Imaging Correlates of Renal Cell Carcinoma Biological Features
This trial is active, not recruiting.
|Condition||renal cell carcinoma|
|Sponsor||UNC Lineberger Comprehensive Cancer Center|
|Start date||August 2012|
|End date||November 2014|
|Trial size||17 participants|
|Trial identifier||NCT01665703, LCCC1213|
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.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
Feasibility of FDG-PET-MRI making useful measurements that might be then used to globally assess tumor biological features
time frame: 4 weeks
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
|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.|
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