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

18 Years
Open (Enrolling)
Renal Cell Carcinoma

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Trial Information

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. 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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Feasibility of FDG-PET-MRI making useful measurements that might be then used to globally assess tumor biological features

Outcome Description:

This is a feasibility study. Feasibility will be determined by the quality of the FDG-PET-MRI measurements. That is, the measurements represent what the investigators hope they are measuring. With 10 of 10, the 100% rate has an exact 95% confidence interval of 69% to 100%. The interval width, representing a measure of precision, is 31%. The tumor biological features that will be assessed include genetic analyses performed for commonly mutated genes in kidney cancer (VHL, PBRM1, SETD2, HIF1, UTX, MLL2) and protein expression analyses performed on HIF1 and HIF2 protein expression using standard immunohistochemistry. These genetic and protein expression analyses will be performed on tissue samples collected within four weeks of imaging from tissue removed via nephrectomy.

Outcome Time Frame:

4 weeks

Safety Issue:


Principal Investigator

Kimryn Rathmell, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of North Carolina


United States: Institutional Review Board

Study ID:

LCCC 1213



Start Date:

August 2012

Completion Date:

August 2019

Related Keywords:

  • Renal Cell Carcinoma
  • [18F]
  • Fluorodeoxyglucose Positron Emission Tomography-Magnetic Resonance Imaging
  • Renal Cell Carcinoma
  • Pilot Study
  • LCCC 1213
  • UNC Lineberger
  • Carcinoma
  • Carcinoma, Renal Cell



Lineberger Comprehensive Cancer CenterChapel Hill, North Carolina  27599-7305