Squamous Cell CarcinomaNCT00038038
Assessment of Head and Neck Tumor Hypoxia Using 18F-Fluoromisonidazole
A study testing 18F-fluoromisonidazole and PET scan in people with Squamous Cell Carcinoma and Head and Neck Neoplasms, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The purpose of this clinical research study is to answer the following questions using 18F-fluoromisonidazole as an imaging agent: 1. Do cells exist in human tumors that are at very low oxygen levels (hypoxic cells)? 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma, Head and Neck Neoplasms, Metastases, Neoplasm
- What is being tested?
- 18F-fluoromisonidazole and PET scan
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1994to Jun 2003
- 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
- Histologically proven squamous cell carcinoma of head and neck wth metastatic neck nodes greater than or equal to 2cm
- Karnofsky performance status greater or equal to 60%
Who cannot join
- No prior irradiation or surgery to head/neck area
- No prior chemotherapy within 1 month of participation and have recovered from associated related effects
- Not pregnant
- Any intercurrent medical or physiologic disorder which would prevent informed consent
- Underlying medical problems which would compromise technical ability to deliver a "standard course" of radiation therapy
- Patients with PT or PTT over 1.5 times normal
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
About this study
The purpose of this clinical research study is to answer the following questions using 18F-fluoromisonidazole as an imaging agent:
- Do cells exist in human tumors that are at very low oxygen levels (hypoxic cells)?
- If hypoxic cells exist in human tumors, do they effect the ability of radiotherapy to control human tumors?
- Can Positron Emission Tomography (PET scanning) detect hypoxic cells in human tumors?
Read the detailed description
Hypoxic (low oxygen) cells have long been known to exist in animal tumors. It is also known that hypoxic cells are more difficult to eliminate with radiotherapy than tumor cells at normal levels of oxygen (normoxic cells). However, the extent to which hypoxic cells limit the curability of human tumors is uncertain. To determine if hypoxic cells exist in human tumors and how hypoxic cells might influence the efficacy of radiotherapy, this study involves direct measurements of oxygen levels in human tumors compared to the tumor uptake of the experimental drug, 18F-fluoromisonidazole (18F-FMISO), visualized with PET scanning. 18F-fluoromisonidazole has been used with PET imaging to tell the difference between growing tumors which have high and low oxygen content.
Before beginning radiotherapy, a PET scan (series of pictures, 20 min. scan) will be performed at 2 hours after an intravenous injection of a small amount of radioactive traces drug, 18F-fluoromisonidazole (18F-FMISO) to observe the active hypoxia tumors areas. Upon completion of the 18F-FMISO PET scan, direct oxygen measurements will be obtained by placing a small needle into the tumor under computer tomographic (CT) guidance. The PET scan and needle measurements will be repeated every 4 weeks into the course of radiotherapy and again after the completion of radiotherapy. The measurement obtained by 18F-FMISO PET scanning (non-invasive technique) and by direct needle measurements (invasive technique) will be correlated with the eventual treatment outcome for future use.
- Being tested
- 18F-fluoromisonidazole, PET scan
- Keywords
- Squamous cell carcinoma of head and neck
- Medical subject headings
- Carcinoma, Squamous Cell, Head and Neck Neoplasms, Neoplasm Metastasis, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-fluoromisonidazoleDrug
Also called 18F-FMISO
Small amount of radioactive traces drug given by intravenous injection prior to PET Scan
PET scanProcedure or surgery
Series of pictures using 20 minute scan performed 2 hours after an 18F-fluoromisonidazole injection
| Study group | Role | What they receive |
|---|---|---|
| PET + 18F-fluoromisonidazole | Experimental | Not described Receives: Drug: 18F-fluoromisonidazole; Procedure: PET scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Direct Oxygen Measurements
Measured: PET scan and needle measurements will be repeated every 4 weeks into the course of radiotherapy and again after the completion of radiotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2002 (estimated)
- Study startJan 1994
- Primary completionJun 2003
- Study completionJun 2003
Why it stopped: No participants enrolled, study terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Donald A Podoloff, M.D., Study chair, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00038038
- Sponsor's protocol ID
- ID93-028
- Status last verified
- Jul 2012
- First submitted
- 24 May 2002
- Last updated
- 1 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Head and Neck Tumor Hypoxia Using 18F-Fluoromisonidazole
- ClinicalTrials.gov ID
- NCT00038038
- Acronym / sponsor ID
- ID93-028
- Keywords
- Squamous cell carcinoma of head and neck
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled, study terminated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Jan 1994
- Primary completion
- Jun 2003 (actual)
- Study completion
- Jun 2003 (actual)
- First posted
- 27 May 2002 (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.
The purpose of this clinical research study is to answer the following questions using 18F-fluoromisonidazole as an imaging agent:
- Do cells exist in human tumors that are at very low oxygen levels (hypoxic cells)?
- If hypoxic cells exist in human tumors, do they effect the ability of radiotherapy to control human tumors?
- Can Positron Emission Tomography (PET scanning) detect hypoxic cells in human tumors?
Detailed description
Hypoxic (low oxygen) cells have long been known to exist in animal tumors. It is also known that hypoxic cells are more difficult to eliminate with radiotherapy than tumor cells at normal levels of oxygen (normoxic cells). However, the extent to which hypoxic cells limit the curability of human tumors is uncertain. To determine if hypoxic cells exist in human tumors and how hypoxic cells might influence the efficacy of radiotherapy, this study involves direct measurements of oxygen levels in human tumors compared to the tumor uptake of the experimental drug, 18F-fluoromisonidazole (18F-FMISO), visualized with PET scanning. 18F-fluoromisonidazole has been used with PET imaging to tell the difference between growing tumors which have high and low oxygen content.
Before beginning radiotherapy, a PET scan (series of pictures, 20 min. scan) will be performed at 2 hours after an intravenous injection of a small amount of radioactive traces drug, 18F-fluoromisonidazole (18F-FMISO) to observe the active hypoxia tumors areas. Upon completion of the 18F-FMISO PET scan, direct oxygen measurements will be obtained by placing a small needle into the tumor under computer tomographic (CT) guidance. The PET scan and needle measurements will be repeated every 4 weeks into the course of radiotherapy and again after the completion of radiotherapy. The measurement obtained by 18F-FMISO PET scanning (non-invasive technique) and by direct needle measurements (invasive technique) will be correlated with the eventual treatment outcome for future use.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET + 18F-fluoromisonidazole | Experimental | Drug: 18F-fluoromisonidazole, Procedure: PET scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Histologically proven squamous cell carcinoma of head and neck wth metastatic neck nodes greater than or equal to 2cm
- Karnofsky performance status greater or equal to 60%
Key exclusion criteria (6 listed)
- No prior irradiation or surgery to head/neck area
- No prior chemotherapy within 1 month of participation and have recovered from associated related effects
- Not pregnant
- Any intercurrent medical or physiologic disorder which would prevent informed consent
- Underlying medical problems which would compromise technical ability to deliver a "standard course" of radiation therapy
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-fluoromisonidazoleAlso: 18F-FMISOSmall amount of radioactive traces drug given by intravenous injection prior to PET Scan | Drug | PET + 18F-fluoromisonidazole |
| PET scanSeries of pictures using 20 minute scan performed 2 hours after an 18F-fluoromisonidazole injection | Procedure or surgery | PET + 18F-fluoromisonidazole |
Primary outcome
Direct Oxygen Measurements
Time frame: PET scan and needle measurements will be repeated every 4 weeks into the course of radiotherapy and again after the completion of radiotherapy.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2012.
- UT MD Anderson Cancer Center websiteLink 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.
Donald A Podoloff, M.D. study chair
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-fluoromisonidazole and PET scan in people with Squamous Cell Carcinoma and Head and Neck Neoplasms, run by M.D. Anderson Cancer 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?
The sponsor lists 2 inclusion and 6 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: withdrawn, as of the sponsor's last update on 1 Aug 2012. 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 was withdrawn before enrolling participants, so there are no results.
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?
Direct Oxygen Measurements (time frame: PET scan and needle measurements will be repeated every 4 weeks into the course of radiotherapy and again after the completion of radiotherapy.). 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 1 Aug 2012.