Clinical trial NCT01665703: Imaging Correlates of Renal Cell Carcinoma Biological Features
Official title: LCCC 1213: Defining Molecular and Functional Imaging Correlates of Renal Cell Carcinoma Biological Features
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Cell Carcinoma
Keywords: [18F]
Fluorodeoxyglucose Positron Emission Tomography-Magnetic Resonance Imaging
FDG-PET-MRI
Renal Cell Carcinoma
Pilot Study
LCCC 1213
UNC Lineberger
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2012-08-15
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of FDG-PET-MRI making useful measurements that might be then used to globally assess tumor biological features
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: University of North Carolina
name: Weili Lin, PhD
role: PRINCIPAL_INVESTIGATOR
References: