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

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).

Study Overview

• Status: Completed
• Conditions: Kidney Neoplasms; Carcinoma, Renal Cell; Kidney (Renal Cell) Cancer
• Intervention / Treatment: Procedure: FDG PET CT; Procedure: DCE MRI; Drug: F-18 Fluoro-deoxi-glucose; Drug: Gadolinium-DTPA; Drug: Sunitinib

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 Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Positron emission tomography (PET); Procedure: DCE MRI; DCE MRI will be acquired using rapid intravenous bolus of gadolinium-DTPA (0.1 mmol/kg).; Other Names: Magnetic Resonance Imaging; Drug: F-18 Fluoro-deoxi-glucose; 15 mCi iv; Other Names: FDG; 18F-FDG; Fludeoxyglucose (18F); fluorodeoxyglucose (18F); Drug: Gadolinium-DTPA; 0.1 mmol/kg iv; Other Names: gadopentetate dimeglumine; Gd-DTPA; Gadopentetic acid; Berlex; Drug: Sunitinib; 50 mg/day po; Other Names: Sutent; SU11248

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Comprehensive Cancer Network

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (ACTUAL): October 1, 2011
• Study Completion (ACTUAL): April 1, 2012

Study Registration Dates

• First Submitted: September 26, 2007
• First Submitted That Met QC Criteria: September 27, 2007
• First Posted (ESTIMATE): September 28, 2007

Study Record Updates

• Last Update Posted (ACTUAL): June 14, 2017
• Last Update Submitted That Met QC Criteria: May 12, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell; Carcinoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Radiopharmaceuticals; Protein Kinase Inhibitors; Fluorodeoxyglucose F18; Sunitinib
• Other Study ID Numbers: IRB-08558; 97807 (OTHER: Stanford University Alternate IRB Approval Number); RENAL0013 (OTHER: OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.