Brain CancerPhase 1NCT01246869
Assessment of Primary and Metastatic Brain Tumor Hypoxia With Fluoromisonidazole, FDG and Water
A Phase 1 study testing [18F]fluoro-2-deoxy-D-glucose (FDG), 1H-1-(3-[18F]-fluoro-2-hydroxy-propyl)-2-nitro-imidazole [18F]-fluoromisonidazole and [15O]water in people with Brain Cancer, run by University of Utah at 1 site in United States.
Trial summary
Purpose of Study This exploratory clinical study will investigate FMISO (fluoromisonidazole) in patients with (1) newly diagnosed primary malignant brain tumors (WHO [World Health Organization] Grade III or IV glial-based tumors) who have not had a complete surgical resection and by contrast MRI (Magnetic resonance… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Cancer
- What is being tested?
- [18F]fluoro-2-deoxy-D-glucose (FDG), 1H-1-(3-[18F]-fluoro-2-hydroxy-propyl)-2-nitro-imidazole [18F]-fluoromisonidazole and [15O]water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2013to 3 May 2014
- Phase
- Phase 1
- 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
- Adult patients. The patient must have a newly diagnosed primary malignant brain tumors (WHO Grade III or IV glial-based tumors) and not have had a complete surgical resection and by contrast MRI (obtained within 14 days prior to the FMISO study)
- Patients must be 18 years or older for inclusion in this research study.
- Patients must document their willingness to be followed until death or time of progression.
- All patients must sign a written informed consent and HIPAA authorization in accordance with institutional guidelines.
- Female patients who are not postmenopausal or surgically sterile will undergo a serum pregnancy test prior to the research PET scans.
- Pre-treatment laboratory tests for patients receiving [18F]FMISO must be performed within 21 days prior to study entry.
Who cannot join
- Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals.
- Patients who are pregnant or lactating or who suspect they might be pregnant.
- Adult patients who require monitored anesthesia for PET scanning.
- Patients who are too claustrophobic to undergo MRI or PET imaging
- Patients who cannot undergo MRI imaging due to MRI exclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
About this study
Official title: Assessment of Primary and Metastatic Brain Tumor Hypoxia With 18F-Fluoromisonidazole, [18F]Fluoro-2-deoxy-D-glucose (FDG) and [15O]Water (H215O)
Purpose of Study This exploratory clinical study will investigate FMISO (fluoromisonidazole) in patients with (1) newly diagnosed primary malignant brain tumors (WHO [World Health Organization] Grade III or IV glial-based tumors) who have not had a complete surgical resection and by contrast MRI (Magnetic resonance imaging) have residual tumor > 1.0 cm in diameter and will be receiving radiotherapy or (2) newly diagnosed brain metastasis (> 1.0 cm in diameter who will be receiving radiotherapy. The ability to accurately assess tumor hypoxia and accurately determine the amount/degree of tumor hypoxia could potentially change patient management once validated as tumor hypoxia is known to be associated with a poor prognosis [Eyler 2008].
Read the detailed description
Malignant Brain Tumors (Primary and Metastatic) Despite significant advances in the understanding of brain tumor biology and genetics as well as improvements in surgical techniques, radiotherapy administration, and chemotherapy methods, many brain tumors remain incurable. Many brain tumors are highly infiltrative neoplasms, and are therefore unlikely to be cured by local treatments such as surgery, focal radiotherapy, radiosurgery or brachytherapy.
Rationale and Goals of Study The preliminary efficacy of the radiopharmaceutical, 1H-1-(3-[18F]-fluoro-2-hydroxy-propyl)-2-nitro-imidazole [18F]-fluoromisonidazole, [18F]FMISO, FMISO (fluoromisonidazole), a radiopharmaceutical that directly assess tumor hypoxia using Positron Emission Tomography(PET) will be assessed.
This preliminary/exploratory clinical study will investigate [F-18]FMISO in 30 evaluable patients with newly diagnosed primary brain tumor or brain metastasis. We expect that up to 35 -40 total patients may be enrolled in this study. This will assure that 30 evaluable patients (patients who have complete imaging results and blood metabolism data available for data analysis). In certain patients the blood metabolism data is not acceptable for final analysis typically due to difficulty in drawing it rapidly enough due to the vein collapsing during the rapid sampling required.
When possible we will also correlate FMISO uptake with the typical in-vitro test used to assess proliferation, Ki-67 (protein) and other experimental assessments of hypoxia. This correlation will be made whenever possible in those patients where tumor tissue is obtained as part of standard care.
OBJECTIVES:
Primary Objective of Study - Synopsis The primary objective of this study is to determine the association of FMISO PET (positron emission tomography) uptake (hypoxic volume (HV)), highest tumor:blood ratio [T/Bmax]), FDG ([18F]-2 fluoro-2-deoxy-d-glucose) uptake, and tumor blood flow/perfusion determined with water (H2O) and MRI and correlate these variables with overall survival (OS) and time to progression (TTP) in participants with newly diagnosed primary brain tumors or brain metastases.
The Hypotheses to be Tested
Three exploratory hypotheses will be studied. These include:
- The first hypothesis to be tested is that increased FMISO PET uptake (hypoxic volume [HV], highest tumor:blood ratio [T/Bmax]) is correlated with a shorter overall survival and a shorter time to progression. An exploratory evaluation assessing combinations of PET imaging variables such as hypoxic volume [HV], highest tumor:blood ratio [T/Bmax], FDG-standardized uptake value (SUV), FDG quantitative parameters and blood flow as well as magnetic resonance (MR) perfusion and blood volume will be assessed to see if they correlate with survival and time to progression.
- A second hypothesis to be tested is that FMISO is safe and non toxic in the dose administered in this study in patients with primary and metastatic brain tumors. This will be assessed in the first 10 patients enrolled in the study. Even though there have been numerous published studies using FMISO in humans in several different tumor types little human safety data has been published. Laboratory tests (except urinalysis) will be repeated at approximately 24 hours in the first 10 and compared to the screening values.
- A third exploratory hypothesis to be tested is that FMISO uptake (hypoxic volume [HV], highest tumor:blood ratio [T/Bmax]) will correlate with increased FDG uptake and possibly with reduced blood flow/perfusion as determined with H215O PET imaging and MRI
- Conditions
- Brain Cancer
- Being tested
- [18F]fluoro-2-deoxy-D-glucose (FDG), 1H-1-(3-[18F]-fluoro-2-hydroxy-propyl)-2-nitro-imidazole [18F]-fluoromisonidazole, [15O]water, Magnetic Resonance Imaging
- Keywords
- brain, cancer,glioblastoma multiforme, meningioma, glioma
- Medical subject headings
- Brain Neoplasms, Neoplasms, Glioblastoma, Meningioma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]fluoro-2-deoxy-D-glucose (FDG)Drug
Also called FDG, [18F]FDG, FDG-PET/CT
Brain scan with imaging tracer used for measuring glucose metabolism in the assessment, diagnosis, and staging of patients with cancer
1H-1-(3-[18F]-fluoro-2-hydroxy-propyl)-2-nitro-imidazole [18F]-fluoromisonidazoleDrug
Also called [18F]FMISO, FMISO, FMISO-PET/CT
Brain scan with radiopharmaceutical imaging tracer that directly assesses tumor hypoxia
[15O]waterDrug
Also called H2[15O], H2[15O]-PET-CT
Brain scan with imaging tracer used for measuring tumor blood flow/perfusion
Magnetic Resonance ImagingDiagnostic test
Also called MRI
Brain scan to assess tumor size and tumor blood flow/perfusion
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Experimental | All enrolled participants will complete three imaging sessions on separate days, beginning with a research MRI, then a PET scan with FDG and [15O]water, and a PET scan with FMISO. The two PET scans will be in any order on different days within one week of each other, and preferably on consecutive days. The research MRI will be within 14 days of the first PET scan. Receives: Drug: [18F]fluoro-2-deoxy-D-glucose (FDG); Drug: 1H-1-(3-[18F]-fluoro-2-hydroxy-propyl)-2-nitro-imidazole [18F]-fluoromisonidazole; Drug: [15O]water; Diagnostic Test: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of multi-tracer update times as related to overall survival and time to progression
determine the association of FMISO PET uptake (hypoxic volume [HV]), highest tumor:blood ratio [T/Bmax]), FDG uptake, and tumor blood flow/perfusion determined with H215O and MRI and correlate these variables with overall survival (OS) and time to progression (TTP) in participants with newly diagnosed primary brain tumors or brain metastases.
Measured: estimated 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2010 (estimated)
- Study start27 Mar 2013
- Primary completion3 May 2014
- Study completion3 May 2014
Why it stopped: PI retired, study closed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain CancerStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey Yap, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01246869
- Sponsor's protocol ID
- HCI44704
- Status last verified
- Sep 2024
- First submitted
- 1 Nov 2010
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Primary and Metastatic Brain Tumor Hypoxia With 18F-Fluoromisonidazole, [18F]Fluoro-2-deoxy-D-glucose (FDG) and [15O]Water (H215O)
- ClinicalTrials.gov ID
- NCT01246869
- Acronym / sponsor ID
- HCI44704
- Conditions
- Brain Cancer
- Keywords
- brain, cancer,glioblastoma multiforme, meningioma, glioma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI retired, study closed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 27 Mar 2013 (actual)
- Primary completion
- 3 May 2014 (actual)
- Study completion
- 3 May 2014 (actual)
- First posted
- 23 Nov 2010 (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.
Purpose of Study This exploratory clinical study will investigate FMISO (fluoromisonidazole) in patients with (1) newly diagnosed primary malignant brain tumors (WHO [World Health Organization] Grade III or IV glial-based tumors) who have not had a complete surgical resection and by contrast MRI (Magnetic resonance imaging) have residual tumor > 1.0 cm in diameter and will be receiving radiotherapy or (2) newly diagnosed brain metastasis (> 1.0 cm in diameter who will be receiving radiotherapy. The ability to accurately assess tumor hypoxia and accurately determine the amount/degree of tumor hypoxia could potentially change patient management once validated as tumor hypoxia is known to be associated with a poor prognosis [Eyler 2008].
Detailed description
Malignant Brain Tumors (Primary and Metastatic) Despite significant advances in the understanding of brain tumor biology and genetics as well as improvements in surgical techniques, radiotherapy administration, and chemotherapy methods, many brain tumors remain incurable. Many brain tumors are highly infiltrative neoplasms, and are therefore unlikely to be cured by local treatments such as surgery, focal radiotherapy, radiosurgery or brachytherapy.
Rationale and Goals of Study The preliminary efficacy of the radiopharmaceutical, 1H-1-(3-[18F]-fluoro-2-hydroxy-propyl)-2-nitro-imidazole [18F]-fluoromisonidazole, [18F]FMISO, FMISO (fluoromisonidazole), a radiopharmaceutical that directly assess tumor hypoxia using Positron Emission Tomography(PET) will be assessed.
This preliminary/exploratory clinical study will investigate [F-18]FMISO in 30 evaluable patients with newly diagnosed primary brain tumor or brain metastasis. We expect that up to 35 -40 total patients may be enrolled in this study. This will assure that 30 evaluable patients (patients who have complete imaging results and blood metabolism data available for data analysis). In certain patients the blood metabolism data is not acceptable for final analysis typically due to difficulty in drawing it rapidly enough due to the vein collapsing during the rapid sampling required.
When possible we will also correlate FMISO uptake with the typical in-vitro test used to assess proliferation, Ki-67 (protein) and other experimental assessments of hypoxia. This correlation will be made whenever possible in those patients where tumor tissue is obtained as part of standard care.
OBJECTIVES:
Primary Objective of Study - Synopsis The primary objective of this study is to determine the association of FMISO PET (positron emission tomography) uptake (hypoxic volume (HV)), highest tumor:blood ratio [T/Bmax]), FDG ([18F]-2 fluoro-2-deoxy-d-glucose) uptake, and tumor blood flow/perfusion determined with water (H2O) and MRI and correlate these variables with overall survival (OS) and time to progression (TTP) in participants with newly diagnosed primary brain tumors or brain metastases.
The Hypotheses to be Tested
Three exploratory hypotheses will be studied. These include:
- The first hypothesis to be tested is that increased FMISO PET uptake (hypoxic volume [HV], highest tumor:blood ratio [T/Bmax]) is correlated with a shorter overall survival and a shorter time to progression. An exploratory evaluation assessing combinations of PET imaging variables such as hypoxic volume [HV], highest tumor:blood ratio [T/Bmax], FDG-standardized uptake value (SUV), FDG quantitative parameters and blood flow as well as magnetic resonance (MR) perfusion and blood volume will be assessed to see if they correlate with survival and time to progression.
- A second hypothesis to be tested is that FMISO is safe and non toxic in the dose administered in this study in patients with primary and metastatic brain tumors. This will be assessed in the first 10 patients enrolled in the study. Even though there have been numerous published studies using FMISO in humans in several different tumor types little human safety data has been published. Laboratory tests (except urinalysis) will be repeated at approximately 24 hours in the first 10 and compared to the screening values.
- A third exploratory hypothesis to be tested is that FMISO uptake (hypoxic volume [HV], highest tumor:blood ratio [T/Bmax]) will correlate with increased FDG uptake and possibly with reduced blood flow/perfusion as determined with H215O PET imaging and MRI
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | Experimental | Drug: [18F]fluoro-2-deoxy-D-glucose (FDG), Drug: 1H-1-(3-[18F]-fluoro-2-hydroxy-propyl)-2-nitro-imidazole [18F]-fluoromisonidazole, Drug: [15O]water, Diagnostic Test: Magnetic Resonance ImagingAll enrolled participants will complete three imaging sessions on separate days, beginning with a research MRI, then a PET scan with FDG and [15O]water, and a PET scan with FMISO. The two PET scans will be in any order on different days within one week of each other, and preferably on consecutive days. The research MRI will be within 14 days of the first PET scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients. The patient must have a newly diagnosed primary malignant brain tumors (WHO Grade III or IV glial-based tumors) and not have had a complete surgical resection and by contrast MRI (obtained within 14 days prior to the FMISO study)
- Patients must be 18 years or older for inclusion in this research study.
- Patients must document their willingness to be followed until death or time of progression.
- All patients must sign a written informed consent and HIPAA authorization in accordance with institutional guidelines.
- Female patients who are not postmenopausal or surgically sterile will undergo a serum pregnancy test prior to the research PET scans.
Key exclusion criteria (5 listed)
- Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals.
- Patients who are pregnant or lactating or who suspect they might be pregnant.
- Adult patients who require monitored anesthesia for PET scanning.
- Patients who are too claustrophobic to undergo MRI or PET imaging
- Patients who cannot undergo MRI imaging due to MRI exclusion criteria
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]fluoro-2-deoxy-D-glucose (FDG)Also: FDG, [18F]FDG, FDG-PET/CTBrain scan with imaging tracer used for measuring glucose metabolism in the assessment, diagnosis, and staging of patients with cancer | Drug | All Participants |
| 1H-1-(3-[18F]-fluoro-2-hydroxy-propyl)-2-nitro-imidazole [18F]-fluoromisonidazoleAlso: [18F]FMISO, FMISO, FMISO-PET/CTBrain scan with radiopharmaceutical imaging tracer that directly assesses tumor hypoxia | Drug | All Participants |
| [15O]waterAlso: H2[15O], H2[15O]-PET-CTBrain scan with imaging tracer used for measuring tumor blood flow/perfusion | Drug | All Participants |
| Magnetic Resonance ImagingAlso: MRIBrain scan to assess tumor size and tumor blood flow/perfusion | Diagnostic test | All Participants |
Primary outcome
Determination of multi-tracer update times as related to overall survival and time to progression
Time frame: estimated 2 years
determine the association of FMISO PET uptake (hypoxic volume [HV]), highest tumor:blood ratio [T/Bmax]), FDG uptake, and tumor blood flow/perfusion determined with H215O and MRI and correlate these variables with overall survival (OS) and time to progression (TTP) in participants with newly diagnosed primary brain tumors or brain metastases.
Results and safety
The study was stopped early (reason given: PI retired, study closed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
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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.
Jeffrey Yap, PhD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [18F]fluoro-2-deoxy-D-glucose (FDG), 1H-1-(3-[18F]-fluoro-2-hydroxy-propyl)-2-nitro-imidazole [18F]-fluoromisonidazole and [15O]water in people with Brain Cancer, run by University of Utah 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 6 inclusion and 5 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 1 Oct 2024. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: PI retired, study closed). 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?
Determination of multi-tracer update times as related to overall survival and time to progression (time frame: estimated 2 years). 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 Oct 2024.