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MRI for Eval Tumor & Node Response & Normal Tissue Function to Concurrent Chemo & Radiation Therapy in H&N Cancer (GCC1043)

NCT01768442 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2019-09-12

No results posted yet for this study

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 subject's 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.

Conditions

Sponsors & Collaborators

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Warren D'Souza, PhD · University of Maryland Dept. of Radiation Oncology

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2018-09-30
Completion
2019-01-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01768442 on ClinicalTrials.gov