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Trial Outcomes & Findings for Positron Emission Tomography/Magnetic Resonance Imaging in Patients (NCT NCT01557881)

NCT ID: NCT01557881

Last Updated: 2020-02-24

Results Overview

SUVs for various normal tissues such as liver, cardiac blood pool, and bone will be used. Selected lesions will be assessed as well. Maximum and mean SUVs will be measured for each imaging device. The SUVs and tumor/background ratios will be measured.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

98 participants

Primary outcome timeframe

After PET/MRI

Results posted on

2020-02-24

Participant Flow

Participant milestones

Participant milestones
Measure
Diagnostic (PET/MRI)
After undergoing standard PET/CT, patients undergo PET/MRI. magnetic resonance imaging with positron emission tomography scanning: University Hospitals Seidman Cancer Center \[SCC\] will house the Philips Ingenuity TF PET/MR, which is a hybrid scanner that merges magnetic resonance imaging with positron emission tomography scanning. University Hospitals is one of only five hospitals in the world with this technology. The PET/MRI system consists of two imaging scanners used sequentially as in PET/CT. The 3Tesla MRI component provides the high resolution that is necessary for soft tissue contrast and functional information on perfusion, diffusion, or metabolism. PET provides information about cellular metabolism and receptor status.
Overall Study
STARTED
98
Overall Study
COMPLETED
98
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Positron Emission Tomography/Magnetic Resonance Imaging in Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Diagnostic (PET/MRI)
n=98 Participants
After undergoing standard PET/CT, patients undergo PET/MRI. magnetic resonance imaging with positron emission tomography scanning: University Hospitals Seidman Cancer Center \[SCC\] will house the Philips Ingenuity TF PET/MR, which is a hybrid scanner that merges magnetic resonance imaging with positron emission tomography scanning. University Hospitals is one of only five hospitals in the world with this technology. The PET/MRI system consists of two imaging scanners used sequentially as in PET/CT. The 3Tesla MRI component provides the high resolution that is necessary for soft tissue contrast and functional information on perfusion, diffusion, or metabolism. PET provides information about cellular metabolism and receptor status.
Age, Customized
20-29 years
2 Participants
n=5 Participants
Age, Customized
30-39 years
6 Participants
n=5 Participants
Age, Customized
40-49 years
16 Participants
n=5 Participants
Age, Customized
50-59 years
26 Participants
n=5 Participants
Age, Customized
60-69 years
20 Participants
n=5 Participants
Age, Customized
70-79 years
20 Participants
n=5 Participants
Age, Customized
80-89 years
7 Participants
n=5 Participants
Age, Customized
90-99
1 Participants
n=5 Participants
Sex/Gender, Customized
Gender · Female
47 Participants
n=5 Participants
Sex/Gender, Customized
Gender · Male
49 Participants
n=5 Participants
Sex/Gender, Customized
Gender · Unknown
2 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
81 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
15 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
12 Participants
n=5 Participants
Race (NIH/OMB)
White
81 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
2 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants
n=5 Participants
Region of Enrollment
United States
98 participants
n=5 Participants

PRIMARY outcome

Timeframe: After PET/MRI

Population: Not available because SUV data not collected.

SUVs for various normal tissues such as liver, cardiac blood pool, and bone will be used. Selected lesions will be assessed as well. Maximum and mean SUVs will be measured for each imaging device. The SUVs and tumor/background ratios will be measured.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: After PET/MRI

Population: Not available because data not collected.

A Likert five point scale will be used. Quality scores will be compared using a Wilcoxon signed rank test.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: After PET/MRI

Population: Not available because data not collected.

A Likert five point scale will be used. Quality scores will be compared using a Wilcoxon signed rank test.

Outcome measures

Outcome data not reported

Adverse Events

Diagnostic (PET/MRI)

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

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Philipp Frank Graner

Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Phone: +1 216-844-8275

Results disclosure agreements

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