Clinical Trials Logo

Clinical Trial Summary

Metastatic kidney cancer is usually treated with targeted therapy or immunotherapy which is costly and has low response rate. The current standard care is to perform anatomical imaging studies after a few cycles (months) of treatment to evaluate response. This approach exposes many patients to highly toxic, high expensive treatment without any benefit for months and delays initiation of other effective therapies. The goal of this study is to evaluate a parametric PET method that potentially identify response and assess drug efficacy with a few days to weeks of treatment.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT04020978
Study type Interventional
Source University of California, Davis
Contact
Status Active, not recruiting
Phase N/A
Start date July 16, 2019
Completion date February 2024

See also
  Status Clinical Trial Phase
Completed NCT02222259 - A Feasibility Trial of Geriatric Assessment and Management for Older Cancer Patients N/A
Recruiting NCT04923178 - A Multi-Center Natural History of Urothelial Cancer and Rare Genitourinary Tract Malignancies
Enrolling by invitation NCT05629065 - Pathways to Advance Targeted and Helpful Serious Illness Conversations (PATH-SIC) N/A
Recruiting NCT03740503 - Genomic Investigation of Unusual Responders
Recruiting NCT05837598 - Adapting the Tumor Board Model for Mental Illness and Cancer N/A
Recruiting NCT04354064 - Circulating Tumor DNA (ctDNA) for Early Treatment Response Assessment of Solid Tumors
Active, not recruiting NCT02735252 - PROMOTE: Identifying Predictive Markers of Response for Genitourinary Cancer N/A
Terminated NCT03480152 - Messenger RNA (mRNA)-Based, Personalized Cancer Vaccine Against Neoantigens Expressed by the Autologous Cancer Phase 1/Phase 2
Recruiting NCT06253520 - Autologous T-cells Genetically Engineered to Express Receptors Reactive Against KRAS Mutations in Conjunction With a Vaccine Directed Against These Antigens in Participants With Metastatic Cancer Phase 1
Completed NCT01433302 - Inflammatory Response and Tissue Fibrosis/ Lymphatico-venous Bypass N/A
Recruiting NCT04273061 - Investigating the Effects of Atezolizumab in People Whose Tumour DNA or RNA Indicates Possible Sensitivity Phase 2
Completed NCT03887091 - Personal Web Page In Clinical Trial Participant Education N/A
Terminated NCT00147238 - A Validation Study of MR Lymphangiography Using SPIO, a New Lymphotropic Superparamagnetic Nanoparticle Contrast N/A
Recruiting NCT04235777 - Bintrafusp Alfa (M7824) and NHS-IL12 (M9241) Alone and in Combination With Stereotactic Body Radiation Therapy (SBRT) in Adults With Metastatic Non-Prostate Genitourinary Malignancies Phase 1
Active, not recruiting NCT06168825 - Mind Over Matter for Black and African American Women: A Single Arm Trial Examining Feasibility and Acceptability of a Supportive Intervention
Completed NCT02140463 - Next Generation pErsonalized tX(Therapy) With Plasma DNA Trial-2 in Refractory Solid Tumors (The NEXT-2 Trial)
Active, not recruiting NCT01505400 - Integrated Molecular Profiling in Advanced Cancers Trial
Recruiting NCT04761107 - Impact of COVID-19 on GU Disease
Active, not recruiting NCT03333616 - Nivolumab Combined With Ipilimumab for Patients With Advanced Rare Genitourinary Tumors Phase 2
Active, not recruiting NCT03794635 - An Intervention to Help Patients and Caregivers Manage Stress and Improve Communication Skills When Talking About Cancer N/A