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

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Stanford University

Status

Completed

Conditions

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

Treatments

Procedure: FDG PET CT
Drug: Gadolinium-DTPA
Drug: F-18 Fluoro-deoxi-glucose
Procedure: DCE MRI
Drug: Sunitinib

Study type

Interventional

Funder types

Other
NETWORK

Identifiers

NCT00537056
IRB-08558
97807 (Other Identifier)
RENAL0013 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment

17 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

17 participants in 1 patient group

F-18 FDG PET/CT and DCE MRI
Experimental group
Description:
FDG PET CT F-18 Fluoro-deoxi-glucose: 15 mCi iv Gadolinium-DTPA: 0.1 mmol/kg Sunitinib: 50 mg/day po
Treatment:
Drug: Sunitinib
Procedure: DCE MRI
Drug: F-18 Fluoro-deoxi-glucose
Drug: Gadolinium-DTPA
Procedure: FDG PET CT

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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