MRI Mapping in Planning Radiation Therapy to the Base of... | NCT00984074 | Trialant
NCT00984074
Sponsor
Abramson Cancer Center at Penn Medicine
Status
Completed
Last Update Posted
Apr 24, 2019Actual
Enrollment
3Actual
Phase
Not provided
Conditions
Head and Neck Cancer
Interventions
blood-oxygen-level-dependent functional magnetic resonance imaging
diffusion tensor imaging
dynamic contrast-enhanced magnetic resonance imaging
functional magnetic resonance imaging
intensity-modulated radiation therapy
radiation therapy treatment planning/simulation
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00984074
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CDR0000654169
Secondary IDs
ID
Type
Description
Link
808258
Brief Title
MRI Mapping in Planning Radiation Therapy to the Base of Skull and Brain in Patients With Nonmetastatic Head and Neck Cancer
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
Acronym
Not provided
Organization
Abramson Cancer Center at Penn MedicineOTHER
Status Module
Record Verification Date
Apr 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 2008Actual
Primary Completion Date
Dec 2011Actual
Completion Date
Dec 2011Actual
First Submitted Date
Sep 23, 2009
First Submission Date that Met QC Criteria
Sep 23, 2009
First Posted Date
Sep 24, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 22, 2019
Last Update Posted Date
Apr 24, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Abramson Cancer Center at Penn MedicineOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
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.
Detailed Description
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.
Conditions Module
Conditions
Head and Neck Cancer
Keywords
stage III salivary gland cancer
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
Design Module
Study Type
Observational
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Not provided
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
3Actual
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
blood-oxygen-level-dependent functional magnetic resonance imaging
Procedure
diffusion tensor imaging
Procedure
dynamic contrast-enhanced magnetic resonance imaging
Procedure
functional magnetic resonance imaging
Procedure
intensity-modulated radiation therapy
Radiation
radiation therapy treatment planning/simulation
Radiation
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Feasability, as assessed by the proportion of study patients with functional regions identified within the brain as receiving exit irradiation
90 days
Secondary Outcomes
Measure
Description
Time Frame
Summary parameters of the dose volume histograms to the functional regions identified
One year
Cerebral blood flow and blood volume quantitated by relative measures normalized to regions of the brain not receiving any irradiation
90 days
Other Outcomes
Not provided
Eligibility Module
Eligibility 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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
120 Years
Standard Ages
AdultOlder Adult
Study Population
Base of skull and brain patients
Sampling Method
Non-Probability Sample
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Harry Quon, MD
Abramson Cancer Center at Penn Medicine
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Abramson Cancer Center of the University of Pennsylvania
Philadelphia
Pennsylvania
19104-4283
United States
References Module
Citations
Not provided
See Also Links
Label
URL
Clinical trial summary from the National Cancer Institute's PDQ® database