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Imaging Correlates of Renal Cell Carcinoma Biological Features

Primary Purpose

Renal Cell Carcinoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FDG PET/MR
Sponsored by
UNC Lineberger Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Renal Cell Carcinoma focused on measuring [18F], Fluorodeoxyglucose Positron Emission Tomography-Magnetic Resonance Imaging, FDG-PET-MRI, Renal Cell Carcinoma, Pilot Study, LCCC 1213, UNC Lineberger

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Lineberger Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FDG PET/MR

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 13, 2012
Last Updated
January 6, 2021
Sponsor
UNC Lineberger Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01665703
Brief Title
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

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
January 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNC Lineberger Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
Keywords
[18F], Fluorodeoxyglucose Positron Emission Tomography-Magnetic Resonance Imaging, FDG-PET-MRI, Renal Cell Carcinoma, Pilot Study, LCCC 1213, UNC Lineberger

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FDG PET/MR
Arm Type
Experimental
Arm Description
Participents will undergo a gadolinium enhanced FDG PET/MR study.
Intervention Type
Procedure
Intervention Name(s)
FDG PET/MR
Other Intervention Name(s)
Fluorodeoxyglucose Positron Emission Tomography MRI
Intervention Description
Patients will be asked to undergo a voluntary gadolinium enhanced MRI with simultaneous acquisition of FDG-PET uptake within 4 weeks prior to surgery.
Primary Outcome Measure Information:
Title
Feasibility of FDG-PET-MRI making useful measurements that might be then used to globally assess tumor biological features
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weili Lin, PhD
Organizational Affiliation
University of North Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lineberger Comprehensive Cancer Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Links:
URL
http://unclineberger.org/
Description
Lineberger Comprehensive Cancer Center website
URL
http://www.cancer.gov/
Description
National Cancer Institute (NCI) website

Learn more about this trial

Imaging Correlates of Renal Cell Carcinoma Biological Features

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