NCT00933114

Brief Summary

Dynamic contrast-enhanced (DCE) - magnetic resonance imaging (MRI), diffusion-weighted (DW)-MRI, and fludeoxyglucose - positron emission tomography - computed tomography (FDG-PET-CT) are three modalities that generate non-invasive, functional images of tumors and normal tissues based on physiologic properties including perfusion, vascular permeability and glucose metabolism. Demonstrating that these parameters are associated with clinical outcome, either efficacy or toxicity, could enhance the ability to select patients for different treatment strategies and improve the therapeutic ratio.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

July 2, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 7, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

April 11, 2012

Status Verified

April 1, 2012

Enrollment Period

1.9 years

First QC Date

July 2, 2009

Last Update Submit

April 10, 2012

Conditions

Head and Neck Cancer

Keywords

DCE MRIPETPerfusionPermeabilityCancer of the head and neckHead, Neck neoplasms

Outcome Measures

Primary Outcomes (1)

  • Permeability, perfusion, diffusion and glucose metabolism

    At end of 1 week of radiation therapy

Secondary Outcomes (1)

  • Relationships between baseline and treatment induced changes in vascular permeability, perfusion, interstitial space, glucose metabolism, and saliva production to identify prognostic and predictive parameter(s) for treatment

    1 year of completing radiation therapy

Study Arms (1)

Functional Imaging

Functional imaging with MRI and PET

Procedure: MRI and PET imaging

Interventions

MRI and PET imagingPROCEDURE

Dynamic Enhanced Magnetic Resonance Imaging (DEC-MRI) and positron emission tomography (PET) scan at baseline and after 1 week of radiation therapy

Functional Imaging

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting to Radiation Oncology for radiotherapy of the NH cancer.

You may qualify if:

  • Histologically documented squamous cell carcinoma of the head and neck (AJCC stages II-IV, M0)
  • Eligible anatomic sites: Oral cavity, oropharynx, hypopharynx, supraglottic and glottic larynx, or nasopharynx
  • Curative intent concurrent chemoradiation
  • Age \> 18 years
  • Karnofsky Performance Status \> 60
  • Able to undergo MRI with contrast (gadolinium) and/or FDG PET scan

You may not qualify if:

  • Diabetes other than diet controlled
  • MRI Absolute Contraindications including:
  • Glomerular filtration rate \< 60 ml/min
  • Weight \< 350 lb or current device limitations
  • Metallic foreign bodies in the eye
  • Cardiac pacemakers
  • Clips in the central nervous system (ferromagnetic haemostatic)
  • Automatic internal cardiac defibrillators
  • Cochlear implants
  • Shrapnel in vital locations
  • Pregnant (positive pregnancy test) or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center, Department of Radiation Oncology

Durham, North Carolina, 27710, United States

Location

Related Publications (2)

  • Brizel DM, Rosner GL, Prosnitz LR, Dewhirst MW. Patterns and variability of tumor oxygenation in human soft tissue sarcomas, cervical carcinomas, and lymph node metastases. Int J Radiat Oncol Biol Phys. 1995 Jul 15;32(4):1121-5. doi: 10.1016/0360-3016(95)00106-9.

    PMID: 7607933BACKGROUND

  • Kirkpatrick JP, Cardenas-Navia LI, Dewhirst MW. Predicting the effect of temporal variations in PO2 on tumor radiosensitivity. Int J Radiat Oncol Biol Phys. 2004 Jul 1;59(3):822-33. doi: 10.1016/j.ijrobp.2004.02.015.

    PMID: 15183486BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • David S Yoo, MD, PhD

    Duke University Medical Center, Dept Radiation Oncology

    PRINCIPAL INVESTIGATOR

  • David M Brizel, MD

    Duke University Medical Center Dept Radiation Oncology

    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

July 2, 2009

First Posted

July 7, 2009

Study Start

October 1, 2009

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

April 11, 2012

Record last verified: 2012-04

Locations

US(1)