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Trial Outcomes & Findings for Evaluation of Endometriosis With 18F-fluoroestradiol PET / MRI (NCT NCT04382911)

NCT ID: NCT04382911

Last Updated: 2023-05-30

Results Overview

The sensitivity of FES PET /MRI is defined as the ability of readers (radiologists) to detect endometriosis among those with histopathologically identified endometriosis in the entire cohort. Sensitivity is calculated by dividing the number of true cases of endometriosis by the overall number of patients with endometriosis identified using the research imaging. The sensitivity data can only be calculated upon completion of study imaging for all participants.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

day of scan, up to 2 hours

Results posted on

2023-05-30

Participant Flow

Participant milestones

Participant milestones
Measure
18F-fluoroestradiol PET / MRI
All enrolled subjects will receive the tracer and then have a PET/MRI scan. A PET/MRI scan is a two-in-one test that combines images from a positron emission tomography (PET) scan and a magnetic resonance imaging (MRI) scan. 18F-fluoroestradiol (FES): Patients will receive 6 mCi of the FES tracer during a PET/MRI scan
Overall Study
STARTED
8
Overall Study
COMPLETED
6
Overall Study
NOT COMPLETED
2

Reasons for withdrawal

Reasons for withdrawal
Measure
18F-fluoroestradiol PET / MRI
All enrolled subjects will receive the tracer and then have a PET/MRI scan. A PET/MRI scan is a two-in-one test that combines images from a positron emission tomography (PET) scan and a magnetic resonance imaging (MRI) scan. 18F-fluoroestradiol (FES): Patients will receive 6 mCi of the FES tracer during a PET/MRI scan
Overall Study
unable to be imaged prior to surgery
2

Baseline Characteristics

One participant did not complete the VAS questionnaire.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
18F-fluoroestradiol PET / MRI
n=8 Participants
All enrolled subjects will receive the tracer and then have a PET/MRI scan. A PET/MRI scan is a two-in-one test that combines images from a positron emission tomography (PET) scan and a magnetic resonance imaging (MRI) scan 18F-fluoroestradiol: Patients will receive the FES tracer during a PET/MRI scan
Age, Categorical
<=18 years
0 Participants
n=8 Participants
Age, Categorical
Between 18 and 65 years
8 Participants
n=8 Participants
Age, Categorical
>=65 years
0 Participants
n=8 Participants
Age, Continuous
35.3 years
STANDARD_DEVIATION 7.7 • n=8 Participants
Sex: Female, Male
Female
8 Participants
n=8 Participants
Sex: Female, Male
Male
0 Participants
n=8 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=8 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
8 Participants
n=8 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=8 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=8 Participants
Race (NIH/OMB)
Asian
1 Participants
n=8 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=8 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=8 Participants
Race (NIH/OMB)
White
6 Participants
n=8 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=8 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=8 Participants
Region of Enrollment
United States
8 Participants
n=8 Participants
Pain Rating Scales (Visual Analog Scale - VAS)
11.71 mm
STANDARD_DEVIATION 25.06 • n=7 Participants • One participant did not complete the VAS questionnaire.
Endometriosis Health Profile-30 (EHP-30)
40.7 units on a scale
STANDARD_DEVIATION 28.3 • n=7 Participants • One participant did not complete the EHP-30 questionnaire
Body Mass Index (BMI)
26.54 kg/m^2
STANDARD_DEVIATION 4.81 • n=8 Participants

PRIMARY outcome

Timeframe: day of scan, up to 2 hours

Population: Two of the 8 enrolled subjects were unable to be imaged and therefore are not included in the analysis.

The sensitivity of FES PET /MRI is defined as the ability of readers (radiologists) to detect endometriosis among those with histopathologically identified endometriosis in the entire cohort. Sensitivity is calculated by dividing the number of true cases of endometriosis by the overall number of patients with endometriosis identified using the research imaging. The sensitivity data can only be calculated upon completion of study imaging for all participants.

Outcome measures

Outcome measures
Measure
18F-fluoroestradiol PET / MRI
n=6 scans
All enrolled subjects will receive the tracer and then have a PET/MRI scan. A PET/MRI scan is a two-in-one test that combines images from a positron emission tomography (PET) scan and a magnetic resonance imaging (MRI) scan. 18F-fluoroestradiol: Patients will receive the FES tracer during a PET/MRI scan.
Sensitivity of FES PET/MRI for Evaluating Endometriosis (Percentage of Positive Scans)
67 percentage of positive scans

PRIMARY outcome

Timeframe: day of scan, up to 2 hours

Population: The specificity is undefined since the denominator is 0 as all participants had endometriosis.

The specificity of FES PET /MRI is defined as the ability of readers (radiologists) to detect that patients do not have endometriosis divided by the number of participants without endometriosis as defined histopathologically in the entire cohort. Specificity is calculated by dividing the number of true negative cases by the overall number of patients without endometriosis identified using the research imaging. The specificity data can only be calculated upon completion of study imaging for all participants.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: day of scan, up to 2 hours

Population: The specificity is undefined since the denominator is 0 as all participants had endometriosis.

The investigators will use McNemar's test, constructing the 2x2 table among all patients with a surgical diagnosis of negative to compare specificity for FES PET/MRI (Outcome Measure 2) versus conventional MRI. The specificity of FES PET /MRI is defined as the ability of readers (radiologists) to detect that patients do not have endometriosis divided by the number of participants without endometriosis as defined histopathologically in the entire cohort. Specificity is calculated by dividing the number of true negative cases by the overall number of patients without endometriosis identified using the research imaging. The specificity data can only be calculated upon completion of study imaging for all participants.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: day of scan, up to 2 hours

Population: Two of the eight enrolled subjects were unable to be imaged and therefore are not included in the analysis because SUV-max can only be determined using the research scan.

The SUV-max is the maximum standardized uptake value for FES within the tissue.

Outcome measures

Outcome measures
Measure
18F-fluoroestradiol PET / MRI
n=6 scans
All enrolled subjects will receive the tracer and then have a PET/MRI scan. A PET/MRI scan is a two-in-one test that combines images from a positron emission tomography (PET) scan and a magnetic resonance imaging (MRI) scan. 18F-fluoroestradiol: Patients will receive the FES tracer during a PET/MRI scan.
Mean Standard Uptake Values (SUV-max) for 18F-fluoroestradiol PET / MRI
3.23 SUV-max
Standard Deviation 3.04

Adverse Events

18F-fluoroestradiol PET / MRI

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
18F-fluoroestradiol PET / MRI
n=6 participants at risk
All enrolled subjects will receive the tracer and then have a PET/MRI scan. A PET/MRI scan is a two-in-one test that combines images from a positron emission tomography (PET) scan and a magnetic resonance imaging (MRI) scan 18F-fluoroestradiol: Patients will receive the FES tracer during a PET/MRI scan
General disorders
Fatigue
16.7%
1/6 • Number of events 1 • Assessed for 24 hours following the imaging procedure.
General disorders
Change in smell
16.7%
1/6 • Number of events 1 • Assessed for 24 hours following the imaging procedure.
General disorders
headache
16.7%
1/6 • Number of events 1 • Assessed for 24 hours following the imaging procedure.

Additional Information

Director, Clinical Research, Department of Radiology

University of North Carolina at Chapel Hill

Phone: 919-966-4997

Results disclosure agreements

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