Head and Neck NeoplasmsNCT00159978
Validation of 18F-MISO-PET and 18F-FLT-PET
An observational study of Head and Neck Neoplasms, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Hypoxia and tumor cell proliferation are important mechanisms contributing to resistance to radiotherapy in human head and neck tumor cells. Currently, assessment of these two tumor characteristics is performed in biopsies using immunohistochemical staining and subsequent analysis. 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?
- 18F-FLT and 18F-MISO-PET
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 21 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2005to Dec 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Squamous cell carcinoma of the head and neck
Who may be able to join
- Stage II-IV squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx, planned for curative resection.
- Age >18 years.
- Written informed consent.
Who cannot join
- Pregnancy.
- Prior treatment for this tumor
- Women breast feeding
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
UMC St Radboud, Department of Radiotherapy
Nijmegen, Gelderland, 6500 HB
About this study
Official title: Validation of 18F-MISO-PET and 18F-FLT-PET by Immunohistochemical Assessment of Head and Neck Cancer Resection Specimen
Hypoxia and tumor cell proliferation are important mechanisms contributing to resistance to radiotherapy in human head and neck tumor cells. Currently, assessment of these two tumor characteristics is performed in biopsies using immunohistochemical staining and subsequent analysis. A promising non-invasive method of characterizing a tumor is the use of positron-emission tomography (PET). Specific tracers can be used to detect hypoxia and proliferative activity. 18F-misonidazole is a tracer for hypoxia and 18F-thymidine is a tracer for proliferation.
Patients suffering from head and neck cancer and who will undergo surgery will be included in this study.
Read more
One week before the surgery the patients will undergo a CT-scan and a PET-scan with either of the tracers. Shortly before the surgery they will be given immunohistochemically detectable marker substances enabling the characterization of the tumor samples gathered from the resection specimen. These markers are pimonidazole for detection of hypoxia and iododeoxyuridine for detection of tumor cell proliferation.
The data collected by PET-scan will be analysed and compared to the results acquired by immunohistochemistry.
- Conditions
- Head and Neck Neoplasms
- Being tested
- 18F-FLT and 18F-MISO-PET
- Keywords
- head and neck cancer, hypoxia, tumor cell proliferation, PET
- Medical subject headings
- Head and Neck Neoplasms, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FLT and 18F-MISO-PETProcedure or surgery
18F-FLT-PET-images will be acquired one hour after injection of 250 MBq FLT. 18F-MISO-PET: 400 MBq FMISO will be injected intravenously. Marker administration: The day before surgery (≤ 24h) pimonidazole (500 mg/m2) will be administered intravenously in 100 ml saline over 20 min. IdUrd (200 mg) will be administered as bolus injection 20 min before surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
To validate 18F-MISO-PET for detection of tumor hypoxia and 18F-FLT-PET for detection of tumor cell proliferation by immunohistochemical assessment of hypoxia and proliferation in head and neck cancer resection specimen.
Measured: 1 month
Secondary outcomes (1)
To assess if functional information obtained by 18F-MISO-PET and 18F-FLT-PET can improve the definition of target volume for radiotherapy treatment planning.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJul 2005
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: Problems with FMISO supply
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johannes HA Kaanders, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00159978
- Sponsor's protocol ID
- 100
- Status last verified
- May 2015
- First submitted
- 9 Sep 2005
- Last updated
- 7 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of 18F-MISO-PET and 18F-FLT-PET by Immunohistochemical Assessment of Head and Neck Cancer Resection Specimen
- ClinicalTrials.gov ID
- NCT00159978
- Acronym / sponsor ID
- 100
- Conditions
- Head and Neck Neoplasms
- Keywords
- head and neck cancer, hypoxia, tumor cell proliferation, PET
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Problems with FMISO supply
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 12 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.
Hypoxia and tumor cell proliferation are important mechanisms contributing to resistance to radiotherapy in human head and neck tumor cells. Currently, assessment of these two tumor characteristics is performed in biopsies using immunohistochemical staining and subsequent analysis. A promising non-invasive method of characterizing a tumor is the use of positron-emission tomography (PET). Specific tracers can be used to detect hypoxia and proliferative activity. 18F-misonidazole is a tracer for hypoxia and 18F-thymidine is a tracer for proliferation.
Patients suffering from head and neck cancer and who will undergo surgery will be included in this study.
One week before the surgery the patients will undergo a CT-scan and a PET-scan with either of the tracers. Shortly before the surgery they will be given immunohistochemically detectable marker substances enabling the characterization of the tumor samples gathered from the resection specimen. These markers are pimonidazole for detection of hypoxia and iododeoxyuridine for detection of tumor cell proliferation.
The data collected by PET-scan will be analysed and compared to the results acquired by immunohistochemistry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Squamous cell carcinoma of the head and neck
Key inclusion criteria (3 listed)
- Stage II-IV squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx, planned for curative resection.
- Age >18 years.
- Written informed consent.
Key exclusion criteria (3 listed)
- Pregnancy.
- Prior treatment for this tumor
- Women breast feeding
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 |
|---|---|---|
| 18F-FLT and 18F-MISO-PET18F-FLT-PET-images will be acquired one hour after injection of 250 MBq FLT. 18F-MISO-PET: 400 MBq FMISO will be injected intravenously. Marker administration: The day before surgery (≤ 24h) pimonidazole (500 mg/m2) will be administered intravenously in 100 ml saline over 20 min. IdUrd (200 mg) will be administered as bolus injection 20 min before surgery. | Procedure or surgery | – |
Primary outcome
To validate 18F-MISO-PET for detection of tumor hypoxia and 18F-FLT-PET for detection of tumor cell proliferation by immunohistochemical assessment of hypoxia and proliferation in head and neck cancer resection specimen.
Time frame: 1 month
1 secondary outcome
To assess if functional information obtained by 18F-MISO-PET and 18F-FLT-PET can improve the definition of target volume for radiotherapy treatment planning.
Time frame: 1 month
Results and safety
The study was stopped early (reason given: Problems with FMISO supply). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2015.
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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 HA Kaanders, PhD principal investigator
Radboud University Medical Center
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 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 3 inclusion and 3 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 7 May 2015. 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 was stopped early (reason given: Problems with FMISO supply). 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?
To validate 18F-MISO-PET for detection of tumor hypoxia and 18F-FLT-PET for detection of tumor cell proliferation by immunohistochemical assessment of hypoxia and proliferation in head and neck cancer resection specimen. (time frame: 1 month). 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 7 May 2015.