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

Carcinoma, Renal Cell Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00537056
• Other study ID #: RENAL0013
• Secondary ID: 97807RENAL001385
• Status: Completed
• Phase: N/A
• First received: September 26, 2007
• Last updated: April 4, 2013
• Start date: October 2007
• Est. completion date: April 2012

Study information

• Verified date: April 2013
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To learn whether FDG PET/CT and DCE MRI are better predictors of response to therapy than the current standard of care (CT or MRI).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

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

Intervention

Procedure:
• 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).

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

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Comprehensive Cancer Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	histopathology		clinical outcome usually prior to beginning on the trial	No
Primary	degree of tumor necrosis		pre and post ( 12 weeks ) sutent therapy	No
Primary	Tumor size		pre and post ( 12 weeks ) sutent therapy	No
Primary	PET/CT (tumor size - FDG uptake)		pre and post ( 12 weeks ) sutent therapy	No
Primary	MRI (tumor size)		pre and post ( 12 weeks ) sutent therapy	No
Primary	DCE MRI (AUC - peak flow)		pre and post ( 12 weeks ) sutent therapy	No
Secondary	initial imaging tumor size		pre sutent therapy	No
Secondary	adverse events		noted on imaging days	Yes
Secondary	initial metabolic panel measures		prior to baseline MRI	No