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NCT01768442 · ClinicalTrials.gov registry record

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

A clinical trial of Head and Neck Cancer, sponsored by University of Maryland, Baltimore.

Completed
Registry status
30
Enrollment target
1
Study location

NCT01768442 is a study of Head and Neck Cancer that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 30 participants, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01768442, a study of Head and Neck Cancer, has completed, sponsored by University of Maryland, Baltimore.

COMPLETED
Registry status
30 participants
Enrollment target
1
Study location

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 Studied

Study Locations (1)

Maryland

  • University of Maryland Medical Center - Baltimore

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2011-09
Est. Completion 2019-01

Sponsor

University of Maryland, Baltimore

560 total trials

What the Registry Record Tells You About NCT01768442

The ClinicalTrials.gov registry entry for NCT01768442 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (89% lower). The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Head and Neck Cancer appearing as the primary indexed condition, and to 0 interventions.

NCT01768442 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT01768442 about?

NCT01768442 is a clinical study titled "MRI for Eval Tumor & Node Response & Normal Tissue Function to Concurrent Chemo & Radiation Therapy in H&N Cancer (GCC1043)". 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, biochemi...

What is the current status of trial NCT01768442?

This trial is currently completed. The enrollment target is 30 participants. The study started on 2011-09. Estimated completion is 2019-01.

What conditions does trial NCT01768442 study?

This clinical trial studies the following conditions: Head and Neck Cancer.

Who is sponsoring clinical trial NCT01768442?

This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01768442 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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