Endometriosis
Conditions
Brief summary
Purpose: The primary objective is to evaluate the sensitivity and specificity of 18F-fluoroestradiol (FES) PET/MRI for evaluating endometriosis. Participants: A total of 12 participants will be recruited from individuals with clinically suspected endometriosis who are scheduled for planned operative laparoscopy at the University of North Carolina at Chapel Hill (UNC). Procedures (methods): This is a prospective, one arm, single center study of 12 subjects with clinically suspected endometriosis to demonstrate FES PET/MR's clinical utility for diagnosis of endometriosis. This study will be an evaluation of the radiotracer, FES, which binds to estrogen receptors and has previously been used to study estrogen receptor expression in tumors, to detect endometriosis. Participants will undergo one FES PET/MR scan within 4 weeks prior to their scheduled surgery. Participants will also complete questionnaires regarding their condition, pain, and quality of life.
Detailed description
This is a prospective, one arm, single center study of 12 subjects with clinically suspected endometriosis to demonstrate FES PET-MRI's clinical utility for diagnosis of endometriosis. The primary objective is to evaluate the sensitivity and specificity of 18F-fluoroestradiol (FES) PET/MRI for evaluating endometriosis. Secondary objectives include comparing PET to conventional MRI, using histopathology from laparotomy as the gold standard and evaluating association of uptake values (SUV-max) with Endometriosis Health profile -30 (EHP-30) and pain rating scales, controlling for covariates.
Interventions
Patients will receive the FES tracer during a PET/MRI scan
Sponsors
North Carolina Translational and Clinical Sciences Institute
University of North Carolina, Chapel Hill
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 or older * Female of childbearing age * Clinically suspected (symptomatic) endometriosis. * Scheduled for planned operative laparoscopy with no hormone treatment for at least two cycles * Able to provide informed consent or assent
Exclusion criteria
* Male * Institutionalized subject (prisoner or nursing home patient) * Known history of breast, ovarian or endometrial cancer. * Pregnant or breast-feeding women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of FES PET/MRI for Evaluating Endometriosis (Percentage of Positive Scans) | day of scan, up to 2 hours | 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. |
| Specificity of FES PET/MRI for Evaluating Endometriosis (Percentage of Negative Scans) | day of scan, up to 2 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of the FES PET/MRI Specificity to Conventional MRI | day of scan, up to 2 hours | 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. |
| Mean Standard Uptake Values (SUV-max) for 18F-fluoroestradiol PET / MRI | day of scan, up to 2 hours | The SUV-max is the maximum standardized uptake value for FES within the tissue. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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: Patients will receive the FES tracer during a PET/MRI scan | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | unable to be imaged prior to surgery | 2 |
Baseline characteristics
| Characteristic | 18F-fluoroestradiol PET / MRI |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age, Continuous | 35.3 years STANDARD_DEVIATION 7.7 |
| Body Mass Index (BMI) | 26.54 kg/m^2 STANDARD_DEVIATION 4.81 |
| Endometriosis Health Profile-30 (EHP-30) | 40.7 units on a scale STANDARD_DEVIATION 28.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Pain Rating Scales (Visual Analog Scale - VAS) | 11.71 mm STANDARD_DEVIATION 25.06 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 8 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 2 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
Sensitivity of FES PET/MRI for Evaluating Endometriosis (Percentage of Positive Scans)
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 18F-fluoroestradiol PET / MRI | Sensitivity of FES PET/MRI for Evaluating Endometriosis (Percentage of Positive Scans) | 67 percentage of positive scans |
p-value: 0.317McNemar
Primary
Specificity of FES PET/MRI for Evaluating Endometriosis (Percentage of Negative Scans)
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.
Time frame: day of scan, up to 2 hours
Population: The specificity is undefined since the denominator is 0 as all participants had endometriosis.
Secondary
Correlation of the FES PET/MRI Specificity to Conventional MRI
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.
Time frame: day of scan, up to 2 hours
Population: The specificity is undefined since the denominator is 0 as all participants had endometriosis.
Secondary
Mean Standard Uptake Values (SUV-max) for 18F-fluoroestradiol PET / MRI
The SUV-max is the maximum standardized uptake value for FES within the tissue.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 18F-fluoroestradiol PET / MRI | Mean Standard Uptake Values (SUV-max) for 18F-fluoroestradiol PET / MRI | 3.23 SUV-max | Standard Deviation 3.04 |
p-value: 0.24Pearson's Correlation Coefficient
p-value: 0.13Mixed Models Analysis