Parametric PET of Renal Cell Carcinoma
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|ClinicalTrials.gov Identifier: NCT04020978|
Recruitment Status : Recruiting
First Posted : July 16, 2019
Last Update Posted : September 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Renal Cell Carcinoma||Diagnostic Test: Parametric PET/CT||Not Applicable|
Renal cell carcinoma (RCC) is one of the top ten cancer types in the US. One-third of RCCs are metastatic and associated with a poor 5-year survival rate of 8%. Metastatic RCC is usually treated with targeted therapy or immunotherapy which is costly (>$10,000 per month) and has low response rate (<30%). Effective identification of the most appropriate drugs for a patient relies on noninvasive imaging to assess early response to the drugs. However, current practice by anatomical imaging such as computed tomography (CT) or magnetic resonance imaging (MRI) can only assess the response at two months after initialing targeted therapy. This approach exposes many patients to highly toxic, high expensive treatment without any benefit for months and delays initiation of other effective therapies.
The investigators hypothesize that functional perfusion imaging by positron emission tomography (PET) can enable RCC response assessment as early as at 1-2 weeks given that RCC is highly related to angiogenesis and most targeted drugs for RCC are antiangiogenic. However, clinical options for functional renal imaging are very limited. While dynamic contrast-enhanced CT or MRI can be used for perfusion imaging, their use is restricted because 30% of RCC patients have chronic kidney diseases with renal dysfunction and are at higher risk for contrast-induced nephropathy and nephrogenic systemic fibrosis. Existing PET radiotracers (e.g., 15O-water) for perfusion imaging are short-lived and generally unavailable for clinical use. This project explores parametric PET perfusion imaging using the widely accessible 18F-fluorodeoxyglucose (FDG). 18F-FDG PET is conventionally used for metabolic imaging and has been rarely used for imaging kidneys because physiological excretion of 18F-FDG into renal pelvis contaminates image quality for renal tumor assessment. The investigators explore the potential of the metabolic radiotracer 18F-FDG for perfusion imaging by employing four-dimensional (4D: 3D space plus 1D time) dynamic scanning and tracer kinetic modeling, leading to parametric imaging of FDG perfusion kinetics without being affected by 18F-FDG excretion. The parametric PET method can potentially identify RCC response and assess drug efficacy with 1-2 weeks of treatment as compared to 2 months by current anatomical imaging methods.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study Using Parametric PET to Assess Early Treatment Response to Targeted Therapy for Renal Cell Carcinoma|
|Actual Study Start Date :||July 16, 2019|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||May 2021|
Patients with Renal Cell Carcinoma
Each patient with metastatic renal cell carcinoma will first undergo an X-ray CT scan for attenuation correction purpose. After that, 10 mCi 18F-Fludeoxyglucose (18F-FDG) will be injected into the patient through the IV in a period of 10 seconds. The PET scan commences 10 seconds before the FDG injection and lasts for 60 minutes. After the PET scan, the patient gets off the scanner. One blood sample (10cc) will be drawn using a butterfly method with the time recorded.
Diagnostic Test: Parametric PET/CT
Each patient will undergo a dynamic F18-FDG PET/CT scan at baseline and 2-week post therapy.
- Changes in blood flow [ Time Frame: Two weeks ]Tumor blood flow in the unit of mL/min/g will be derived from early-dynamic FDG-PET with tracer kinetic modeling. The change between baseline and follow-up scans will be calculated.
- Changes in blood volume [ Time Frame: Two weeks ]Tumor blood volume fraction in percentage will be derived from early-dynamic FDG-PET with tracer kinetic modeling. The change between baseline and follow-up scans will be calculated.
- Correlation with tumor anatomical response [ Time Frame: Two months ]Correlation between the functional changes measured by parametric PET/CT at two weeks with anatomical size change measured by standard CT or MRI at two months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04020978
|Contact: John M Brockemail@example.com|
|United States, California|
|UC Davis Medical Center||Recruiting|
|Sacramento, California, United States, 95817|
|Contact: John Brock firstname.lastname@example.org|
|Contact: Ghizala Safi email@example.com|
|Principal Investigator: Chong-xian Pan, MD|
|Principal Investigator: Guobao Wang, PhD|
|Sub-Investigator: Lorenzo Nardo, MD|
|Sub-Investigator: Rosalie Hagge, MD|
|Sub-Investigator: Ramsey Badawi, PhD|
|Sub-Investigator: Michael Corwin, MD|