Head and Neck CancerPhase 1NCT00896350
MRI in Finding Hypoxia in Patients Undergoing Chemo and Radiation for Head and Neck Cancer
A Phase 1 study of Head and Neck Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
RATIONALE: Diagnostic procedures, such as functional MRI, may help measure oxygen levels in tumor cells and may help in planning cancer treatment. PURPOSE: This phase I trial is studying functional MRI to see how well it works in finding hypoxia in patients undergoing chemotherapy and radiation therapy for stage III… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Head and Neck Cancer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2009to Jul 2012
- Phase
- Phase 1
- 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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed squamous cell carcinoma of the head and neck
- Stage III or IV disease
- Measurable disease
- Scheduled to undergo standard treatment including radiation therapy and chemotherapy
- Participation on study # 092004-010 for tissue procurement
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Serum creatinine ≤ 1.5 OR creatinine clearance ≥ 40
- Body mass index ≤ 34 Kg/m^2
- Not claustrophobic
- No other contraindications to MRI (i.e., implanted pacemaker device)
- Not pregnant or nursing
- Negative pregnancy test
- No allergy to gadolinium
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
United States1 site
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, 75390
About this study
Official title: Predicting Treatment Response Based on Hypoxia in Head and Neck Cancers Using Non-Invasive Oxygen Sensitive MRI
RATIONALE: Diagnostic procedures, such as functional MRI, may help measure oxygen levels in tumor cells and may help in planning cancer treatment.
PURPOSE: This phase I trial is studying functional MRI to see how well it works in finding hypoxia in patients undergoing chemotherapy and radiation therapy for stage III or stage IV head and neck cancer.
Read the detailed description
OBJECTIVES:
- Determine the undertaken oxygen sensitive MRI for the detection of hypoxia in patients with Stage III-IV head and neck cancer.
- Correlate MRI parameters with histology, gene expression, and plasma osteopontin.
- Correlate tumor hypoxia measurements with patient prognosis and treatment response.
OUTLINE:
- Pre-therapy MRI: Patients undergo blood oxygen level dependant (BOLD) contrast MRI on room air breathing over 2 minutes and with oxygen gas over 15 minutes. Patients also undergo MR-spectroscopy over 15 minutes to measure choline and lactate markers, and dynamic contrast MRI with gadolinium contrast over 8 minutes.
- Chemoradiotherapy: Patients receive platinum based chemotherapy every two weeks. Patients also undergo radiation therapy for 6 weeks.
- Post-radiation MRI: Patients undergo MRI as before chemoradiotherapy. Blood and tumor samples are collected at baseline for biomarker analysis associated with tumor progression or response.
After completion of study, patients are followed every 3 months for up to 1 year.
- Conditions
- Head and Neck Cancer
- Being tested
- Standard Care Chemoradiation
- 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.
Standard Care ChemoradiationDrug
External beam radiation to the neck and tumor site of head and neck. Concurrent platinum based chemotherapy. External beam "boost" at discretion of treating physician.
| Study group | Role | What they receive |
|---|---|---|
| BOLD MRI | Experimental | Determine the amount of oxygen supply to tumors. Receives: Drug: Standard Care Chemoradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI signal sensitivity to oxygen
MRI signal sensitivity to oxygen breathing and delayed contrast-enhancement (DCE)
Measured: 12 weeks
Tumor shrinkage and blood oxygen association
Association between tumor shrinkage and blood oxygen level dependent
Measured: 12 weeks
Secondary outcomes (1)
Correlate tumor hypoxia with patient prognosis and treatment response
Association between tumor hypoxia, patient prognosis, and treatment response.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2009 (estimated)
- Study start8 Jul 2009
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Baran Sumer, MD, Principal investigator, Simmons Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00896350
- Sponsor's protocol ID
- SCCC-02308
- Other IDs
- CDR0000637640, NCI-2011-02811
- Status last verified
- Feb 2019
- First submitted
- 8 May 2009
- Last updated
- 18 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Treatment Response Based on Hypoxia in Head and Neck Cancers Using Non-Invasive Oxygen Sensitive MRI
- ClinicalTrials.gov ID
- NCT00896350
- Acronym / sponsor ID
- SCCC-02308
- Conditions
- Head and Neck Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 8 Jul 2009 (actual)
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 11 May 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.
RATIONALE: Diagnostic procedures, such as functional MRI, may help measure oxygen levels in tumor cells and may help in planning cancer treatment.
PURPOSE: This phase I trial is studying functional MRI to see how well it works in finding hypoxia in patients undergoing chemotherapy and radiation therapy for stage III or stage IV head and neck cancer.
Detailed description
OBJECTIVES:
- Determine the undertaken oxygen sensitive MRI for the detection of hypoxia in patients with Stage III-IV head and neck cancer.
- Correlate MRI parameters with histology, gene expression, and plasma osteopontin.
- Correlate tumor hypoxia measurements with patient prognosis and treatment response.
OUTLINE:
- Pre-therapy MRI: Patients undergo blood oxygen level dependant (BOLD) contrast MRI on room air breathing over 2 minutes and with oxygen gas over 15 minutes. Patients also undergo MR-spectroscopy over 15 minutes to measure choline and lactate markers, and dynamic contrast MRI with gadolinium contrast over 8 minutes.
- Chemoradiotherapy: Patients receive platinum based chemotherapy every two weeks. Patients also undergo radiation therapy for 6 weeks.
- Post-radiation MRI: Patients undergo MRI as before chemoradiotherapy. Blood and tumor samples are collected at baseline for biomarker analysis associated with tumor progression or response.
After completion of study, patients are followed every 3 months for up to 1 year.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BOLD MRI | Experimental | Drug: Standard Care ChemoradiationDetermine the amount of oxygen supply to tumors. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Standard Care ChemoradiationExternal beam radiation to the neck and tumor site of head and neck. Concurrent platinum based chemotherapy. External beam "boost" at discretion of treating physician. | Drug | BOLD MRI |
Primary outcome
MRI signal sensitivity to oxygen
Time frame: 12 weeks
MRI signal sensitivity to oxygen breathing and delayed contrast-enhancement (DCE)
Tumor shrinkage and blood oxygen association
Time frame: 12 weeks
Association between tumor shrinkage and blood oxygen level dependent
1 secondary outcome
Correlate tumor hypoxia with patient prognosis and treatment response
Time frame: 12 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
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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.
Baran Sumer, MD principal investigator
Simmons Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Head and Neck Cancer, run by University of Texas Southwestern Medical Center 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?
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 18 Feb 2019. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. 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?
MRI signal sensitivity to oxygen (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2019.