Functional Imaging of Tumor and Normal Tissue (FITT)
This study has been terminated.
(Funding ceased)
Sponsor:
Duke University
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00933114
First received: July 2, 2009
Last updated: April 10, 2012
Last verified: April 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | July 2, 2009 | ||||||||
| Last Updated Date | April 10, 2012 | ||||||||
| Start Date ICMJE | October 2009 | ||||||||
| Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Permeability, perfusion, diffusion and glucose metabolism [ Time Frame: At end of 1 week of radiation therapy ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Temporal variability of permeability, perfusion, diffusion and glucose metabolism as measured in both tumor and the parotid gland [ Time Frame: At end of 1 week of radiation therapy ] [ Designated as safety issue: No ] | ||||||||
| Change History | Complete list of historical versions of study NCT00933114 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 [ Time Frame: 1 year of completing radiation therapy ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Functional Imaging of Tumor and Normal Tissue | ||||||||
| Official Title ICMJE | The Use of Functional Imaging to Quantify Tumor and Normal Tissue Physiology in Patients With Locally Advanced Head and Neck Cancer | ||||||||
| 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. |
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| Detailed Description | Patients will undergo functional imaging studies, DCE-MRI pre-treatment (twice) and after 1 week of Radiation Therapy (RT) and PET scans - pre-treatment and after 1 week of RT. Parotid gland saliva production will also be measured at baseline and at 3, 6, and 12 months of follow-up. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Patients presenting to Radiation Oncology for radiotherapy of the NH cancer. |
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| Condition ICMJE | Head and Neck Cancer | ||||||||
| Intervention ICMJE | Procedure: MRI and PET imaging
Dynamic Enhanced Magnetic Resonance Imaging (DEC-MRI) and positron emission tomography (PET) scan at baseline and after 1 week of radiation therapy |
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| Study Group/Cohort (s) | Functional Imaging
Functional imaging with MRI and PET
Intervention: Procedure: MRI and PET imaging |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Terminated | ||||||||
| Enrollment ICMJE | 21 | ||||||||
| Completion Date | September 2011 | ||||||||
| Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00933114 | ||||||||
| Other Study ID Numbers ICMJE | Pro00014784 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Duke University | ||||||||
| Study Sponsor ICMJE | Duke University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Duke University | ||||||||
| Verification Date | April 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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