Imaging Correlates of Renal Cell Carcinoma Biological Features

NCT ID: NCT01665703

Last Updated: 2021-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2019-01-31

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.

Conditions

Renal Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

FDG PET/MR

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

Group Type: EXPERIMENTAL

FDG PET/MR

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

Fluorodeoxyglucose Positron Emission Tomography MRI

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Weili Lin, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Locations

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Countries

United States

Related Links

http://unclineberger.org/

Lineberger Comprehensive Cancer Center website

http://www.cancer.gov/

National Cancer Institute (NCI) website

Other Identifiers

LCCC1213

Identifier Type: -

Identifier Source: org_study_id