Overview

This trial is active, not recruiting.

Condition renal cell carcinoma
Treatment fdg pet/mr
Sponsor UNC Lineberger Comprehensive Cancer Center
Start date August 2012
End date November 2014
Trial size 17 participants
Trial identifier NCT01665703, LCCC1213

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
Participents will undergo a gadolinium enhanced FDG PET/MR study.
fdg pet/mr Fluorodeoxyglucose Positron Emission Tomography 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.

Primary Outcomes

Measure
Feasibility of FDG-PET-MRI making useful measurements that might be then used to globally assess tumor biological features
time frame: 4 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title LCCC 1213: Defining Molecular and Functional Imaging Correlates of Renal Cell Carcinoma Biological Features
Principal investigator Kimryn Rathmell, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center.