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| Name | Class |
|---|---|
| North Carolina Translational and Clinical Sciences Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18F-fluoroestradiol PET / MRI | Experimental | All enrolled subjects will receive the tracer and then have a PET/MRI scan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-fluoroestradiol | Drug | Patients will receive the FES tracer during a PET/MRI scan |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | day of scan, up to 2 hours |
| 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. | day of scan, up to 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jorge Oldan, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Hospitals | Chapel Hill | North Carolina | 27599 | United States |
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
9 to 36 months following publication
The investigator who proposes to use the data has approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Two of the 8 enrolled subjects were unable to be imaged and therefore are not included in the analysis. | Posted | Number | percentage of positive scans | day of scan, up to 2 hours | scans | scans |
|
Assessed for 24 hours following the imaging procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Systematic Assessment | Patient reported fatigue lasting 4 hours following the procedure. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research, Department of Radiology | University of North Carolina at Chapel Hill | 919-966-4997 | rad_research@med.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 27, 2020 | Nov 2, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 15, 2021 | May 25, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| day of scan, up to 2 hours |
| 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. | day of scan, up to 2 hours |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Pain Rating Scales (Visual Analog Scale - VAS) | Individuals will be given a 100mm scale and asked to draw a single vertical line corresponding to the level of pain where 0mm is no pain and 100mm is pain as bad as it possibly could be. This line will be measured and the result will be recorded in mm. | One participant did not complete the VAS questionnaire. | Mean | Standard Deviation | mm |
|
| Endometriosis Health Profile-30 (EHP-30) | The Endometriosis Health Profile-30 (EHP-30), a quality of life questionnaire used in women with endometriosis, includes questions related to pain, control and powerlessness, social support, emotional wellbeing, and self-image. Each scale is standardized on a scale of 0 - 100, where 0 indicates the best health status through to 100 worst health status. Scale scores for each scale are calculated from the total of the raw scores of each item in the scale divided by the maximum possible raw score of all the items in the scale, multiplied by 100. | One participant did not complete the EHP-30 questionnaire | Mean | Standard Deviation | units on a scale |
|
| Body Mass Index (BMI) | Body Mass Index (BMI) is a person's weight in kilograms (or pounds) divided by the square of height in meters (or feet). | Mean | Standard Deviation | kg/m^2 |
|
|
|
|
| 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. | The specificity is undefined since the denominator is 0 as all participants had endometriosis. | Posted | day of scan, up to 2 hours |
|
|
| 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. | The specificity is undefined since the denominator is 0 as all participants had endometriosis. | Posted | day of scan, up to 2 hours |
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | SUV-max | day of scan, up to 2 hours | scans | scans |
|
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|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 2 |
| 6 |
|
| Change in smell | General disorders | Systematic Assessment | Subject reported change in smell for 4 hours, which was determined to be unrelated. |
|
| headache | General disorders | Systematic Assessment | Patient reported a headache that resolved, which was determined to be unrelated. |
|
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| D000091662 | Genital Diseases |
| Mixed Models Analysis |
| 0.13 |
| Slope |
| 0.406 |
| 2-Sided |
| Other |
The investigators will implement a random effects linear regression model, modeling SUV-max as a function of EHP-30, while controlling for patient-level covariates (BMI, race, age). The investigators will include physician as a random effect to account for physician-level correlation. |