Head and Neck CancerFITTNCT00933114
Functional Imaging of Tumor and Normal Tissue
An observational study of Head and Neck Cancer, run by Duke University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- MRI and PET imaging
- Type of treatment
- Surgery or procedure
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to Radiation Oncology for radiotherapy of the NH cancer.
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- Clips in the central nervous system (ferromagnetic haemostatic)
- Automatic internal cardiac defibrillators
- Cochlear implants
- Shrapnel in vital locations
- Pregnant (positive pregnancy test) or lactating
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center, Department of Radiation Oncology
Durham, North Carolina, 27710
About this study
Official title: The Use of Functional Imaging to Quantify Tumor and Normal Tissue Physiology in Patients With Locally Advanced Head and Neck Cancer
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.
Read the 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.
- Conditions
- Head and Neck Cancer
- Being tested
- MRI and PET imaging
- Keywords
- DCE MRI, PET, Perfusion, Permeability, Cancer of the head and neck, Head, Neck neoplasms
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI and PET imagingProcedure or surgery
Dynamic Enhanced Magnetic Resonance Imaging (DEC-MRI) and positron emission tomography (PET) scan at baseline and after 1 week of radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| Functional Imaging | Functional imaging with MRI and PET Receives: Procedure: MRI and PET imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Permeability, perfusion, diffusion and glucose metabolism
Measured: 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
Measured: 1 year of completing radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2009 (estimated)
- Study startOct 2009
- Primary completionSep 2011
- Study completionSep 2011
Why it stopped: Funding ceased
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David S Yoo, MD, PhD, Principal investigator, Duke University Medical Center, Dept Radiation OncologyDavid M Brizel, MD, Principal investigator, Duke University Medical Center Dept Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00933114
- Sponsor's protocol ID
- Pro00014784
- Acronym
- FITT
- Status last verified
- Apr 2012
- First submitted
- 2 Jul 2009
- Last updated
- 11 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 7607933Kirkpatrick 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.
PubMed 15183486
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Functional Imaging to Quantify Tumor and Normal Tissue Physiology in Patients With Locally Advanced Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT00933114
- Acronym / sponsor ID
- FITT / Pro00014784
- Conditions
- Head and Neck Cancer
- Keywords
- DCE MRI, PET, Perfusion, Permeability, Cancer of the head and neck, Head, Neck neoplasms
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Funding ceased
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 7 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Functional Imaging | – | Procedure: MRI and PET imagingFunctional imaging with MRI and PET |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to Radiation Oncology for radiotherapy of the NH cancer.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- Diabetes other than diet controlled
- MRI Absolute Contraindications including:
- Pregnant (positive pregnancy test) or lactating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI and PET imagingDynamic Enhanced Magnetic Resonance Imaging (DEC-MRI) and positron emission tomography (PET) scan at baseline and after 1 week of radiation therapy | Procedure or surgery | Functional Imaging |
Primary outcome
Permeability, perfusion, diffusion and glucose metabolism
Time frame: At end of 1 week of radiation therapy
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: Funding ceased). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2012.
- Background: PubMed 7607933Brizel 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.
- Background: PubMed 15183486Kirkpatrick 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David S Yoo, MD, PhD principal investigator
Duke University Medical Center, Dept Radiation Oncology
David M Brizel, MD principal investigator
Duke University Medical Center Dept Radiation Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Funding ceased). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Permeability, perfusion, diffusion and glucose metabolism (time frame: At end of 1 week of radiation therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00933114, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2012.