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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

18 Years
Open (Enrolling)
Head and Neck Cancer

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Trial Information

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

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 (i.e., 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, i.e., surgical intervention. However, an indicator
measured at <= 5 weeks (i.e., 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 and/or 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 subject's radiation treatment.

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.

Type of Study:


Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Using MR imaging techniques to determine tumor and node response during and post chemoRT

Outcome Description:

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.

Outcome Time Frame:

16 months

Safety Issue:


Principal Investigator

Warren D'Souza, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Maryland Dept. of Radiation Oncology


United States: Institutional Review Board

Study ID:




Start Date:

September 2011

Completion Date:

December 2013

Related Keywords:

  • Head and Neck Cancer
  • Head and neck cancer
  • Head and Neck Neoplasms



University of Maryland Medical CenterBaltimore, Maryland  21201-1595