Imaging Correlates of Renal Cell Carcinoma Biological Features

Sponsor

UNC Lineberger Comprehensive Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT01665703

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Renal Cell Carcinoma	Procedure: FDG PET/MR	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

17 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Aug 1, 2012

Actual Primary Completion Date :

Nov 1, 2014

Actual Study Completion Date :

Jan 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FDG PET/MR Participents will undergo a gadolinium enhanced FDG PET/MR study.	Procedure: FDG PET/MR Patients will be asked to undergo a voluntary gadolinium enhanced MRI with simultaneous acquisition of FDG-PET uptake within 4 weeks prior to surgery. Other Names: Fluorodeoxyglucose Positron Emission Tomography MRI

Arm

Intervention/Treatment

Experimental: FDG PET/MR

Participents will undergo a gadolinium enhanced FDG PET/MR study.

Procedure: FDG PET/MR

Patients will be asked to undergo a voluntary gadolinium enhanced MRI with simultaneous acquisition of FDG-PET uptake within 4 weeks prior to surgery.

Other Names:

Fluorodeoxyglucose Positron Emission Tomography MRI

Outcome Measures

Primary Outcome Measures

Feasibility of FDG-PET-MRI making useful measurements that might be then used to globally assess tumor biological features [4 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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