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| ID | Type | Description | Link |
|---|---|---|---|
| 22-1677 | Other Identifier | UNC Chapel Hill IRB |
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Drug cannot be produced and scanner down.
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| Name | Class |
|---|---|
| Radiological Society of North America | OTHER |
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Purpose: The purpose of this study is to evaluate FFNP PET/MRI's utility for predicting response to Levonorgestrel-releasing Intrauterine Device (LR-IUD) hormonal therapy for Complex Atypical hyperplasia (CAH) and Endometrial Cancer (EC).
Participants: Eight women with histologically confirmed CAH or Grade 1 EC who have planned treatment with LR-IUD will be recruited..
Procedures (methods): The is a prospective, single arm, pilot study of 8 participants who will receive one FFNP PET/MRI scan. Medical records will be followed for 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18F-fluorofuranylnorprogesterone PET / MRI | Experimental | All enrolled subjects will receive the tracer and then have a PET/MRI scan. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-fluorofuranylnorprogesterone PET / MRI | Drug | Subjects will receive a PET/MRI with 18F-fluorofuranylnorprogesterone tracer |
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| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of 18F-fluorofuranylnorprogesterone (FFNP) PET/MRI for predicting response to progestin therapy in CAH /EC patients | The sensitivity of FFNP PET /MR is defined as the ability of readers (radiologists) to correctly detect areas that will respond to treatment, as determined by histopathologic evaluation. | Upon completion of all study image data collection for all participants [approximately 1 year] |
| Specificity of 18F-fluorofuranylnorprogesterone (FFNP) PET/MRI for predicting response to progestin therapy in CAH /EC patients | The specificity is similarly defined as the ability of readers to determine areas that will fail to respond to treatment, as determined by histopathologic evaluation. | Upon completion of all study image data collection for all participants [approximately 1 year] |
| Measure | Description | Time Frame |
|---|---|---|
| Correlate FFNP Mean Standardized Uptake Value (SUVmean) at baseline and on repeat examination with estrogen and progesterone receptor expression in the CAH/EC tissues at baseline and after 6 months of treatment. | The association between SUVmean and tumor volume and the degree of estrogen/progesterone receptor will be evaluated using random coefficient trajectory models, separately for each outcome. These models allow a separate outcome trajectory for each patient, accounting for within-patient correlations arising from the fact that measurements are taken at multiple timepoints. Estrogen/progesterone receptor will be included as a fixed effect, along with the interaction of this fixed effect and time. A p-value <0.05 for this interaction will be considered evidence that the association between the outcome and estrogen/progesterone receptor varies by time. A patient-level random intercept will be included in the models. Differences in predicted means of the outcomes at each time point will be computed and tested to see if they differ from 0; p-values <0.05 for these tests will be considered evidence of a difference in predicted means by estrogen/progesterone values. |
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Inclusion Criteria:
Exclusion Criteria:
Participant eligibility is based on the biological gender assigned at birth.
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| Name | Affiliation | Role |
|---|---|---|
| Jorge Oldan, MD | University of North Carolina, Chapel Hill | Principal Investigator |
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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 the University of North Carolina (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 | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Upon completion of all study image data collection for all participants [approximately 1 year] |
| Correlate FFNP Maximum Standardized Uptake Value (SUVmax) at baseline and on repeat examination with estrogen and progesterone receptor expression in the CAH/EC tissues at baseline and after 6 months of treatment. | The association between SUVmax and tumor volume and the degree of estrogen/progesterone receptor will be evaluated using random coefficient trajectory models, separately for each outcome. These models allow a separate outcome trajectory for each patient, accounting for within-patient correlations arising from the fact that measurements are taken at multiple timepoints. Estrogen/progesterone receptor will be included as a fixed effect, along with the interaction of this fixed effect and time. A p-value <0.05 for this interaction will be considered evidence that the association between the outcome and estrogen/progesterone receptor varies by time. A patient-level random intercept will be included in the models. Differences in predicted means of the outcomes at each time point will be computed and tested to see if they differ from 0; p-values <0.05 for these tests will be considered evidence of a difference in predicted means by estrogen/progesterone values. | Upon completion of all study image data collection for all participants [approximately 1 year] |
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |