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| ID | Type | Description | Link |
|---|---|---|---|
| UW17034 / UW23007 | Other Identifier | UWCCC ID | |
| A539300 | Other Identifier | UW Madison | |
| SMPH\RADIOLOGY\RADIOLOGY | Other Identifier | UW Madison | |
| 4UL1TR000427-10 | U.S. NIH Grant/Contract | View source | |
| 1UL1TR002373-01 | U.S. NIH Grant/Contract | View source | |
| Protocol Version 11/2/2022 | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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The goal of this research is to test the accuracy of PET/MRI imaging with 18F-fluorofuranylnorprogesterone (FFNP) for measuring progesterone receptor (PR) expression in patients with invasive breast cancer. The hypothesis is that FFNP SUVmax from PET/MRI will correlate well against the semi-quantitative PR immunohistochemistry score.
Integrated whole-body magnetic resonance imaging (MRI)-positron emission tomography (PET) scanners have recently been introduced for clinical use. This technology combines the anatomic and perfusion data obtained with dynamic contrast enhanced (DCE) MRI with functional imaging data obtained from PET. For breast imaging, the combination of MRI and PET has important potential to improve diagnostic accuracy and provide molecular characterization of breast cancer. The overall purpose of this research is to test the accuracy of PET/MRI imaging with 18F-fluorofuranylnorprogesterone (FFNP) for measuring progesterone receptor (PR) expression in patients with invasive breast cancer.
This is a prospective, one-arm, study which will enroll patients with newly diagnosed breast cancer scheduled for diagnostic breast MRI for preoperative staging/extent of disease evaluation as part of standard of care. Participation in this research study includes a directed breast PET/MRI with the investigational radiopharmaceutical, FFNP. FFNP uptake of the known, biopsy-proven malignancy will be measured on the PET/MRI examinations using standardized uptake values (SUV) and tumor-to-normal tissue ratios.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FFNP PET/MRI | Experimental | 18F-Fluorofuranylnorprogesterone (FFNP) administration for PET/MRI imaging to assess biopsy-proven primary PR+ breast malignancies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F]Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging | Drug | 18F-Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging tracer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Coefficient Between FFNP Uptake and Allred Score | To compare FFNP uptake of biopsy-proven primary PR+ breast malignancies measured using PET/MRI with the reference standard of PR immunohistochemistry (IHC) using a semi-quantitative score obtained by using the Allred score (0-8; the higher the score, the more receptors were found). The correlation of the two measures will be evaluated with Pearson's correlation coefficient. The null hypothesis is H0: p0=0.50 and the alternative hypothesis is H1: p1 =0.75. | Up to 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Test-Retest Reproducibility | Tumor uptake of FFNP and the ability to reproduce this measure, will be quantified in the 5 subjects who elect to undergo a second imaging session, using summary statistics of tumor FFNP uptake for each reading for PET/MRI. The analysis will be done separately for each reader. | Up to 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Inability or unwillingness to provide informed consent to the study
Participants currently undergoing neoadjuvant chemotherapy/endocrine therapy or those who have received chemotherapy/endocrine therapy within 6 months prior to the MRI
Participants who have had neoadjuvant chemotherapy/endocrine therapy, surgical intervention, or radiation for the current biopsy-proven malignancy
Participants with breast expanders
Participants who are or might be pregnant or lactating
Participants with a contraindication to gadolinium based contrast agents, including allergy or impaired renal function (per University of Wisconsin Health Guidelines)
Participants with a history of allergic reaction attributable to compounds of similar chemical or biologic composition to FFNP
Participants in liver failure as judged by the patient's physician
Participants with standard contraindications to MRI, including claustrophobia and metallic implants incompatible with MRI
Participants requiring intravenous (IV) conscious sedation for imaging are not eligible; participants requiring mild, oral anxiolytics for the clinical MRI will be allowed to participate as long as the following criteria are met:
Participants unable to lie prone for 30 minutes for imaging
Only women are being targeted for this research as breast MRI is not utilized for male breast cancer patients which comprises only 1% of all breast cancer cases.
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| Name | Affiliation | Role |
|---|---|---|
| Amy Fowler, MD, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin, Madison | Madison | Wisconsin | 53705 | United States |
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Participants were enrolled from December 2017 to November 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | FFNP PET/MRI | 18F-Fluorofuranylnorprogesterone (FFNP) administration for Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) to assess biopsy-proven primary PR+ breast malignancies. [18F]Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging: 18F-Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging tracer |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FFNP PET/MRI | 18F-Fluorofuranylnorprogesterone (FFNP) administration for PET/MRI imaging to assess biopsy-proven primary PR+ breast malignancies. [18F]Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging: 18F-Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging tracer |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Correlation Coefficient Between FFNP Uptake and Allred Score | To compare FFNP uptake of biopsy-proven primary PR+ breast malignancies measured using PET/MRI with the reference standard of PR immunohistochemistry (IHC) using a semi-quantitative score obtained by using the Allred score (0-8; the higher the score, the more receptors were found). The correlation of the two measures will be evaluated with Pearson's correlation coefficient. The null hypothesis is H0: p0=0.50 and the alternative hypothesis is H1: p1 =0.75. | Posted | Number | correlation coefficient (rho) | Up to 1 day |
|
up to 24 hours
Adverse events occurring within 24 hours after FFNP infusion will be recorded by the study coordinator who will contact the subject within 1 to 3 days after FFNP administration.
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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 | FFNP PET/MRI | 18F-Fluorofuranylnorprogesterone (FFNP) administration for PET/MRI imaging to assess biopsy-proven primary PR+ breast malignancies. [18F]Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging: 18F-Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging tracer |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amy Fowler, MD, PhD | UW Carbone Cancer Center | 608-262-9186 | afowler@wisc.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 | Oct 18, 2023 | Aug 7, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Single Group Assignment
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| Intra and Inter-Observer Assessment |
The variability of observer assessment of tumor FFNP uptake will be measured. The intra- and inter-reader agreement of SUV values for tumor FFNP uptake will be analyzed with Bland-Altman plots and 95% limits of agreement. Analyses will be conducted on a per-lesion basis, and repeat tumors within the same patient will be assumed to be independent. |
| Up to 4 weeks |
| Correlation Coefficient Between Tumor FFNP Uptake With Oncotype DX Score | Estimate the association of tumor FFNP uptake (continuous SUVmax) with research-based Oncotype DX scores (0-100). The risk score (0-100) is generated from expression levels of sixteen cancer related genes and five reference genes. Scores are further categorized as low-risk (0-17), intermediate-risk (18-30), and high-risk (31-100). Pearson's or Spearman's rank correlation will be used to evaluate the association between FFNP uptake and research-based Oncotype DX score. The correlation coefficient (rho) and 95% confidence interval will be reported. | Up to 4 weeks |
| Distinguishing Between PR Negative and PR Positive Breast Cancer Reported as Area Under the Curve (AUC) | To evaluate the optimal cut-point of FFNP uptake for distinguishing between PR-negative and PR-positive invasive breast cancer. Receiver operating characteristic (ROC) curve analysis will be performed to determine the optimal cut-point for FFNP uptake to distinguish PR-positive from PR-negative invasive breast cancer, as defined by the clinical pathology report. The AUC for the ROCs and their respective two-sided 95% confidence intervals will be calculated using logistic regression. The optimal cut-off point will be determined by considering the FFNP uptake value with the maximum sensitivity and specificity. The analysis will be done separately for each reader, AUC is reported here. | up to 4 weeks |
| Distinguishing Between PR Negative and PR Positive Breast Cancer Reported as Optimal Cut Point | To evaluate the optimal cut-point of FFNP uptake for distinguishing between PR-negative and PR-positive invasive breast cancer. Receiver operating characteristic (ROC) curve analysis will be performed to determine the optimal cut-point for FFNP uptake to distinguish PR-positive from PR-negative invasive breast cancer, as defined by the clinical pathology report. The AUC for the ROCs and their respective two-sided 95% confidence intervals will be calculated using logistic regression. The optimal cut-off point will be determined by considering the FFNP uptake value with the maximum sensitivity and specificity. The analysis will be done separately for each reader, optimal cut point is reported here. | up to 4 weeks |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
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| Secondary | Test-Retest Reproducibility | Tumor uptake of FFNP and the ability to reproduce this measure, will be quantified in the 5 subjects who elect to undergo a second imaging session, using summary statistics of tumor FFNP uptake for each reading for PET/MRI. The analysis will be done separately for each reader. | test-retest completed on a subset of the population, only 1 participant volunteered | Posted | Mean | Standard Deviation | SUVmax | Up to 4 weeks |
|
|
|
| Secondary | Intra and Inter-Observer Assessment | The variability of observer assessment of tumor FFNP uptake will be measured. The intra- and inter-reader agreement of SUV values for tumor FFNP uptake will be analyzed with Bland-Altman plots and 95% limits of agreement. Analyses will be conducted on a per-lesion basis, and repeat tumors within the same patient will be assumed to be independent. | Posted | Mean | Standard Deviation | SUVmax | Up to 4 weeks |
|
|
|
|
| Secondary | Correlation Coefficient Between Tumor FFNP Uptake With Oncotype DX Score | Estimate the association of tumor FFNP uptake (continuous SUVmax) with research-based Oncotype DX scores (0-100). The risk score (0-100) is generated from expression levels of sixteen cancer related genes and five reference genes. Scores are further categorized as low-risk (0-17), intermediate-risk (18-30), and high-risk (31-100). Pearson's or Spearman's rank correlation will be used to evaluate the association between FFNP uptake and research-based Oncotype DX score. The correlation coefficient (rho) and 95% confidence interval will be reported. | Posted | Number | 95% Confidence Interval | correlation coefficient (rho) | Up to 4 weeks |
|
|
|
|
| Secondary | Distinguishing Between PR Negative and PR Positive Breast Cancer Reported as Area Under the Curve (AUC) | To evaluate the optimal cut-point of FFNP uptake for distinguishing between PR-negative and PR-positive invasive breast cancer. Receiver operating characteristic (ROC) curve analysis will be performed to determine the optimal cut-point for FFNP uptake to distinguish PR-positive from PR-negative invasive breast cancer, as defined by the clinical pathology report. The AUC for the ROCs and their respective two-sided 95% confidence intervals will be calculated using logistic regression. The optimal cut-off point will be determined by considering the FFNP uptake value with the maximum sensitivity and specificity. The analysis will be done separately for each reader, AUC is reported here. | Posted | Number | 95% Confidence Interval | probability | up to 4 weeks |
|
|
|
| Secondary | Distinguishing Between PR Negative and PR Positive Breast Cancer Reported as Optimal Cut Point | To evaluate the optimal cut-point of FFNP uptake for distinguishing between PR-negative and PR-positive invasive breast cancer. Receiver operating characteristic (ROC) curve analysis will be performed to determine the optimal cut-point for FFNP uptake to distinguish PR-positive from PR-negative invasive breast cancer, as defined by the clinical pathology report. The AUC for the ROCs and their respective two-sided 95% confidence intervals will be calculated using logistic regression. The optimal cut-off point will be determined by considering the FFNP uptake value with the maximum sensitivity and specificity. The analysis will be done separately for each reader, optimal cut point is reported here. | Posted | Number | SUVmax | up to 4 weeks |
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|
| 0 |
| 20 |
| 0 |
| 20 |
| 2 |
| 20 |
| Headache | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |