \[tissue concentration (MBq/g) x body weight (g)\]/\[injected dose (MBq/g)\]

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 6 months (each scan taking an average of 45 minutes)

Population: Participants who received PET-CT as initial imaging followed by PET-MRI. Evaluable lesions for this group.

SUVmax in FDG avid lesions in which the PET/CT was performed prior to the PET-MRI. SUVmax is defined as \[tissue concentration (MBq/g) x body weight (g)\]/\[injected dose (MBq/g)\]

Outcome measures

Outcome measures
Measure
Blood Pool
n=16 Lesions
Physiologic region - Diagnostic (PET-CT and PET-MRI) arm 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
Liver
Physiologic region - Diagnostic (PET-CT and PET-MRI) arm Physiologic region - Diagnostic (PET-CT and PET-MRI) arm 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
SUVmax in Which the PET-CT Was Performed Prior to the PET-MRI.
PET-CT
3.0 SUV max
Interval 0.5 to 25.5
SUVmax in Which the PET-CT Was Performed Prior to the PET-MRI.
PET-MRI
3.9 SUV max
Interval 1.6 to 21.6

PRIMARY outcome

Timeframe: Up to 6 months (each scan taking an average of 45 minutes)

Population: Participants who received PET-MRI as initial imaging followed by PET-CT. Evaluable lesions for this group.

SUVmax in FDG avid lesions in which the PET-MRI was performed prior to the PET-CT SUVmax is defined as \[tissue concentration (MBq/g) x body weight (g)\]/\[injected dose (MBq/g)\]

Outcome measures

Outcome measures
Measure
Blood Pool
n=7 Lesions
Physiologic region - Diagnostic (PET-CT and PET-MRI) arm 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
Liver
Physiologic region - Diagnostic (PET-CT and PET-MRI) arm Physiologic region - Diagnostic (PET-CT and PET-MRI) arm 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
SUVmax in Which the PET-MRI Was Performed Prior to the PET-CT
PET-CT
5.9 SUV max
Interval 3.4 to 8.0
SUVmax in Which the PET-MRI Was Performed Prior to the PET-CT
PET-MRI
4.3 SUV max
Interval 2.3 to 6.3

PRIMARY outcome

Timeframe: Up to 6 months (each scan taking an average of 45 minutes)

Population: Participants who received PET-CT as initial imaging followed by PET-MRI. Evaluable lesions for this group.

SUVmax ratio in FDG avid lesions in which the PET-CT was performed prior to the PET-MRI SUVmax is defined as \[tissue concentration (MBq/g) x body weight (g)\]/\[injected dose (MBq/g)\]

Outcome measures

Outcome measures
Measure
Blood Pool
n=16 Lesions
Physiologic region - Diagnostic (PET-CT and PET-MRI) arm 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
Liver
Physiologic region - Diagnostic (PET-CT and PET-MRI) arm Physiologic region - Diagnostic (PET-CT and PET-MRI) arm 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
SUVmax Ratio in Which the PET-CT Was Performed Prior to the PET-MRI
PET-CT
2.0 SUV max ratio
Interval 0.2 to 11.1
SUVmax Ratio in Which the PET-CT Was Performed Prior to the PET-MRI
PET-MRI
2.5 SUV max ratio
Interval 0.8 to 10.8

PRIMARY outcome

Timeframe: Up to 6 months (each scan taking an average of 45 minutes)

Population: Participants who received PET-MRI as initial imaging followed by PET-CT. Evaluable lesions for this group.

SUVmax ratio in FDG avid lesions in which the PET-MRI was performed prior to the PET-CT SUVmax is defined as \[tissue concentration (MBq/g) x body weight (g)\]/\[injected dose (MBq/g)\]

Outcome measures

Outcome measures
Measure
Blood Pool
n=7 Lesions
Physiologic region - Diagnostic (PET-CT and PET-MRI) arm 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
Liver
Physiologic region - Diagnostic (PET-CT and PET-MRI) arm Physiologic region - Diagnostic (PET-CT and PET-MRI) arm 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
SUVmax Ratio in Which the PET-MRI Was Performed Prior to the PET-CT
PET-CT
2.7 SUV max
Interval 1.5 to 7.2
SUVmax Ratio in Which the PET-MRI Was Performed Prior to the PET-CT
PET-MRI
2.0 SUV max
Interval 1.2 to 7.0

PRIMARY outcome

Timeframe: Up to 6 months (each scan taking an average of 45 minutes)

Population: Evaluable lesions for this group.

True positive rate for both modalities - TP/TP+FN TP = true positives FN = False negatives

Outcome measures

Outcome measures
Measure
Blood Pool
n=23 Lesions
Physiologic region - Diagnostic (PET-CT and PET-MRI) arm 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
Liver
Physiologic region - Diagnostic (PET-CT and PET-MRI) arm Physiologic region - Diagnostic (PET-CT and PET-MRI) arm 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
True Positive Rate
PET-CT
71 percentage of true positive results
True Positive Rate
PET-MRI
71 percentage of true positive results

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure
Blood Pool
n=23 Lesions
Physiologic region - Diagnostic (PET-CT and PET-MRI) arm 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
Liver
Physiologic region - Diagnostic (PET-CT and PET-MRI) arm Physiologic region - Diagnostic (PET-CT and PET-MRI) arm 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
True Negative Rate
PET-CT
100 percent
True Negative Rate
PET-MRI
100 percent

PRIMARY outcome

Timeframe: Up to 6 months (each scan taking an average of 45 minutes)

Population: Evaluable lesions for this group.

False negative rate for both modalities - FN/FN+TP FN = False negatives TP = true positives

Outcome measures

Outcome measures
Measure
Blood Pool
n=23 Lesions
Physiologic region - Diagnostic (PET-CT and PET-MRI) arm 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
Liver
Physiologic region - Diagnostic (PET-CT and PET-MRI) arm Physiologic region - Diagnostic (PET-CT and PET-MRI) arm 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
False Negative Rate
PET-CT
29 percent
False Negative Rate
PET-MRI
14 percent

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure
Blood Pool
n=29 Lesions
Physiologic region - Diagnostic (PET-CT and PET-MRI) arm 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
Liver
Physiologic region - Diagnostic (PET-CT and PET-MRI) arm Physiologic region - Diagnostic (PET-CT and PET-MRI) arm 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
Proportion of Lesions Identified by PET-CT That Were Correctly Detected by PET-MRI
26 Lesions

PRIMARY outcome

Timeframe: Up to 6 months (each scan taking an average of 45 minutes)

Population: Evaluable lesions for this group.

Percent of true positive rate of diagnostic accuracy.

Outcome measures

Outcome measures
Measure
Blood Pool
n=23 Lesions
Physiologic region - Diagnostic (PET-CT and PET-MRI) arm 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
Liver
Physiologic region - Diagnostic (PET-CT and PET-MRI) arm Physiologic region - Diagnostic (PET-CT and PET-MRI) arm 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
Positive Predictive Values for PET-CT and PET-MRI
PET-CT
100 Percent of true positives
Positive Predictive Values for PET-CT and PET-MRI
PET-MRI
100 Percent of true positives

PRIMARY outcome

Timeframe: Up to 6 months (each scan taking an average of 45 minutes)

Population: Evaluable lesions for this group.

Percent of true negative rate of diagnostic accuracy

Outcome measures

Outcome measures
Measure
Blood Pool
n=23 Lesions
Physiologic region - Diagnostic (PET-CT and PET-MRI) arm 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
Liver
Physiologic region - Diagnostic (PET-CT and PET-MRI) arm Physiologic region - Diagnostic (PET-CT and PET-MRI) arm 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
Negative Predictive Values for PET-CT and PET-MRI
PET-MRI
83.33 Percent of true negatives
Negative Predictive Values for PET-CT and PET-MRI
PET-CT
71.43 Percent of true negatives

Adverse Events

Diagnostic (PET-CT and PET-MRI)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 6 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Raj Paspulati

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Phone: 1-800-641-2422

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place