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Evaluating Sunitinib Therapy in Renal Cell Carcinoma Using F-18 FDG PET/CT and DCE MRI

Primary Purpose

Kidney Neoplasms, Carcinoma, Renal Cell, Kidney (Renal Cell) Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FDG PET CT
DCE MRI
F-18 Fluoro-deoxi-glucose
Gadolinium-DTPA
Sunitinib
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Kidney Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:- Measurable disease by RECIST criteria

  • Pathologic diagnosis of renal cell cancer
  • Advanced (stage IV) renal cell cancer
  • Karnofsky performance status of (KPS>70)
  • Consent to participate in the clinical trial Exclusion Criteria:- Patients who cannot complete a PET/CT scan.
  • Pregnant women.
  • Healthy volunteers.
  • Patients participating in other research protocols will be excluded from this study.
  • Metallic implants (prosthesis, ICD, pacemakers), since these are contraindications for MRI.

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

F-18 FDG PET/CT and DCE MRI

Arm Description

FDG PET CT F-18 Fluoro-deoxi-glucose: 15 mCi iv Gadolinium-DTPA: 0.1 mmol/kg Sunitinib: 50 mg/day po

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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).
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.

Full Information

First Posted
September 26, 2007
Last Updated
May 12, 2017
Sponsor
Stanford University
Collaborators
National Comprehensive Cancer Network
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1. Study Identification

Unique Protocol Identification Number
NCT00537056
Brief Title
Evaluating Sunitinib Therapy in Renal Cell Carcinoma Using F-18 FDG PET/CT and DCE MRI
Official Title
Evaluating Sunitinib Therapy in Renal Cell Carcinoma Using F-18 FDG PET/CT and DCE MRI
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Comprehensive Cancer Network

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Neoplasms, Carcinoma, Renal Cell, Kidney (Renal Cell) Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
F-18 FDG PET/CT and DCE MRI
Arm Type
Experimental
Arm Description
FDG PET CT F-18 Fluoro-deoxi-glucose: 15 mCi iv Gadolinium-DTPA: 0.1 mmol/kg Sunitinib: 50 mg/day po
Intervention Type
Procedure
Intervention Name(s)
FDG PET CT
Other Intervention Name(s)
Positron emission tomography (PET)
Intervention Description
nuclear medicine imaging technique which produces a three-dimensional image or picture of functional processes in the body
Intervention Type
Procedure
Intervention Name(s)
DCE MRI
Other Intervention Name(s)
Magnetic Resonance Imaging
Intervention Description
DCE MRI will be acquired using rapid intravenous bolus of gadolinium-DTPA (0.1 mmol/kg).
Intervention Type
Drug
Intervention Name(s)
F-18 Fluoro-deoxi-glucose
Other Intervention Name(s)
fluorodeoxyglucose (18F), Fludeoxyglucose (18F), 18F-FDG, FDG
Intervention Description
15 mCi iv
Intervention Type
Drug
Intervention Name(s)
Gadolinium-DTPA
Other Intervention Name(s)
Gadopentetic acid, gadopentetate dimeglumine, Gd-DTPA, Berlex
Intervention Description
0.1 mmol/kg iv
Intervention Type
Drug
Intervention Name(s)
Sunitinib
Other Intervention Name(s)
Sutent, SU11248
Intervention Description
50 mg/day po
Primary Outcome Measure Information:
Title
F-18 FDG Tumor Uptake (SUV Max)
Description
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.
Time Frame
12 weeks minus baseline
Secondary Outcome Measure Information:
Title
Histopathology
Description
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.
Time Frame
1 day
Title
Initial Comprehensive Metabolic Panel
Description
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.
Time Frame
Prior to baseline DCE MRI
Title
Adverse Events
Description
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.
Time Frame
up to 12 months
Title
Tumor Necrosis
Description
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.
Time Frame
12 weeks
Title
Tumor Size by Computed Tomography (CT) Scan
Description
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.
Time Frame
12 weeks
Title
Tumor Size by DCE Magnetic Resonance Imaging (MRI) Scan
Description
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.
Time Frame
12 weeks
Title
DCE MRI AUC Peak Flow
Description
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).
Time Frame
12 weeks
Title
Initial Tumor Size
Description
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.
Time Frame
pre-sunitinib therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:- Measurable disease by RECIST criteria Pathologic diagnosis of renal cell cancer Advanced (stage IV) renal cell cancer Karnofsky performance status of (KPS>70) Consent to participate in the clinical trial Exclusion Criteria:- Patients who cannot complete a PET/CT scan. Pregnant women. Healthy volunteers. Patients participating in other research protocols will be excluded from this study. Metallic implants (prosthesis, ICD, pacemakers), since these are contraindications for MRI.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Andrew Quon
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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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Evaluating Sunitinib Therapy in Renal Cell Carcinoma Using F-18 FDG PET/CT and DCE MRI

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