Head and Neck CancerNCT00230295
Indirect Magnetic Resonance Lymphangiography of the Head and Neck Region Using Conventional Gadolinium-based Contrast
A study testing IMR LAG in people with Head and Neck Cancer and Head and Neck Cancers, run by Stanford University at 1 site in United States.
Trial summary
To determine the ability of magnetic resonance lymphangiography using conventional gadolinium injected directly into the tumor site and PET scan in detecting microscopic nodal metastasis in patients with newly diagnosed H\&N cancers Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Head and Neck Cancers
- What is being tested?
- IMR LAG
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2003to Nov 2007
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria:Patients with newly diagnosed squamous cell carcinomas of the H\&N with primary tumor sites that are accessible to direct contrast injections
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
To determine the ability of magnetic resonance lymphangiography using conventional gadolinium injected directly into the tumor site and PET scan in detecting microscopic nodal metastasis in patients with newly diagnosed H\&N cancers
- Conditions
- Head and Neck Cancer, Head and Neck Cancers
- Being tested
- IMR LAG
- 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.
IMR LAGProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
To determined the ability of magnetic resonance lymphangiography using conventional gadolinium injected directly into the tumor site and PET scan in detecting microscopic nodal metastasis in patients with newly diagnosed H&N cancers
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2005 (estimated)
- Study startFeb 2003
- Primary completionNov 2007
- Study completionNov 2007
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 Stanford 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
- Investigators
- Quynh-Thu Le, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00230295
- Sponsor's protocol ID
- ENT0010
- Other IDs
- ENT0010, NCT00230295
- Status last verified
- Jul 2010
- First submitted
- 28 Sep 2005
- Last updated
- 27 Jul 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indirect Magnetic Resonance Lymphangiography of the Head and Neck Region Using Conventional Gadolinium-based Contrast
- ClinicalTrials.gov ID
- NCT00230295
- Acronym / sponsor ID
- ENT0010
- Conditions
- Head and Neck Cancer, Head and Neck Cancers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
- Study start
- Feb 2003
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 30 Sep 2005 (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.
To determine the ability of magnetic resonance lymphangiography using conventional gadolinium injected directly into the tumor site and PET scan in detecting microscopic nodal metastasis in patients with newly diagnosed H\&N cancers
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- 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 |
|---|---|---|
| IMR LAG | Procedure or surgery | – |
Primary outcome
To determined the ability of magnetic resonance lymphangiography using conventional gadolinium injected directly into the tumor site and PET scan in detecting microscopic nodal metastasis in patients with newly diagnosed H&N cancers
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2010.
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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.
Quynh-Thu Le principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMR LAG in people with Head and Neck Cancer and Head and Neck Cancers, run by Stanford 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?
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: finished, as of the sponsor's last update on 27 Jul 2010. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determined the ability of magnetic resonance lymphangiography using conventional gadolinium injected directly into the tumor site and PET scan in detecting microscopic nodal metastasis in patients with newly diagnosed H&N cancers. 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 27 Jul 2010.