Imaging Correlates of Renal Cell Carcinoma Biological Features



Status:Active, not recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/14/2018
Start Date:August 2012
End Date:August 2019

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LCCC 1213: Defining Molecular and Functional Imaging Correlates of Renal Cell Carcinoma Biological Features

This pilot study is designed to evaluate imaging parameters indicative of underlying tumor
biology. Patients with large renal masses (>3 cm, or at the discretion of the investigator)
who are planning to undergo nephrectomy will be identified, and recruited to undergo a
contrast-enhanced magnetic resonance-Fluorodeoxyglucose-positron emission tomography
(MR-FDG-PET) scan.

This pilot study is designed to evaluate imaging parameters indicative of underlying tumor
biology. Patients with large renal masses (>3 cm, or at the discretion of the investigator)
who are planning to undergo nephrectomy will be identified, and recruited to undergo a
contrast-enhanced magnetic resonance-Fluorodeoxyglucose-positron emission tomography
(MR-FDG-PET) scan. Samples collected from their tumor after it is removed will undergo a
variety of laboratory tests, including biomarker assessments and genotyping. By examining
primary renal masses via a combination of MR and FDG-PET functional imaging in concert with
tissue based tests, areas of hypermetabolism and hypervascularization will be evaluated as
features of HIF activation or tumor subtype.

Inclusion Criteria:

- ≥ 18 years of age (no upper age limit)

- Informed consent obtained and signed

- Clinically suspected RCC based on imaging performed prior to enrollment

- Planned nephrectomy schedule that can accommodate a MR-FDG-PET scan within 4 weeks
prior to surgery

- Willing to undergo gadolinium enhanced MRI with simultaneous acquisition of FDG-PET
uptake by the tumor within 4 weeks prior to nephrectomy

- Willing to consent for genetic and proteomic analysis of tumor and germline nucleic
acids

- Women of childbearing potential must have a negative serum or urine pregnancy test
performed within 7 days prior to FDG-PET-MRI

- Breast feeding women cannot do so for 24 hours after FDG injection

- Patient is willing to fast for 4 hours, including avoiding any sugar-containing
drinks.

- Patient is willing to drink at least 32 ounces of water (or other no-sugar-containing
fluids) within 4 hours prior to arriving for scans.

Exclusion Criteria:

- History of severe reaction to gadolinium-enhanced MRI

- Poorly controlled diabetes mellitus

- Inability to tolerate PET and/or MRI

- Presence of pacemaker or intracranial aneurysm clip

- GFR < 30mL/min as measured via Cockcroft-Gault equation

- Inability to lie flat for >1 hour

- Pregnant female

- History of a prior malignancy within past 5 years are excluded unless they have been
disease free for 3 or more years or unless they have a completely resected
non-melanoma skin cancer, low risk prostate cancer, or other low risk tumor history at
the discretion of the investigator.

- Substance abuse, medical, psychological, or social conditions that may interfere with
the patient's participation in the study
We found this trial at
1
site
Chapel Hill, North Carolina 27599
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mi
from
Chapel Hill, NC
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