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

NCT01768442 | Completed DMC

• 1 other identifier: HP-00047152
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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 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

Head and Neck Cancer

Keywords

Head and neck cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Predictability of MR imaging techniques during and post chemoRT

  16 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

We will recruit patients with locally advanced head and neck cancer into the study. 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.

You may qualify if:

• Subjects must be 18 years or older.
• Subjects must have Stage III or IV head and neck cancer.
• Subjects must be undergoing concurrent chemotherapy and radiation with or without induction chemotherapy for head and neck cancers.
• Subjects must be capable of giving informed consent.
• Subjects must not be claustrophobic.
• 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.
• Macroscopic disease at presentation (at least T2 and/or \>2cm lymph node) based on radiographic imaging.

You may not qualify if:

• Subjects with pacemakers.
• Subjects who have metallic ferromagnetic implants or pumps.
• 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.
• Subjects with kidney disease of any severity or on hemodialysis.
• Subjects with known allergies to gadolinium-based contrast agents.
• Subjects incapable of lying on their backs for up to an hour at a time.
• Subjects who have a tracheostomy.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Warren D'Souza, PhD

  University of Maryland Dept. of Radiation Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 9, 2013
• First Posted: January 15, 2013
• Study Start: September 1, 2011
• Primary Completion: September 1, 2018
• Study Completion: January 1, 2019
• Last Updated: September 12, 2019

Record last verified: 2019-09

Locations

US (1)