MRI Mapping in Planning Radiation Therapy to the Base of Skull and Brain in Patients With Nonmetastatic Head and Neck Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Abramson Cancer Center of the University of Pennsylvania
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00984074
First received: September 23, 2009
Last updated: February 24, 2011
Last verified: September 2009
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Purpose
RATIONALE: Diagnostic procedures, such as specialized types of magnetic resonance imaging (MRI), may help in planning radiation therapy that does less damage to normal tissues.
PURPOSE: This phase I trial is studying using functional MRI to see how well it works in planning radiation therapy in patients undergoing radiation therapy to the base of the skull and/or brain for nonmetastatic head and neck cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer |
Procedure: blood-oxygen-level-dependent functional magnetic resonance imaging Procedure: diffusion tensor imaging Procedure: dynamic contrast-enhanced magnetic resonance imaging Procedure: functional magnetic resonance imaging Radiation: intensity-modulated radiation therapy Radiation: radiation therapy treatment planning/simulation |
Phase 1 |
| Study Type: | Observational |
| Official Title: | A Pilot Study of Functional Mapping and Brain Perfusion Imaging in Patients Receiving Base of Skull and Brain Radiotherapy: Developing Neurocognitive Functional Organs At Risk for Individualized Conformal Radiotherapy |
Resource links provided by NLM:
MedlinePlus related topics:
Benign Tumors
Cancer
Head and Neck Cancer
MRI Scans
Tonsils and Adenoids
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Feasability, as assessed by the proportion of study patients with functional regions identified within the brain as receiving exit irradiation [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Summary parameters of the dose volume histograms to the functional regions identified [ Designated as safety issue: No ]
- Cerebral blood flow and blood volume quantitated by relative measures normalized to regions of the brain not receiving any irradiation [ Designated as safety issue: No ]
| Estimated Enrollment: | 6 |
| Study Start Date: | October 2008 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- To determine the feasibility of applying established MRI techniques to map functional anatomic regions at potential risk in irradiated normal brain tissue of patients undergoing radiotherapy to the base of the skull and brain for head and neck neoplasms.
- To determine changes in cerebral blood flow and blood volume with perfusion MRI techniques in irradiated regions of the brain as a function of the radiation dose.
OUTLINE: Patients undergo MRI perfusion imaging and functional (fMRI) (standard structural imaging sequences, diffusion tensor imaging, arterial spin labeled perfusion imaging at rest, blood oxygen level dependent, and dynamic susceptibility contrast perfusion weighted MRI) at baseline and 3 and 6 months after completion of radiotherapy. Patients may perform tasks for fMRI studies, including finger tapping, photic stimulation with a flashing light, solving math problems, comparing shapes, giving a speech, or listening to and reciting lists of words during fMRI image acquisition. Patients also undergo daily fractionated intensity-modulated radiotherapy.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed head and neck cancer that requires radiotherapy to the base of the skull
- No evidence of metastatic disease
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy ≥ 1 year
- Not pregnant
- Negative pregnancy test
- Able to undergo standard CT simulation and radiotherapy treatment planning and delivery, including the capacity to comply with standard immobilization devices to the head and neck for daily irradiation
- Able to undergo standard MRI and deemed capable of complying with the immobilization needs and tasks required for functional MRIs
- No claustrophobia
- No patients with pacemakers, metal fragments in the eye, or certain metallic implants
PRIOR CONCURRENT THERAPY:
- Not specified
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00984074
Locations
| United States, Pennsylvania | |
| Abramson Cancer Center of the University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104-4283 | |
| Contact: Clinical Trials Office - Abramson Cancer Center of the Univers 800-474-9892 | |
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
| Principal Investigator: | Harry Quon, MD | Abramson Cancer Center of the University of Pennsylvania |
| Investigator: | Michael Mehler | Abramson Cancer Center of the University of Pennsylvania |
More Information
Additional Information:
No publications provided
| Responsible Party: | Stephen Michael Hahn, Abramson Cancer Center of the University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT00984074 History of Changes |
| Other Study ID Numbers: | CDR0000654169, UPCC-808258 |
| Study First Received: | September 23, 2009 |
| Last Updated: | February 24, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
recurrent squamous cell carcinoma of the hypopharynx stage I squamous cell carcinoma of the hypopharynx stage II squamous cell carcinoma of the hypopharynx stage III squamous cell carcinoma of the hypopharynx recurrent squamous cell carcinoma of the larynx recurrent verrucous carcinoma of the larynx stage I squamous cell carcinoma of the larynx stage I verrucous carcinoma of the larynx stage II squamous cell carcinoma of the larynx stage II verrucous carcinoma of the larynx stage III squamous cell carcinoma of the larynx stage III verrucous carcinoma of the larynx recurrent adenoid cystic carcinoma of the oral cavity recurrent mucoepidermoid carcinoma of the oral cavity recurrent verrucous carcinoma of the oral cavity |
stage I adenoid cystic carcinoma of the oral cavity stage I mucoepidermoid carcinoma of the oral cavity stage I verrucous carcinoma of the oral cavity stage II adenoid cystic carcinoma of the oral cavity stage II mucoepidermoid carcinoma of the oral cavity stage II verrucous carcinoma of the oral cavity stage III adenoid cystic carcinoma of the oral cavity stage III mucoepidermoid carcinoma of the oral cavity stage III verrucous carcinoma of the oral cavity stage I squamous cell carcinoma of the lip and oral cavity stage II squamous cell carcinoma of the lip and oral cavity stage III squamous cell carcinoma of the lip and oral cavity recurrent basal cell carcinoma of the lip recurrent squamous cell carcinoma of the lip and oral cavity stage I basal cell carcinoma of the lip |
Additional relevant MeSH terms:
|
Head and Neck Neoplasms Neoplasms by Site Neoplasms |
ClinicalTrials.gov processed this record on June 18, 2013