Head and Neck CancerNCT00606294
Using Fluorine-18-Labeled Fluoro-Misonidazole Positron Emission Tomography To Detect Hypoxia in Head and Neck Cancer Patients
A study testing fluorine-18-labeled fluoro-misonidazole (18F-FMISO), 18F-FMISO PET scan and MRI in people with Head and Neck Cancer, run by Memorial Sloan Kettering Cancer Center at 5 sites in United States.
Trial summary
The main purpose of this study is to evaluate low oxygen areas called hypoxia within tumors. These low oxygen areas are thought to be the reason why tumors are more resistant to chemotherapy and radiation treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- fluorine-18-labeled fluoro-misonidazole (18F-FMISO), 18F-FMISO PET scan and MRI
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 5 sitesUnited States
- Study dates
- Jun 2004to 9 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Histologically confirmed diagnosis of head and neck carcinoma (excluding nasopharynx, paranasal sinus, salivary, and thyroid malignancies)Any unknown primary squamous cell carcinoma of head and neck with gross nodes is allowed (2002 AJCC)
- 18 years of age or older
- Must not have received prior radiation therapy or chemotherapy for this diagnosis. Patients who have had their primary site tumor removed by surgery but still present with grossly enlarged lymph nodes are eligible for this study.
- Karnofsky performance status ≥ 70.
Who cannot join
- all nasopharyngeal, paranasal sinus, salivary cancer, and thyroid malignancies
- prior chemotherapy or radiotherapy within the last three years
- patients that underwent previous surgical resection for the same disease (except for biopsy or surgery removing primary site tumor but still present with grossly enlarged lymph nodes)
- any prior radiotherapy to the head and neck region
- pregnant (confirmed by serum b-HCG in women of reproductive age) or breast feeding
- Subject Exclusion Criteria for Optional Contrast MRIs
- Subjects with a known contraindication to the standard MRI contrast agent (Gadavist, a gadolinium-based contrast agent) and/or a recent estimated glomerular filtration rate (eGFR) of 30 or less will be excluded from all DCE-MRIs, and will instead receive non-contrast MRIs at the DCE-MRI time points.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Memorial Sloan Kettering Cancer Center at Basking Ridge
Basking Ridge, New Jersey
Memorial Sloan Kettering Cancer Center at Commack
Commack, New York, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Cancer Center at Mercy Medical Center
Rockville Centre, New York, 11570
About this study
Official title: A Study Using Fluorine-18-Labeled Fluoro-Misonidazole Positron Emission Tomography To Detect Hypoxia in Head and Neck Cancer Patients
The main purpose of this study is to evaluate low oxygen areas called hypoxia within tumors. These low oxygen areas are thought to be the reason why tumors are more resistant to chemotherapy and radiation treatment.
An imaging technique using a hypoxia tracer called fluoromisonidazole (FMISO) can detect low oxygen areas within a tumor. This imaging technique, called a PET scan, uses positively charged particles to detect slight changes in the body's biochemistry and metabolism. FMISO PET scans have been performed in patients with head and neck cancer and have shown the ability to detect low oxygen areas within tumors.
- Conditions
- Head and Neck Cancer
- Being tested
- fluorine-18-labeled fluoro-misonidazole (18F-FMISO), 18F-FMISO PET scan, MRI, FDG PET/CT scan
- Keywords
- Head, Neck, 04-070
- 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.
fluorine-18-labeled fluoro-misonidazole (18F-FMISO)Radiation
18F-FMISO PET scanDevice
MRIDevice
FDG PET/CT scanDevice
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (closed to accrual) | Experimental | Cohort 1 (closed to accrual) Cohort 1 (closed to accrual) There will be no change or intervention in a patient's treatment regime using chemoradiation where both the primary and the neck nodes receive 70Gy. This is currently one accepted standard of care. In a subcohort of patients in Cohort 1 with tumors that are positive for HPV who exhibited no evidence of hypoxia on their baseline 18F-FMISO PET/ CT scan or whose tumors have early resolution of hypoxia on their repeat early response 18F-FMISO PET/CT scan will undergo an alternative treatment where the primary tumor site receives 70Gy while the neck nodes receive 60Gy followed by a planned FDG PET/CT scan and observation. Receives: Radiation: fluorine-18-labeled fluoro-misonidazole (18F-FMISO); Device: 18F-FMISO PET scan; Device: MRI; Device: FDG PET/CT scan |
| Cohort 2 (closed to accrual) | Experimental | Experimental: Cohort 2 (closed to accrual) Cohort 2 HPV+ tumors that demonstrate no evidence of hypoxia on an 18F-FMISO PET scan will receive 30Gy to the surgical bed and neck lymph nodes concurrent with standard chemotherapy followed by a 3-4 month post-treatment neck dissection. In patients who exhibit a complete response with this method of treatment, no further treatment is necessary. For patients within this select group who still have pathologic nodal disease, further standard chemoradiation will be given. All other patients in this cohort (i.e. those who are not in the select HPV+ tumor group outlined above) will receive standard of care treatment following their surgery. Receives: Radiation: fluorine-18-labeled fluoro-misonidazole (18F-FMISO); Device: 18F-FMISO PET scan; Device: MRI; Device: FDG PET/CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Report Positive Versus Negative Hypoxia Among Head and Neck Cancers Using 18F-FMISO Dynamic PET
For Cohort 1
Measured: 4 months
To Determine the Pathologic Complete Response of Low Risk HPV+ Oropharyngeal Cancer Patients Without Hypoxia on 18F-FMISO PET Who Received 30Gy
For Cohort 2 - Feasibility will be determined by the pathologic response rate at time of neck dissection
Measured: 4 months
Improve the Accuracy of Hypoxia Imaging for Head and Neck Cancers Through Pixel by Pixel Kinetic Analysis of 18F-FMISO Tracer of Dynamic PET Images
Cohort 2
Measured: At baseline
Secondary outcomes (1)
To Detect on Repeat 18F-FMISO PET/CT Scans Whether There is a Reduction of the FMISO-avid or GTVh 5 to 10 Days Into Treatment With Standard Chemoradiotherapy for a Series of Locally Advanced Head and Neck Cancers.
For Cohort 1
Measured: 2 weeks from time of scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2008 (estimated)
- Study startJun 2004
- Primary completionAug 2019
- Study completion9 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nancy Lee, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00606294
- Sponsor's protocol ID
- 04-070
- Status last verified
- Jun 2023
- First submitted
- 10 Jan 2008
- Last updated
- 28 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Using Fluorine-18-Labeled Fluoro-Misonidazole Positron Emission Tomography To Detect Hypoxia in Head and Neck Cancer Patients
- ClinicalTrials.gov ID
- NCT00606294
- Acronym / sponsor ID
- 04-070
- Conditions
- Head and Neck Cancer
- Keywords
- Head, Neck, 04-070
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Jun 2004 (actual)
- Primary completion
- Aug 2019 (actual)
- Study completion
- 9 Jun 2023 (actual)
- First posted
- 1 Feb 2008 (estimated)
- Results
- Posted 10 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to evaluate low oxygen areas called hypoxia within tumors. These low oxygen areas are thought to be the reason why tumors are more resistant to chemotherapy and radiation treatment.
An imaging technique using a hypoxia tracer called fluoromisonidazole (FMISO) can detect low oxygen areas within a tumor. This imaging technique, called a PET scan, uses positively charged particles to detect slight changes in the body's biochemistry and metabolism. FMISO PET scans have been performed in patients with head and neck cancer and have shown the ability to detect low oxygen areas within tumors.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (closed to accrual) | Experimental | Radiation: fluorine-18-labeled fluoro-misonidazole (18F-FMISO), Device: 18F-FMISO PET scan, Device: MRI, Device: FDG PET/CT scanCohort 1 (closed to accrual) Cohort 1 (closed to accrual) There will be no change or intervention in a patient's treatment regime using chemoradiation where both the primary and the neck nodes receive 70Gy. This is currently one accepted standard of care. In a subcohort of patients in Cohort 1 with tumors that are positive for HPV who exhibited no evidence of hypoxia on their baseline 18F-FMISO PET/ CT scan or whose tumors have early resolution of hypoxia on their repeat early response 18F-FMISO PET/CT scan will undergo an alternative treatment where the primary tumor site receives 70Gy while the neck nodes receive 60Gy followed by a planned FDG PET/CT scan and observation. |
| Cohort 2 (closed to accrual) | Experimental | Radiation: fluorine-18-labeled fluoro-misonidazole (18F-FMISO), Device: 18F-FMISO PET scan, Device: MRI, Device: FDG PET/CT scanExperimental: Cohort 2 (closed to accrual) Cohort 2 HPV+ tumors that demonstrate no evidence of hypoxia on an 18F-FMISO PET scan will receive 30Gy to the surgical bed and neck lymph nodes concurrent with standard chemotherapy followed by a 3-4 month post-treatment neck dissection. In patients who exhibit a complete response with this method of treatment, no further treatment is necessary. For patients within this select group who still have pathologic nodal disease, further standard chemoradiation will be given. All other patients in this cohort (i.e. those who are not in the select HPV+ tumor group outlined above) will receive standard of care treatment following their surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically confirmed diagnosis of head and neck carcinoma (excluding nasopharynx, paranasal sinus, salivary, and thyroid malignancies)Any unknown primary squamous cell carcinoma of head and neck with gross nodes is allowed (2002 AJCC)
- 18 years of age or older
- Must not have received prior radiation therapy or chemotherapy for this diagnosis. Patients who have had their primary site tumor removed by surgery but still present with grossly enlarged lymph nodes are eligible for this study.
- Karnofsky performance status ≥ 70.
Key exclusion criteria (7 listed)
- all nasopharyngeal, paranasal sinus, salivary cancer, and thyroid malignancies
- prior chemotherapy or radiotherapy within the last three years
- patients that underwent previous surgical resection for the same disease (except for biopsy or surgery removing primary site tumor but still present with grossly enlarged lymph nodes)
- any prior radiotherapy to the head and neck region
- pregnant (confirmed by serum b-HCG in women of reproductive age) or 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 |
|---|---|---|
| fluorine-18-labeled fluoro-misonidazole (18F-FMISO) | Radiation | Cohort 1 (closed to accrual), Cohort 2 (closed to accrual) |
| 18F-FMISO PET scan | Device | Cohort 1 (closed to accrual), Cohort 2 (closed to accrual) |
| MRI | Device | Cohort 1 (closed to accrual), Cohort 2 (closed to accrual) |
| FDG PET/CT scan | Device | Cohort 1 (closed to accrual), Cohort 2 (closed to accrual) |
Primary outcome
To Report Positive Versus Negative Hypoxia Among Head and Neck Cancers Using 18F-FMISO Dynamic PET
Time frame: 4 months
For Cohort 1
To Determine the Pathologic Complete Response of Low Risk HPV+ Oropharyngeal Cancer Patients Without Hypoxia on 18F-FMISO PET Who Received 30Gy
Time frame: 4 months
For Cohort 2 - Feasibility will be determined by the pathologic response rate at time of neck dissection
Improve the Accuracy of Hypoxia Imaging for Head and Neck Cancers Through Pixel by Pixel Kinetic Analysis of 18F-FMISO Tracer of Dynamic PET Images
Time frame: At baseline
Cohort 2
1 secondary outcome
To Detect on Repeat 18F-FMISO PET/CT Scans Whether There is a Reduction of the FMISO-avid or GTVh 5 to 10 Days Into Treatment With Standard Chemoradiotherapy for a Series of Locally Advanced Head and Neck Cancers.
Time frame: 2 weeks from time of scan
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Nancy Lee, MD principal investigator
Memorial Sloan Kettering Cancer Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fluorine-18-labeled fluoro-misonidazole (18F-FMISO), 18F-FMISO PET scan and MRI in people with Head and Neck Cancer, run by Memorial Sloan Kettering Cancer Center at 5 sites 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 4 inclusion and 7 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 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Yes. Results are posted in the registry (first posted 10 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Report Positive Versus Negative Hypoxia Among Head and Neck Cancers Using 18F-FMISO Dynamic PET (time frame: 4 months). The study lists 3 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 28 Jun 2023.