Kidney Cancer Clinical Trial

Imaging Correlates of Renal Cell Carcinoma Biological Features

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.

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Full 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.

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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

Study is for people with:

Kidney Cancer

Estimated Enrollment:

17

Study ID:

NCT01665703

Recruitment Status:

Completed

Sponsor:

UNC Lineberger Comprehensive Cancer Center

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There is 1 Location for this study

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

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Study is for people with:

Kidney Cancer

Estimated Enrollment:

17

Study ID:

NCT01665703

Recruitment Status:

Completed

Sponsor:


UNC Lineberger Comprehensive Cancer Center

How clear is this clinincal trial information?

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