Imaging Correlates of Renal Cell Carcinoma Biological Features

NCT01665703 | Completed DMC

• 1 other identifier: LCCC1213
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Cell Carcinoma

Keywords

[18F]; Fluorodeoxyglucose Positron Emission Tomography-Magnetic Resonance Imaging; FDG-PET-MRI; Renal Cell Carcinoma; Pilot Study; LCCC 1213; UNC Lineberger

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks

Study Arms (1)

FDG PET/MR

EXPERIMENTAL

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

Procedure: FDG PET/MR

Interventions

FDG PET/MR 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.

Also known as: Fluorodeoxyglucose Positron Emission Tomography MRI

FDG PET/MR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

• Lineberger Comprehensive Cancer Center website
• National Cancer Institute (NCI) website

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Weili Lin, PhD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2012
• First Posted: August 15, 2012
• Study Start: August 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: January 1, 2019
• Last Updated: January 7, 2021

Record last verified: 2021-01

Locations

US (1)