Head and Neck Cancer Clinical Trial
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
NCT number | NCT01768442 |
Other study ID # | HP-00047152 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 2011 |
Est. completion date | January 2019 |
Verified date | September 2019 |
Source | University of Maryland, Baltimore |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | January 2019 |
Est. primary completion date | September 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 1 Subjects must be 18 years or older. - 2 Subjects must have Stage III or IV head and neck cancer. - 3 Subjects must be undergoing concurrent chemotherapy and radiation with or without induction chemotherapy for head and neck cancers. - 4 Subjects must be capable of giving informed consent. - 5 Subjects must not be claustrophobic. - 6 Patients with conditions or using medications that may contribute to xerostomia will not be excluded in this pilot study, but medical conditions and medications will be documented. - 7 Macroscopic disease at presentation (at least T2 and/or >2cm lymph node) based on radiographic imaging. Exclusion Criteria: - 1 Subjects with pacemakers. - 2 Subjects who have metallic ferromagnetic implants or pumps. - 3 Subjects who are pregnant. Negative serum or urine pregnancy test prior to study entry is required. Once on the protocol, the patient will be advised and expected to implement an accepted and effective method of contraception such as oral contraceptives ('the pill'), intrauterine devices (IUD's), contraceptive implants under skin or contraceptive injections and condoms with foam. - 5 Subjects with kidney disease of any severity or on hemodialysis. - 6 Subjects with known allergies to gadolinium-based contrast agents. - 7 Subjects incapable of lying on their backs for up to an hour at a time. - 8 Subjects who have a tracheostomy. |
Country | Name | City | State |
---|---|---|---|
United States | University of Maryland Medical Center | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
University of Maryland, Baltimore |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Using MR imaging techniques to determine tumor and node response during and post chemoRT | 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. | 16 months | |
Secondary | Predictability of MR imaging techniques during and post chemoRT | 1. 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. | 16 months |
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