Imaging Correlates of Renal Cell Carcinoma Biological Features

This study is currently recruiting participants.
Verified January 2013 by UNC Lineberger Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01665703
First received: August 13, 2012
Last updated: February 1, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Renal Cell Carcinoma
Procedure: FDG-PET-MRI

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: LCCC 1213: Defining Molecular and Functional Imaging Correlates of Renal Cell Carcinoma Biological Features

Resource links provided by NLM:


Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures:
  • Feasibility of FDG-PET-MRI making useful measurements that might be then used to globally assess tumor biological features [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 10
Study Start Date: August 2012
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FDG-PET-MRI Procedure: FDG-PET-MRI
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 Name: Fluorodeoxyglucose Positron Emission Tomography MRI

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01665703

Contacts
Contact: Gayle Grigson, RN (919) 966-4432 gayle_grigson@med.unc.edu
Contact: Dorothy Riguera (919) 843-5420 riguera@email.unc.edu

Locations
United States, North Carolina
Lineberger Comprehensive Cancer Center Recruiting
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
Principal Investigator: Kimryn Rathmell, MD University of North Carolina
  More Information

Additional Information:
No publications provided

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01665703     History of Changes
Other Study ID Numbers: LCCC 1213
Study First Received: August 13, 2012
Last Updated: February 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
[18F]
Fluorodeoxyglucose Positron Emission Tomography-Magnetic Resonance Imaging
FDG-PET-MRI
Renal Cell Carcinoma
Pilot Study
LCCC 1213
UNC Lineberger

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Deoxyglucose
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 21, 2014