NCT00984074

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 24, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

April 24, 2019

Status Verified

April 1, 2019

Enrollment Period

3.2 years

First QC Date

September 23, 2009

Last Update Submit

April 22, 2019

Conditions

Head and Neck Cancer

Keywords

stage III salivary gland cancerrecurrent squamous cell carcinoma of the hypopharynxstage I squamous cell carcinoma of the hypopharynxstage II squamous cell carcinoma of the hypopharynxstage III squamous cell carcinoma of the hypopharynxrecurrent squamous cell carcinoma of the larynxrecurrent verrucous carcinoma of the larynxstage I squamous cell carcinoma of the larynxstage I verrucous carcinoma of the larynxstage II squamous cell carcinoma of the larynxstage II verrucous carcinoma of the larynxstage III squamous cell carcinoma of the larynxstage III verrucous carcinoma of the larynxrecurrent adenoid cystic carcinoma of the oral cavityrecurrent mucoepidermoid carcinoma of the oral cavityrecurrent verrucous carcinoma of the oral cavitystage I adenoid cystic carcinoma of the oral cavitystage I mucoepidermoid carcinoma of the oral cavitystage I verrucous carcinoma of the oral cavitystage II adenoid cystic carcinoma of the oral cavitystage II mucoepidermoid carcinoma of the oral cavitystage II verrucous carcinoma of the oral cavitystage III adenoid cystic carcinoma of the oral cavitystage III mucoepidermoid carcinoma of the oral cavitystage III verrucous carcinoma of the oral cavitystage I squamous cell carcinoma of the lip and oral cavitystage II squamous cell carcinoma of the lip and oral cavitystage III squamous cell carcinoma of the lip and oral cavityrecurrent basal cell carcinoma of the liprecurrent squamous cell carcinoma of the lip and oral cavitystage I basal cell carcinoma of the lipstage II basal cell carcinoma of the lipstage III basal cell carcinoma of the liprecurrent metastatic squamous neck cancer with occult primaryuntreated metastatic squamous neck cancer with occult primaryrecurrent lymphoepithelioma of the nasopharynxrecurrent squamous cell carcinoma of the nasopharynxstage I lymphoepithelioma of the nasopharynxstage I squamous cell carcinoma of the nasopharynxstage II lymphoepithelioma of the nasopharynxstage II squamous cell carcinoma of the nasopharynxstage III lymphoepithelioma of the nasopharynxstage III squamous cell carcinoma of the nasopharynxrecurrent lymphoepithelioma of the oropharynxrecurrent squamous cell carcinoma of the oropharynxstage I lymphoepithelioma of the oropharynxstage I squamous cell carcinoma of the oropharynxstage II lymphoepithelioma of the oropharynxstage II squamous cell carcinoma of the oropharynxstage III lymphoepithelioma of the oropharynxstage III squamous cell carcinoma of the oropharynxrecurrent esthesioneuroblastoma of the paranasal sinus and nasal cavityrecurrent inverted papilloma of the paranasal sinus and nasal cavityrecurrent midline lethal granuloma of the paranasal sinus and nasal cavityrecurrent squamous cell carcinoma of the paranasal sinus and nasal cavitystage I esthesioneuroblastoma of the paranasal sinus and nasal cavitystage I inverted papilloma of the paranasal sinus and nasal cavitystage I midline lethal granuloma of the paranasal sinus and nasal cavitystage I squamous cell carcinoma of the paranasal sinus and nasal cavitystage II esthesioneuroblastoma of the paranasal sinus and nasal cavitystage II inverted papilloma of the paranasal sinus and nasal cavitystage II midline lethal granuloma of the paranasal sinus and nasal cavitystage II squamous cell carcinoma of the paranasal sinus and nasal cavitystage III esthesioneuroblastoma of the paranasal sinus and nasal cavitystage III inverted papilloma of the paranasal sinus and nasal cavitystage III midline lethal granuloma of the paranasal sinus and nasal cavitystage III squamous cell carcinoma of the paranasal sinus and nasal cavityhigh-grade salivary gland mucoepidermoid carcinomalow-grade salivary gland mucoepidermoid carcinomarecurrent salivary gland cancersalivary gland acinic cell tumorsalivary gland adenocarcinomasalivary gland adenoid cystic carcinomasalivary gland anaplastic carcinomasalivary gland malignant mixed cell type tumorsalivary gland poorly differentiated carcinomasalivary gland squamous cell carcinomastage I salivary gland cancerstage II salivary gland cancertongue cancer

Outcome Measures

Primary Outcomes (1)

  • Feasability, as assessed by the proportion of study patients with functional regions identified within the brain as receiving exit irradiation

    90 days

Secondary Outcomes (2)

  • 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

Interventions

blood-oxygen-level-dependent functional magnetic resonance imagingPROCEDURE
diffusion tensor imagingPROCEDURE
dynamic contrast-enhanced magnetic resonance imagingPROCEDURE
functional magnetic resonance imagingPROCEDURE
intensity-modulated radiation therapyRADIATION
radiation therapy treatment planning/simulationRADIATION

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Base of skull and brain patients

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Related Links

MeSH Terms

Conditions

Head and Neck NeoplasmsSalivary Gland NeoplasmsSquamous Cell Carcinoma of Head and NeckEsthesioneuroblastoma, OlfactoryTongue Neoplasms

Interventions

Diffusion Tensor ImagingRadiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsMouth NeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland DiseasesCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeuroblastomaNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueOlfactory Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesTongue Diseases

Intervention Hierarchy (Ancestors)

NeuroimagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiffusion Magnetic Resonance ImagingMagnetic Resonance ImagingTomographyDiagnostic Techniques, NeurologicalInvestigative TechniquesRadiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

Study Officials

  • Harry Quon, MD

    Abramson Cancer Center at Penn Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2009

First Posted

September 24, 2009

Study Start

October 1, 2008

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

April 24, 2019

Record last verified: 2019-04

Locations

US(1)