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

• ClinicalTrials.gov Identifier: NCT00537056
• Recruitment Status: Completed
• First Posted: September 28, 2007
• Results First Posted: June 14, 2017
• Last Update Posted: June 14, 2017
• Sponsor: Stanford University
• Collaborator: National Comprehensive Cancer Network
• Information provided by (Responsible Party): Andrew Quon, Stanford University

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).

Condition or disease	Intervention/treatment	Phase
Kidney Neoplasms; Carcinoma, Renal Cell; Kidney (Renal Cell) Cancer	Procedure: FDG PET CT; Procedure: DCE MRI; Drug: F-18 Fluoro-deoxi-glucose; Drug: Gadolinium-DTPA; Drug: Sunitinib	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 17 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Evaluating Sunitinib Therapy in Renal Cell Carcinoma Using F-18 FDG PET/CT and DCE MRI
• Study Start Date: October 2007
• Actual Primary Completion Date: October 2011
• Actual Study Completion Date: April 2012

Arms and Interventions

Arm

Intervention/treatment

Experimental: 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

Procedure: FDG PET CT; nuclear medicine imaging technique which produces a three-dimensional image or picture of functional processes in the body; Other Name: Positron emission tomography (PET); Procedure: DCE MRI; DCE MRI will be acquired using rapid intravenous bolus of gadolinium-DTPA (0.1 mmol/kg).; Other Name: Magnetic Resonance Imaging; Drug: F-18 Fluoro-deoxi-glucose; 15 mCi iv; Other Names: fluorodeoxyglucose (18F); Fludeoxyglucose (18F); 18F-FDG; FDG; Drug: Gadolinium-DTPA; 0.1 mmol/kg iv; Other Names: Gadopentetic acid; gadopentetate dimeglumine; Gd-DTPA; Berlex; Drug: Sunitinib; 50 mg/day po; Other Names: Sutent; SU11248

Outcome Measures

Primary Outcome Measures :

1. F-18 FDG Tumor Uptake (SUV Max) [ Time Frame: 12 weeks minus baseline ]

   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 :

1. Histopathology [ Time Frame: 1 day ]
   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.
2. Initial Comprehensive Metabolic Panel [ Time Frame: Prior to baseline DCE MRI ]
   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.
3. Adverse Events [ Time Frame: up to 12 months ]
   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.
4. Tumor Necrosis [ Time Frame: 12 weeks ]
   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.
5. Tumor Size by Computed Tomography (CT) Scan [ Time Frame: 12 weeks ]
   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.
6. Tumor Size by DCE Magnetic Resonance Imaging (MRI) Scan [ Time Frame: 12 weeks ]
   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.
7. DCE MRI AUC Peak Flow [ Time Frame: 12 weeks ]
   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).
8. Initial Tumor Size [ Time Frame: pre-sunitinib therapy ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, California

Stanford University School of Medicine

Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

National Comprehensive Cancer Network

Investigators

• Principal Investigator: Dr Andrew Quon; Stanford University

More Information

• Responsible Party: Andrew Quon, Associate Professor of Radiology (Nuclear Medicine, Stanford University
• ClinicalTrials.gov Identifier: NCT00537056
• Other Study ID Numbers: IRB-08558; 97807 ( Other Identifier: Stanford University Alternate IRB Approval Number ); RENAL0013 ( Other Identifier: OnCore )
• First Posted: September 28, 2007
• Results First Posted: June 14, 2017
• Last Update Posted: June 14, 2017
• Last Verified: May 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.

Additional relevant MeSH terms:

Carcinoma; Carcinoma, Renal Cell; Kidney Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Sunitinib; Fluorodeoxyglucose F18; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Growth Inhibitors; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals