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| ID | Type | Description | Link |
|---|---|---|---|
| 97807 | Other Identifier | Stanford University Alternate IRB Approval Number | |
| RENAL0013 | Other Identifier | OnCore |
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| Name | Class |
|---|---|
| National Comprehensive Cancer Network | NETWORK |
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To learn whether Flourine-18 Fluoro-deoxi-glucose positron emission tomography / computed tomography (F-18 FDG PET/CT) and dynamic contrast enhanced magnetic resonance imaging (DCE MRI) are better predictors of response to therapy than the current standard of care (CT or MRI).
This is a single arm prospective trial in patients with newly-diagnosed advanced renal cell cancer (RCC) who were scheduled for sunitinib therapy and utilized an extensive panel of quantitative metrics on baseline and interim FDG PET/CT to evaluate the predictive utility of each of these measurements.
The objectives were to evaluate the FDG PET/CT measurement parameters for prediction of prognosis after sunitinib therapy in patients with RCC using histopathologic (post-therapy nephrectomy) or clinical follow-up for validation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| F-18 FDG PET/CT and DCE MRI | Experimental | FDG PET CT F-18 Fluoro-deoxi-glucose: 15 mCi iv Gadolinium-DTPA: 0.1 mmol/kg Sunitinib: 50 mg/day po |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FDG PET CT | Procedure | nuclear medicine imaging technique which produces a three-dimensional image or picture of functional processes in the body |
|
| Measure | Description | Time Frame |
|---|---|---|
| F-18 FDG Tumor Uptake (SUV Max) | The maximum standardized uptake value (SUVmax) is a measurement of tumor metabolism as determined by the PET scan before and after 12-weeks of sunitinib therapy. Decreased SUVmax correlates to a reduction of tumor metabolism. Increased SUVmax correlates to an increase in tumor metabolism. Reduction or increased SUVmax will be determined as the change from baseline in uptake of F18 FDG. Results were based on the European Organization for Research and Treatment of Cancer (EORTC) for predicting progression free survival. EORTC criteria is a ± 25% change of SUVmax for assessment of progressive disease, stable disease and partial response. | 12 weeks minus baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Histopathology | Histopathologic findings were correlated to the pre-treatment 18F-fluorodeoxyglucose positron emission tomography (F-18 FDG PET/CT) scan. Outcome is reported as the number of participants for whom both histopathology and F-18 FDG PET/CT indicated that active cancers was present. | 1 day |
| Initial Comprehensive Metabolic Panel |
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Inclusion Criteria:- Measurable disease by RECIST criteria
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| Name | Affiliation | Role |
|---|---|---|
| Dr Andrew Quon | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
De-identified (anonymized) patient data is routinely provided upon request. Protecting patient privacy and confidentiality is the utmost consideration when sharing individual patient data. In all cases of data sharing, patient data is always anonymized to protect privacy. All potential identifiers (name, hospital ID, address,etc) are removed.
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Seventeen previously untreated adult patients with advanced stage IV renal cell carcinoma (RCC) were prospectively recruited to Stanford Hospital and Clinics for a baseline PET/CT scan followed by a 12-month follow-up PET/CT scan post sunitinib therapy.
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| ID | Title | Description |
|---|---|---|
| FG000 | F-18 FDG PET/CT and DCE MRI | 15 mCi iv F-18 FDG PET/CT scan and DCE MRI using Gadolinium-DTPA: 0.1 mmol/kg iv followed by Sunitinib therapy at 50 mg/day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline PET/CT |
| |||||||||||||
| Interim PET/CT |
| |||||||||||||
| 12-month Follow-up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | F-18 FDG PET/CT and DCE MRI | FDG PET CT F-18 Fluoro-deoxi-glucose: 15 mCi iv Gadolinium-DTPA: 0.1 mmol/kg Sunitinib: 50 mg/day po FDG PET CT: nuclear medicine imaging technique which produces a three-dimensional image or picture of functional processes in the body DCE MRI: DCE MRI will be acquired using rapid intravenous bolus of gadolinium-DTPA (0.1 mmol/kg). F-18 Fluoro-deoxi-glucose: 15 mCi iv Gadolinium-DTPA: 0.1 mmol/kg iv Sunitinib: 50 mg/day po |
| 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 | F-18 FDG Tumor Uptake (SUV Max) | The maximum standardized uptake value (SUVmax) is a measurement of tumor metabolism as determined by the PET scan before and after 12-weeks of sunitinib therapy. Decreased SUVmax correlates to a reduction of tumor metabolism. Increased SUVmax correlates to an increase in tumor metabolism. Reduction or increased SUVmax will be determined as the change from baseline in uptake of F18 FDG. Results were based on the European Organization for Research and Treatment of Cancer (EORTC) for predicting progression free survival. EORTC criteria is a ± 25% change of SUVmax for assessment of progressive disease, stable disease and partial response. | All patients underwent baseline F-18 FDG PET scan. Mean SUVmax at baseline is reported (row 1). 6 participants achieved progression-free survival after post-sunitinib therapy, and their SUVmax values were averaged (row 2). 11 participants had progression or recurrence/relapse of disease and their SUVmax values were averaged (row 3). | Posted | Mean | Standard Deviation | SUVmax | 12 weeks minus baseline |
|
up to 12 months
No adverse events were noted, and none are reported.
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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 | F-18 FDG PET/CT and DCE MRI | 15 mCi iv F-18 FDG PET/CT scan and DCE MRI using Gadolinium-DTPA: 0.1 mmol/kg iv followed by Sunitinib therapy at 50 mg/day. |
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The utility of the MRI- and CT-scans was significantly limited by low image quality.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Quon, M.D. Professor Division of Nuclear Medicine | David Geffen School of Medicine at UCLA | 310-983-1419 | aquon@mednet.ucla.edu |
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| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| D019788 | Fluorodeoxyglucose F18 |
| D019786 | Gadolinium DTPA |
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D003847 | Deoxyglucose |
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|
| DCE MRI | Procedure | DCE MRI will be acquired using rapid intravenous bolus of gadolinium-DTPA (0.1 mmol/kg). |
|
|
| F-18 Fluoro-deoxi-glucose | Drug | 15 mCi iv |
|
|
| Gadolinium-DTPA | Drug | 0.1 mmol/kg iv |
|
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| Sunitinib | Drug | 50 mg/day po |
|
|
A comprehensive metabolic panel is a blood test that measures sugar (glucose) level, electrolyte and fluid balance, kidney function, and liver function. It was performed prior to the administration of gadolinium contrast. For patients with normal renal function, approximately 90% of gadolinium contrast is excreted through the urinary system. These patients have known renal cell carcinoma, so it was important to perform a metabolic function panel prior to gadolinium injection, specifically to determine kidney function. Reported as the number of patients for whom the initial comprehensive metabolic panel was within institutional standards. |
| Prior to baseline DCE MRI |
| Adverse Events | Adverse events were monitored for on F-18 FDG PET/CT and DCE MRI imaging days: baseline (n=17); interim (n=12); and post-sunitinib therapy (n=17). Reported as the overall number of adverse events experienced. | up to 12 months |
| Tumor Necrosis | The degree of tumor necrosis was measured using values obtained from dynamic contrast enhanced magnetic resonance imaging (DCE MRI) pre- and post-sunitinib therapy. Gadolinium contrast material given intravenously during the DCE MRI scan is used to improve visualization of blood vessels, tumors, and/or organs. | 12 weeks |
| Tumor Size by Computed Tomography (CT) Scan | Tumor size was measured based on computed tomography (CT) pre- and post-sunitinib therapy. CT was performed immediately prior to the PET scan and is used to determine both the PET scan imaging area and PET image attenuation correction (AC). F-18 FDG PET provides the metabolic and physiologic data while CT provides the anatomical data. | 12 weeks |
| Tumor Size by DCE Magnetic Resonance Imaging (MRI) Scan | Tumor size was measured using values obtained from DCE MRI pre- and post-sunitinib therapy. Gadolinium contrast material given intravenously during the DCE MRI scan is used to improve visualization of blood vessels, tumors, and/or organs. | 12 weeks |
| DCE MRI AUC Peak Flow | Area under the curve (AUC) was measured using receiver operating characteristic (ROC) curve analysis. ROC curve analysis measures sensitivity (true-positives, correctly diagnosed positive pathologies) against specificity (true-negatives, correctly diagnosed negative pathologies or free of disease) of the DCE MRI scan. An area of 1.0 under the curve would equal a perfect test (with 100% sensitivity; 100% specificity) while an area of 0.5 would equal a useless test (50% sensitivity; 50% specificity). | 12 weeks |
| Initial Tumor Size | Initial tumor size was measured using values obtained from computed tomography (CT) pre-sunitinib therapy. CT is performed immediately prior to the PET scan and is used to determine both the PET scan imaging area and PET image attenuation correction (AC). F-18 FDG PET provides the metabolic and physiologic data while CT provides the anatomical data. | pre-sunitinib therapy |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Stanford Hospital and Clinics | Number | participants |
|
| OG000 | F-18 FDG PET/CT and DCE MRI | 15 mCi iv F-18 FDG PET/CT scan |
|
|
| Secondary | Histopathology | Histopathologic findings were correlated to the pre-treatment 18F-fluorodeoxyglucose positron emission tomography (F-18 FDG PET/CT) scan. Outcome is reported as the number of participants for whom both histopathology and F-18 FDG PET/CT indicated that active cancers was present. | Patients with renal cell carcinoma | Posted | Count of Participants | Participants | 1 day |
|
|
|
| Secondary | Initial Comprehensive Metabolic Panel | A comprehensive metabolic panel is a blood test that measures sugar (glucose) level, electrolyte and fluid balance, kidney function, and liver function. It was performed prior to the administration of gadolinium contrast. For patients with normal renal function, approximately 90% of gadolinium contrast is excreted through the urinary system. These patients have known renal cell carcinoma, so it was important to perform a metabolic function panel prior to gadolinium injection, specifically to determine kidney function. Reported as the number of patients for whom the initial comprehensive metabolic panel was within institutional standards. | Posted | Count of Participants | Participants | Prior to baseline DCE MRI |
|
|
|
| Secondary | Adverse Events | Adverse events were monitored for on F-18 FDG PET/CT and DCE MRI imaging days: baseline (n=17); interim (n=12); and post-sunitinib therapy (n=17). Reported as the overall number of adverse events experienced. | Posted | Number | adverse events | up to 12 months |
|
|
|
| Secondary | Tumor Necrosis | The degree of tumor necrosis was measured using values obtained from dynamic contrast enhanced magnetic resonance imaging (DCE MRI) pre- and post-sunitinib therapy. Gadolinium contrast material given intravenously during the DCE MRI scan is used to improve visualization of blood vessels, tumors, and/or organs. | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Secondary | Tumor Size by Computed Tomography (CT) Scan | Tumor size was measured based on computed tomography (CT) pre- and post-sunitinib therapy. CT was performed immediately prior to the PET scan and is used to determine both the PET scan imaging area and PET image attenuation correction (AC). F-18 FDG PET provides the metabolic and physiologic data while CT provides the anatomical data. | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Secondary | Tumor Size by DCE Magnetic Resonance Imaging (MRI) Scan | Tumor size was measured using values obtained from DCE MRI pre- and post-sunitinib therapy. Gadolinium contrast material given intravenously during the DCE MRI scan is used to improve visualization of blood vessels, tumors, and/or organs. | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Secondary | DCE MRI AUC Peak Flow | Area under the curve (AUC) was measured using receiver operating characteristic (ROC) curve analysis. ROC curve analysis measures sensitivity (true-positives, correctly diagnosed positive pathologies) against specificity (true-negatives, correctly diagnosed negative pathologies or free of disease) of the DCE MRI scan. An area of 1.0 under the curve would equal a perfect test (with 100% sensitivity; 100% specificity) while an area of 0.5 would equal a useless test (50% sensitivity; 50% specificity). | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Secondary | Initial Tumor Size | Initial tumor size was measured using values obtained from computed tomography (CT) pre-sunitinib therapy. CT is performed immediately prior to the PET scan and is used to determine both the PET scan imaging area and PET image attenuation correction (AC). F-18 FDG PET provides the metabolic and physiologic data while CT provides the anatomical data. | Posted | Count of Participants | Participants | pre-sunitinib therapy |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |
| D004369 | Pentetic Acid |
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D056831 | Coordination Complexes |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |