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Assessment of Primary and Metastatic Brain Tumor Hypoxia With Fluoromisonidazole, FDG and Water

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ClinicalTrials.gov Identifier: NCT01246869
Recruitment Status : Recruiting
First Posted : November 23, 2010
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
University of Utah

Tracking Information
First Submitted Date November 1, 2010
First Posted Date November 23, 2010
Last Update Posted Date August 26, 2019
Study Start Date August 2011
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 22, 2010)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Assessment of Primary and Metastatic Brain Tumor Hypoxia With Fluoromisonidazole, FDG and Water
Official Title Assessment of Primary and Metastatic Brain Tumor Hypoxia With 18F-Fluoromisonidazole, [18F]Fluoro-2-deoxy-D-glucose (FDG) and [15O]Water (H215O)
Brief 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 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 H2O (water) 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:

  1. 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-SUV, FDG quantitative parameters and blood flow as well as MR (magnetic resonance) perfusion and blood volume will be assessed to see if they correlate with survival and time to progression.
  2. 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.
  3. 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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Study patients: Adult patients (18 years or older) with glial neoplasms or brain metastasis. We expect that up to 40 total people may be enrolled in this study. This will assure that 30 evaluable patients (patients who have complete imaging results and blood data available for data analysis).
Condition Brain Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 22, 2010)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2021
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. 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)
  2. Patients must be 18 years or older for inclusion in this research study.
  3. Patients must document their willingness to be followed until death or time of progression.
  4. All patients must sign a written informed consent and HIPAA authorization in accordance with institutional guidelines.
  5. Female patients who are not postmenopausal or surgically sterile will undergo a serum pregnancy test prior to the research PET scans.
  6. Pre-treatment laboratory tests for patients receiving [18F]FMISO must be performed within 21 days prior to study entry.

Exclusion Criteria:

  1. Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals.
  2. Patients who are pregnant or lactating or who suspect they might be pregnant.
  3. Adult patients who require monitored anesthesia for PET scanning.
  4. Patients who are too claustrophobic to undergo MRI or PET imaging
  5. Patients who cannot undergo MRI imaging due to MRI exclusion criteria
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: John M Hoffman, MD 801-581-4064 john.hoffman@hci.utah.edu
Contact: Paige Nielsen 801-585-5942 paige.nielsen@hci.utah.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01246869
Other Study ID Numbers HCI44704
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Utah
Study Sponsor University of Utah
Collaborators Not Provided
Investigators
Principal Investigator: John M Hoffman, MD University of Utah
PRS Account University of Utah
Verification Date August 2019