Imaging Correlates of Renal Cell Carcinoma Biological Features

January 6, 2021 updated by: UNC Lineberger Comprehensive Cancer Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Lineberger Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of FDG-PET-MRI making useful measurements that might be then used to globally assess tumor biological features
Time Frame: 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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNC Lineberger Comprehensive Cancer Center

Investigators

  • Principal Investigator: Weili Lin, PhD, University of North Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

August 13, 2012

First Submitted That Met QC Criteria

August 13, 2012

First Posted (Estimate)

August 15, 2012

Study Record Updates

Last Update Posted (Actual)

January 7, 2021

Last Update Submitted That Met QC Criteria

January 6, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCCC1213

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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