Ignite Creation Date:
2024-05-06 @ 1:14 AM
Last Modification Date:
2024-10-26 @ 11:01 AM
Study NCT ID:
NCT01768442
Status:
COMPLETED
Last Update Posted:
2019-09-12
First Post:
2013-01-09
Brief Title:
MRI for Eval Tumor Node Response Normal Tissue Function to Concurrent Chemo Radiation Therapy in HN Cancer GCC1043
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
GCC1043 Magnetic Resonance Imaging for Evaluating Tumor and Node Response and Normal Tissue Function to Concurrent Chemotherapy and Radiation Therapy in Head and Neck Cancer
Status:
COMPLETED
Status Verified Date:
2019-09
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:
The investigators goal is to incorporate advanced imaging information into the treatment planning process and assess response in tumor nodes and non-cancerous tissues in head and neck cancer patients during and after concurrent chemotherapy and radiation therapy chemoRT via biophysical biochemical and vascular imaging using magnetic resonance imaging MRI The investigators will recruit 30 patients with locally advanced head and neck cancer into the study All patients will obtain an advanced MRI study at three time points 1 before the start of chemoRT 2 4 weeks following the start of chemoRT and 3 3-4 months following completion of chemoRT MRI scans will include a T1 T2 and T2 imaging b vascular images using dynamic contrast enhanced DCE imaging c biophysical microstructure images using diffusion-weighted imaging and d biochemical images using MR spectroscopic imaging The subjects response tumor nodes and salivary and mucosal tissues will be evaluated using clinical outcomes Correlations will be generated between the parameters obtained from MR images and from clinical response assessments
The purpose of this study is to assess whether advanced MR imaging techniques can be used to determine tumor and node response i four weeks following initiation of concurrent chemoRT and ii after completion of chemoRT in head and neck cancer and to assess whether advanced MR imaging techniques can be used to predict early at-risk organ function salivary gland and mucosal injury as measured by salivary flow and oral mucositis to chemoradiation therapy i four weeks following initiation of concurrent chemoRT and ii after completion of chemoRT in head and neck cancer
The purpose of this study is to assess whether advanced MR imaging techniques can be used to determine tumor and node response i four weeks following initiation of concurrent chemoRT and ii after completion of chemoRT in head and neck cancer and to assess whether advanced MR imaging techniques can be used to predict early at-risk organ function salivary gland and mucosal injury as measured by salivary flow and oral mucositis to chemoradiation therapy i four weeks following initiation of concurrent chemoRT and ii after completion of chemoRT in head and neck cancer
Detailed Description:
MRI scans will be performed at three time points The time points will be 1-2 weeks prior to the start of treatment between 4 and 5 weeks after the start of treatment ie after the 20th radiation treatment fraction and before the start of the 25th radiation treatment fraction and 3-4 months after the completion of chemoRT Scans acquired at the first and third time points will be clinically indicated except for the spectroscopy scan and ordered by the treating physician The scan session corresponding to the second time point will be for research purposes The investigators chose 4-5 weeks as the time point for predicting early response to chemoRT for the following reason In a 7-week treatment regimen an indicator tested at 5 weeks would have limited predictive utility in the consideration of an alternative therapy ie surgical intervention However an indicator measured at 5 weeks ie with enough time remaining to the end of therapy might potentially inform the therapeutic course of action in future studies If this pilot study demonstrates utility of advanced MR imaging techniques identified at 4-5 weeks future studies could focus on the optimal timing for assessment of early response The time point of 3-4 months is selected for assessing post-therapy response because it coincides with the clinical follow-up schedule at which an image-based assessment of response is performed via a clinical exam andor PET imaging that determines the standard of care response
T1 T2 and T2 MRI scans will be performed to delineate head and neck tissues DCE MRI scans will provide quantitative assessment of contrast uptake in tissues and tissue vasculature both during and at follow-up after completion of chemoRT Contrast on images will be provided by a gadolinium-based contrast agent GBCA GBCA is FDA-approved and is routinely used in dynamic contrast-enhanced MRI scans Further contrast enhanced MRI is typically obtained on all cancer patients including head and neck cancer as part of routine clinical care Diffusion MRI scans will provide information on the diffusion of water molecules in tumor nodes and other head and neck tissues MR spectroscopy scans will provide information on tissue metabolites All scans acquired prior to the start of chemoRT will provide baseline maps against which functional maps acquired during and after completion of chemoRT will be compared to determine the relative change in anatomical biophysical and biochemical parameters
Image anatomy and parameter maps will be correlated with dose maps derived from CT images by registering fusing MRI images with CT images acquired as part of standard of care and used for treatment planning of the subjects radiation treatment
T1 T2 and T2 MRI scans will be performed to delineate head and neck tissues DCE MRI scans will provide quantitative assessment of contrast uptake in tissues and tissue vasculature both during and at follow-up after completion of chemoRT Contrast on images will be provided by a gadolinium-based contrast agent GBCA GBCA is FDA-approved and is routinely used in dynamic contrast-enhanced MRI scans Further contrast enhanced MRI is typically obtained on all cancer patients including head and neck cancer as part of routine clinical care Diffusion MRI scans will provide information on the diffusion of water molecules in tumor nodes and other head and neck tissues MR spectroscopy scans will provide information on tissue metabolites All scans acquired prior to the start of chemoRT will provide baseline maps against which functional maps acquired during and after completion of chemoRT will be compared to determine the relative change in anatomical biophysical and biochemical parameters
Image anatomy and parameter maps will be correlated with dose maps derived from CT images by registering fusing MRI images with CT images acquired as part of standard of care and used for treatment planning of the subjects radiation treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None