Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04831138
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-25
First Post:
2021-03-31
Brief Title:
Non-Contrast Perfusion Using Arterial Spin Labeled MR Imaging for Assessment of Therapy Response in Metastatic Renal Cell Carcinoma
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
A Prospective Study to Evaluate Quantitative Non-Contrast Perfusion Using Arterial Spin Labeled MR Imaging for Assessment of Therapy Response in Metastatic Renal Cell Carcinoma
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Magnetic Resonance Imaging MRI including Arterial Spin Labeling ASL will be performed before during and after the treatment in a total of up to 6 MRI sessions until 7 months after the first session or when progression is clinically indicated Thereafter patients will be followed through standard clinical examinations for the next 3 years or until demise whichever occurs first
Clinically metastatic renal cell carcinoma RCC patients are imaged every 2-3 months after the initiation of anti-angiogenic therapy since morphological ie size changes are not anticipated earlier However our preliminary experience has shown functional changes including perfusion as early as 2-weeks after the initiation of the treatment T0 T1 and T2 sessions will be performed for this proposal while T3 T4 and T5 will be performed along with the clinical imaging sessions All MR imaging sessions will be scheduled within 1 or 2 weeks of the target time period
The research MR imaging may take approximately an additional 15 minutes per each imaging session when done in conjunction with the clinical imaging The T0 T1 and T2 research MR imaging sessions will be performed additionally for the purpose of this study with each taking approximately one hour
Clinically metastatic renal cell carcinoma RCC patients are imaged every 2-3 months after the initiation of anti-angiogenic therapy since morphological ie size changes are not anticipated earlier However our preliminary experience has shown functional changes including perfusion as early as 2-weeks after the initiation of the treatment T0 T1 and T2 sessions will be performed for this proposal while T3 T4 and T5 will be performed along with the clinical imaging sessions All MR imaging sessions will be scheduled within 1 or 2 weeks of the target time period
The research MR imaging may take approximately an additional 15 minutes per each imaging session when done in conjunction with the clinical imaging The T0 T1 and T2 research MR imaging sessions will be performed additionally for the purpose of this study with each taking approximately one hour
Detailed Description:
The incidence of kidney cancer has steadily increased over the past three to four decades and is among the 10 most frequently diagnosed cancers in the US Approximately 63990 new cases of kidney cancer are estimated in 2017 and the prognosis has been historically poor The current 5-year survival rates are estimated at 74 overall decreasing to 53 among patients with locally advanced diseases
The most common form of kidney cancer renal cell carcinoma RCC occurs in 90 of all kidney cancers Among patients with localized RCC who are treated with nephrectomy approximately one quarter have relapses in distant sites Among patients with metastatic RCC the 5-year survival rates are approximately 8 With better understanding of the pathogenesis of the most common type of RCC clear-cell renal cell carcinoma ccRCC newer treatment options with new agents are being developed to increase survival rates
The high cost and potential risks associated with human trials for the newly developed experimental therapies have emphasized the need for sensitive monitoring of tumor response Imaging approaches can play an important role in the evaluation and selection of potential new therapies with non-invasive longitudinal monitoring of treatment response Currently the radiological assessment of treatment outcomes predominantly relies on morphological ie size changes using the Response Evaluation Criteria in Solid Tumors RECIST and other similar scores This is a major limiting factor as the effects of many therapeutic agents at the microscopic level precede the eventual changes in tumor size One such tumor property that has gained increased attention is angiogenesis which has been shown to support tumor proliferation and infiltration Increasing numbers of clinical trials have begun targeting tumor vascular supplies by directly inhibiting angiogenesis eg antiangiogenic therapy Such clinical trials and the eventual clinical use of these therapies would be greatly assisted by the availability of robust imaging indicators of angiogenesis ie tissue perfusion
Positron Emission Tomography PET using 15O-labeled water 15O-PET is considered the gold standard for non-invasive measurement of tissue perfusion However the use of 15O-PET requires a cyclotron in close proximity to PET to produce short lived 15O-water half life 24 min limiting its applicability in clinical settings Alternative imaging techniques include ultrasound using microbubbles perfusion computed tomography CT using iodinated contrast agent and perfusion MRI using gadolinium based contrast agents All of these techniques require exogenous agents restricting their use in longitudinal monitoring of treatment response
ASL-MRI has recently emerged as a quantitative imaging QI method to measure perfusion or capillary blood flow without the administration of exogenous contrast agents ASL magnetically labels the highly permeable water in the blood as a tracer and measures their accumulation in the tissue of interest without injecting any exogeneous contrast Various versions of ASL have been validated in animals using microspheres and in humans using 15O-PET in the brain ASL also has a number of advantages compared to dynamic contrast enhanced DCE and dynamic susceptibility contrast DSC based MR perfusion measurements Specifically ASL does not require exogenous agent alleviating the concerns of gadolinium accumulation or nephrogenic systemic fibrosis NSF in patients with impaired renal function and unlike DCEDSC the contribution of vascular permeability to ASL measured perfusion is negligible enabling absolute perfusion quantification in physiological units
The most common form of kidney cancer renal cell carcinoma RCC occurs in 90 of all kidney cancers Among patients with localized RCC who are treated with nephrectomy approximately one quarter have relapses in distant sites Among patients with metastatic RCC the 5-year survival rates are approximately 8 With better understanding of the pathogenesis of the most common type of RCC clear-cell renal cell carcinoma ccRCC newer treatment options with new agents are being developed to increase survival rates
The high cost and potential risks associated with human trials for the newly developed experimental therapies have emphasized the need for sensitive monitoring of tumor response Imaging approaches can play an important role in the evaluation and selection of potential new therapies with non-invasive longitudinal monitoring of treatment response Currently the radiological assessment of treatment outcomes predominantly relies on morphological ie size changes using the Response Evaluation Criteria in Solid Tumors RECIST and other similar scores This is a major limiting factor as the effects of many therapeutic agents at the microscopic level precede the eventual changes in tumor size One such tumor property that has gained increased attention is angiogenesis which has been shown to support tumor proliferation and infiltration Increasing numbers of clinical trials have begun targeting tumor vascular supplies by directly inhibiting angiogenesis eg antiangiogenic therapy Such clinical trials and the eventual clinical use of these therapies would be greatly assisted by the availability of robust imaging indicators of angiogenesis ie tissue perfusion
Positron Emission Tomography PET using 15O-labeled water 15O-PET is considered the gold standard for non-invasive measurement of tissue perfusion However the use of 15O-PET requires a cyclotron in close proximity to PET to produce short lived 15O-water half life 24 min limiting its applicability in clinical settings Alternative imaging techniques include ultrasound using microbubbles perfusion computed tomography CT using iodinated contrast agent and perfusion MRI using gadolinium based contrast agents All of these techniques require exogenous agents restricting their use in longitudinal monitoring of treatment response
ASL-MRI has recently emerged as a quantitative imaging QI method to measure perfusion or capillary blood flow without the administration of exogenous contrast agents ASL magnetically labels the highly permeable water in the blood as a tracer and measures their accumulation in the tissue of interest without injecting any exogeneous contrast Various versions of ASL have been validated in animals using microspheres and in humans using 15O-PET in the brain ASL also has a number of advantages compared to dynamic contrast enhanced DCE and dynamic susceptibility contrast DSC based MR perfusion measurements Specifically ASL does not require exogenous agent alleviating the concerns of gadolinium accumulation or nephrogenic systemic fibrosis NSF in patients with impaired renal function and unlike DCEDSC the contribution of vascular permeability to ASL measured perfusion is negligible enabling absolute perfusion quantification in physiological units
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None