Head and Neck NeoplasmsNCT00184860
The Role of CT-PET-MRI Image Fusion in Determining Radiation Treatment Volumes of Head-and-Neck Cancer Patients
A study testing PET-scan, MRI-scan in people with Head and Neck Neoplasms, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Technical developments in radiation oncology are making it possible to deliver a prescribed radiation dose to radiation target volume with increasing accuracy. Therefore it is becoming even more relevant to accurately define the radiation target volumes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- PET-scan, MRI-scan
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2003to not given
- 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
Who may be able to join
- Patients eligible for definitive radiotherapy with a Head and Neck Neoplasm (squamous cell carcinoma) in one of the following anatomical sites:
- oral cavity
- oropharynx
- hypopharynx
- larynx
Who cannot join
- age < 18 years
- pregnancy
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, 6500HB
About this study
Official title: The Value of CT-PET-MRI Image Fusion in Determining Radiation Treatment Volumes in Patients With a Squamous Cell Carcinoma of the Head-and-Neck Region, Who Are to be Treated With Definitive Radiotherapy
Technical developments in radiation oncology are making it possible to deliver a prescribed radiation dose to radiation target volume with increasing accuracy.
Therefore it is becoming even more relevant to accurately define the radiation target volumes.
The current standard in defining radiation target volumes in patients with head-and-neck cancer is to combine physical examination data with a CT-scan in the treatment position.
The goal of this investigation is to analyse the rol of CT-PET-MRI image fusion in defining radiation target volumes.
- Conditions
- Head and Neck Neoplasms
- Being tested
- PET-scan, MRI-scan
- 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.
PET-scan, MRI-scanProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by Radboud University 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Johannes H Kaanders, MD. PhD, Study director, Radiation oncologist, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00184860
- Sponsor's protocol ID
- 2004/153
- Status last verified
- Apr 2007
- First submitted
- 12 Sep 2005
- Last updated
- 27 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of CT-PET-MRI Image Fusion in Determining Radiation Treatment Volumes in Patients With a Squamous Cell Carcinoma of the Head-and-Neck Region, Who Are to be Treated With Definitive Radiotherapy
- ClinicalTrials.gov ID
- NCT00184860
- Acronym / sponsor ID
- 2004/153
- Conditions
- Head and Neck Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jun 2003
- First posted
- 16 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.
Technical developments in radiation oncology are making it possible to deliver a prescribed radiation dose to radiation target volume with increasing accuracy.
Therefore it is becoming even more relevant to accurately define the radiation target volumes.
The current standard in defining radiation target volumes in patients with head-and-neck cancer is to combine physical examination data with a CT-scan in the treatment position.
The goal of this investigation is to analyse the rol of CT-PET-MRI image fusion in defining radiation target volumes.
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
Key inclusion criteria (5 listed)
- Patients eligible for definitive radiotherapy with a Head and Neck Neoplasm (squamous cell carcinoma) in one of the following anatomical sites:
- oral cavity
- oropharynx
- hypopharynx
- larynx
Key exclusion criteria (2 listed)
- age < 18 years
- pregnancy
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 |
|---|---|---|
| PET-scan, MRI-scan | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 Apr 2007.
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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.
Johannes H Kaanders, MD. PhD study director
Radiation oncologist, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET-scan, MRI-scan in people with Head and Neck Neoplasms, run by Radboud University Medical Center at 1 site in Netherlands.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 27 Apr 2007. 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 Netherlands. 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.
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 Apr 2007.