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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-02342 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 7184 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| P01CA042045 | U.S. NIH Grant/Contract | View source | |
| U01CA148131 | U.S. NIH Grant/Contract | View source | |
| RG1711032 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
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Terminated due to low accrual
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This clinical trial studies use of F-18 16 alpha-fluoroestradiol ([F-18] FES) positron emission tomography (PET)/computed tomography (CT) in measuring tumor hormone receptor expression in patients undergoing endocrine-targeted therapy for newly diagnosed breast cancer or breast cancer that has come back or spread to other places in the body. Comparing results of diagnostic procedures done before, during, and after hormone therapy may help measure a patient's response to treatment.
PRIMARY OBJECTIVES:
I. Measure the effect of endocrine targeted therapy on estrogen receptor (ER) expression and estradiol binding to the receptor using serial FES PET and fludeoxyglucose F-18 (FDG) PET.
SECONDARY OBJECTIVES:
I. Document the safety profile of FES PET in patients with breast cancer.
II. Examine associations between FES PET results and serial measurements of hormone or other levels in peripheral blood, as related to efficacy of endocrine-targeted therapy. Correlate FES PET uptake measures with histopathological assays and tumor microenvironment studies on biopsy specimens, if relevant to specific treatment regimen.
OUTLINE:
Patients undergo F-18 FES PET/CT scan at baseline. Patients also undergo F-18 FES PET/CT and FDG PET/CT between 1-12 weeks after starting therapy, and then 1-12 weeks after the second FES PET/CT scan. Repeat FDG PET may be omitted in patients on selective estrogen receptor degrader.
After completion of study, patients are followed up for up to 20 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (F-18 FES PET/CT) | Experimental | Patients undergo F-18 FES PET/CT scan at baseline. Patients also undergo F-18 FES PET/CT and FDG PET/CT between 1-12 weeks after starting therapy, and then 1-12 weeks after the second FES PET/CT scan. Repeat FDG PET may be omitted in patients on selective estrogen receptor degrader. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computed Tomography | Procedure | Undergo F-18 FES PET/CT |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in F-18 16 Alpha-fluoroestradiol (FES) Standardized Uptake Value (SUV), Assessed by a One-sample Test of the Percent Change in FES SUV | Uptake was quantified using lean body mass adjusted SUV (SULmean). The geometric mean was calculated for up to 3 lesions per patient. Systematic change in FES SULgmean between baseline and a second FES scan at approximately 2 or 8 weeks and a third FES scan was at approximately 8 weeks measured using a sign test where the median change is zero. | from time of first F-18 FES-PET/CT scan to time of second or third F-18 FES-PET/CT scan (approximately 2-8 weeks) |
| F-18 16 Alpha-fluoroestradiol (FES) Uptake | Quantitative and qualitative measures of FES uptake for each disease site, a set of 1.5 cm diameter regions on three adjacent planes with the highest lesion FES uptake will be drawn to determine maximal FES uptake. Up to 10 sites seen on the static torso survey will be quantified. Lesions will qualitatively determined to be visible or not visible. | from time of first F-18 FES-PET/CT scan to time of second or third F-18 FES-PET/CT scan (approximately 2-8 weeks) |
| Proportion of Patients Experienced a Threshold in Percentage Change, or Surpassed a Targeted Follow-up F-18 16 Alpha-fluoroestradiol (FES) Standardized Uptake Value (SUV) | The number of patients showing a 20% increase in FES SULgmean compared to baseline at either 2 or 8 weeks using a 90% Wilson score binomial confidence interval. | from time of first F-18 FES-PET/CT scan to time of second or third F-18 FES-PET/CT scan (approximately 2-8 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Disease Progression | Months from the start of endocrine therapy to the time the patient is first recorded as having disease progression, | from start of therapy up to 20 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hannah Linden | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diagnostic (F-18 FES PET/CT) | Patients undergo F-18 FES PET/CT scan at baseline. Patients also undergo F-18 FES PET/CT and FDG PET/CT between 1-12 weeks after starting therapy, and then 1-12 weeks after the second FES PET/CT scan. Repeat FDG PET may be omitted in patients on selective estrogen receptor degrader. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Mar 20, 2019 |
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| Computed Tomography | Procedure | Undergo FDG PET/CT |
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| F-18 16 Alpha-Fluoroestradiol | Drug | Undergo F-18 FES PET/CT |
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| Fludeoxyglucose F-18 | Drug | Undergo FDG PET/CT |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
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| Positron Emission Tomography | Procedure | Undergo F-18 FES PET/CT |
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| Positron Emission Tomography | Procedure | Undergo FDG PET/CT |
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| COMPLETED |
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| NOT COMPLETED |
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23 patients were co-enrolled in a vorinostat therapy study. The remaining 6 patients were enrolled in studies involving potential estrogen receptor blocking therapy.
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| ID | Title | Description |
|---|---|---|
| BG000 | Diagnostic (F-18 FES PET/CT) | Patients undergo F-18 FES PET/CT scan at baseline. Patients also undergo F-18 FES PET/CT and FDG PET/CT between 1-12 weeks after starting therapy, and then 1-12 weeks after the second FES PET/CT scan. Repeat FDG PET may be omitted in patients on selective estrogen receptor degrader. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Change in F-18 16 Alpha-fluoroestradiol (FES) Standardized Uptake Value (SUV), Assessed by a One-sample Test of the Percent Change in FES SUV | Uptake was quantified using lean body mass adjusted SUV (SULmean). The geometric mean was calculated for up to 3 lesions per patient. Systematic change in FES SULgmean between baseline and a second FES scan at approximately 2 or 8 weeks and a third FES scan was at approximately 8 weeks measured using a sign test where the median change is zero. | 15/23 patients underwent a second FES PET/CT scan approximately 2 wks after starting potential ER modulating (vorinostat) therapy. 14/23 underwent a second or third FES PET/CT scan approximately 8 wks after starting vorinostat therapy. 6 patients underwent a second FES PET/CT scan between 2-8 wks after starting potential ER blocking therapy. | Posted | Median | Full Range | percentage of change in SULgmean | from time of first F-18 FES-PET/CT scan to time of second or third F-18 FES-PET/CT scan (approximately 2-8 weeks) |
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| Primary | F-18 16 Alpha-fluoroestradiol (FES) Uptake | Quantitative and qualitative measures of FES uptake for each disease site, a set of 1.5 cm diameter regions on three adjacent planes with the highest lesion FES uptake will be drawn to determine maximal FES uptake. Up to 10 sites seen on the static torso survey will be quantified. Lesions will qualitatively determined to be visible or not visible. | quantitative and qualitative measure of FES positive lesions | Posted | Count of Units | number of ER+ lesions | from time of first F-18 FES-PET/CT scan to time of second or third F-18 FES-PET/CT scan (approximately 2-8 weeks) | number of ER+ lesions | number of ER+ lesions |
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| Primary | Proportion of Patients Experienced a Threshold in Percentage Change, or Surpassed a Targeted Follow-up F-18 16 Alpha-fluoroestradiol (FES) Standardized Uptake Value (SUV) | The number of patients showing a 20% increase in FES SULgmean compared to baseline at either 2 or 8 weeks using a 90% Wilson score binomial confidence interval. | The patient arms different from Primary Outcome 1 because they are separated according to the type of therapy each group had (ER modulating or ER blocking), not by the number of FES scans that they had. Results are based on the change between 2 scans. | Posted | Number | 90% Confidence Interval | Proportion of participants | from time of first F-18 FES-PET/CT scan to time of second or third F-18 FES-PET/CT scan (approximately 2-8 weeks) |
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| Secondary | Time to Disease Progression | Months from the start of endocrine therapy to the time the patient is first recorded as having disease progression, | Posted | Median | Full Range | months | from start of therapy up to 20 years |
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Patients were monitored after each injection of FES for 24 hours (up to 3 injections over approximately 8 weeks)
This is an imaging study. No adverse events are expected or have been reported due to tracer injection or imaging. All deaths were due to the natural course of metastatic breast cancer after the time period that adverse events were collected for this study. Any adverse events due to therapy are reported in a separate study in which these patients were co-enrolled (ID: 7841) and Sanofi TED14856 (SAR439859)
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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 | Diagnostic (F-18 FES PET/CT) | Patients undergo F-18 FES PET/CT scan at baseline. Patients also undergo F-18 FES PET/CT and FDG PET/CT between 1-12 weeks after starting therapy, and then 1-12 weeks after the second FES PET/CT scan. | 24 | 29 | 0 | 29 | 0 | 29 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hannah M Linden | University of Washington | 206-606-2053 | hmlinden@uw.edu |
| Nov 20, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C043436 | 16-fluoroestradiol |
| D019788 | Fluorodeoxyglucose F18 |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| number of ER+ lesions |
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| Units | Counts |
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| Participants |
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