PET-MRI in Diagnosing Patients With Colon or Rectal Cancer

• Sponsor: Case Comprehensive Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01807117
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Actual Duration (Months): 11.1
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
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	Procedure: positron emission tomography; Procedure: computed tomography; Procedure: magnetic resonance imaging; Radiation: fludeoxyglucose F 18	N/A

Detailed Description

PRIMARY OBJECTIVES:

1. 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.

2. 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:

1. To test different attenuation correction MR sequences and novel diagnostic MR sequences.

OUTLINE:

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Evaluation of PET-MRI in Initial Staging of High Grade Rectal Cancer Patients and in the Follow up of Colorectal Cancer Patients.
• Actual Study Start Date: Apr 1, 2013
• Actual Primary Completion Date: Mar 5, 2014
• Actual Study Completion Date: Mar 5, 2014

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Diagnostic (PET-CT and PET-MRI) Patients undergo fludeoxyglucose F 18 PET-CT and PET-MRI.

Procedure: positron emission tomography; Undergo fludeoxyglucose F 18 PET-CT and PET-MRI; Other Names: FDG-PET PET PET scan tomography, emission computed ; Procedure: computed tomography; Undergo fludeoxyglucose F 18 PET-CT and PET-MRI; Other Names: tomography, computed ; Procedure: magnetic resonance imaging; Undergo fludeoxyglucose F 18 PET-CT and PET-MRI; Other Names: MRI NMR imaging NMRI nuclear magnetic resonance imaging ; Radiation: fludeoxyglucose F 18; Undergo fludeoxyglucose F 18 PET-CT and PET-MRI; Other Names: 18FDG FDG

Outcome Measures

Primary Outcome Measures

1. 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)]

2. 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)]

3. 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)]

4. 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)]

5. 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)]

6. 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)]

7. 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

8. 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

9. 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

10. 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

11. 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.

12. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio	United States	44106-5065

Sponsors and Collaborators

• Case Comprehensive Cancer Center

Investigators

• Principal Investigator: Raj Paspulati, MD, Case Comprehensive Cancer Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 18, 2013
• Informed Consent Form - Oct 16, 2018

More Information

Publications

None provided.

• Responsible Party: Case Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT01807117
• Other Study ID Numbers: CASE8212; NCI-2013-00511
• First Posted: Mar 8, 2013
• Last Update Posted: May 18, 2021
• Last Verified: Apr 1, 2021

• Additional relevant MeSH terms: Rectal Neoplasms; Colonic Neoplasms; Recurrence; Fluorodeoxyglucose F18

Study Results

Participant Flow

Arm/Group Title	Diagnostic (PET-CT and PET-MRI)
Arm/Group Description	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
Period Title: Overall Study
STARTED	15
COMPLETED	12
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Diagnostic (PET-CT and PET-MRI)
Arm/Group Description	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 Participants	15
Age, Customized (Count of Participants)
20-29	0 0%
30-39	0 0%
40-49	4 26.7%
50-59	3 20%
60-69	4 26.7%
70-79	4 26.7%
80-89	0 0%
Sex: Female, Male (Count of Participants)
Female	3 20%
Male	12 80%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	2 13.3%
Unknown or Not Reported	13 86.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 6.7%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	3 20%
White	0 0%
More than one race	8 53.3%
Unknown or Not Reported	3 20%
Region of Enrollment (participants) [Number]
United States	15 100%

Outcome Measures

1. Primary Outcome

Title	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
Description	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)]
Time Frame	Up to 6 months (each scan taking an average of 45 minutes)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Blood Pool	Liver
Arm/Group Description	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	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
Measure Participants	9	9
Measure Lesions	23	23
PET-CT	1.9	2.3
PET-MRI	1.3	2.1

2. Primary Outcome

Title	Maximum Standardized Uptake Value (SUVmax) in Physiologic Regions and FDG Avid Lesions in Participants Where PET-MRI Was Performed Prior to the PET-CT
Description	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)]
Time Frame	Up to 6 months (each scan taking an average of 45 minutes)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Blood Pool	Liver
Arm/Group Description	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	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
Measure Participants	0	0
Measure Lesions	0	0

3. Primary Outcome

Title	SUVmax in Which the PET-CT Was Performed Prior to the PET-MRI.
Description	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)]
Time Frame	Up to 6 months (each scan taking an average of 45 minutes)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Diagnostic (PET-CT and PET-MRI)
Arm/Group Description	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
Measure Participants	9
Measure Lesions	16
PET-CT	3.0
PET-MRI	3.9

4. Primary Outcome

Title	SUVmax in Which the PET-MRI Was Performed Prior to the PET-CT
Description	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)]
Time Frame	Up to 6 months (each scan taking an average of 45 minutes)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Diagnostic (PET-CT and PET-MRI)
Arm/Group Description	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
Measure Participants	3
Measure Lesions	7
PET-CT	5.9
PET-MRI	4.3

5. Primary Outcome

Title	SUVmax Ratio in Which the PET-CT Was Performed Prior to the PET-MRI
Description	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)]
Time Frame	Up to 6 months (each scan taking an average of 45 minutes)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Diagnostic (PET-CT and PET-MRI)
Arm/Group Description	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
Measure Participants	9
Measure Lesions	16
PET-CT	2.0
PET-MRI	2.5

6. Primary Outcome

Title	SUVmax Ratio in Which the PET-MRI Was Performed Prior to the PET-CT
Description	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)]
Time Frame	Up to 6 months (each scan taking an average of 45 minutes)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Diagnostic (PET-CT and PET-MRI)
Arm/Group Description	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
Measure Participants	3
Measure Lesions	7
PET-CT	2.7
PET-MRI	2.0

7. Primary Outcome

Title	True Positive Rate
Description	True positive rate for both modalities - TP/TP+FN TP = true positives FN = False negatives
Time Frame	Up to 6 months (each scan taking an average of 45 minutes)

Outcome Measure Data

Analysis Population Description

Evaluable lesions for this group.

Arm/Group Title	Diagnostic (PET-CT and PET-MRI)
Arm/Group Description	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
Measure Participants	12
Measure Lesions	23
PET-CT	71
PET-MRI	71

8. Primary Outcome

Title	True Negative Rate
Description	True negative rate for both modalities - TN/TN+FP TN = true negatives FP = False positives
Time Frame	Up to 6 months (each scan taking an average of 45 minutes)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diagnostic (PET-CT and PET-MRI)
Arm/Group Description	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
Measure Participants	12
Measure Lesions	23
PET-CT	100
PET-MRI	100

9. Primary Outcome

Title	False Negative Rate
Description	False negative rate for both modalities - FN/FN+TP FN = False negatives TP = true positives
Time Frame	Up to 6 months (each scan taking an average of 45 minutes)

Outcome Measure Data

Analysis Population Description

Evaluable lesions for this group.

Arm/Group Title	Diagnostic (PET-CT and PET-MRI)
Arm/Group Description	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
Measure Participants	12
Measure Lesions	23
PET-CT	29
PET-MRI	14

10. Primary Outcome

Title	Proportion of Lesions Identified by PET-CT That Were Correctly Detected by PET-MRI
Description	On a per-lesion basis, proportion of lesions identified by PET-CT that were correctly detected by PET-MRI
Time Frame	Up to 6 months (each scan taking an average of 45 minutes)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diagnostic (PET-CT and PET-MRI)
Arm/Group Description	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
Measure Participants	12
Measure Lesions	29
Number [Lesions]	26

11. Primary Outcome

Title	Positive Predictive Values for PET-CT and PET-MRI
Description	Percent of true positive rate of diagnostic accuracy.
Time Frame	Up to 6 months (each scan taking an average of 45 minutes)

Outcome Measure Data

Analysis Population Description

Evaluable lesions for this group.

Arm/Group Title	Diagnostic (PET-CT and PET-MRI)
Arm/Group Description	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
Measure Participants	12
Measure Lesions	23
PET-CT	100
PET-MRI	100

12. Primary Outcome

Title	Negative Predictive Values for PET-CT and PET-MRI
Description	Percent of true negative rate of diagnostic accuracy
Time Frame	Up to 6 months (each scan taking an average of 45 minutes)

Outcome Measure Data

Analysis Population Description

Evaluable lesions for this group.

Arm/Group Title	Diagnostic (PET-CT and PET-MRI)
Arm/Group Description	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
Measure Participants	12
Measure Lesions	23
PET-CT	71.43
PET-MRI	83.33

Adverse Events

Time Frame	Adverse events: At time of intervention, an average of 1 hour Survival: Up to 5 years
Arm/Group Title	Diagnostic (PET-CT and PET-MRI)
Arm/Group Description	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
All Cause Mortality
	Diagnostic (PET-CT and PET-MRI)
	Affected / at Risk (%)	# Events
Total	6/15 (40%)
Serious Adverse Events
	Diagnostic (PET-CT and PET-MRI)
	Affected / at Risk (%)	# Events
Total	0/15 (0%)
Other (Not Including Serious) Adverse Events
	Diagnostic (PET-CT and PET-MRI)
	Affected / at Risk (%)	# Events
Total	0/15 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.