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

NCT01246869 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: HCI44704
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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 \[Eyler 2008\].

Conditions

Brain Cancer

Keywords

brain, cancer,glioblastoma multiforme, meningioma, glioma

Outcome Measures

Primary Outcomes (1)

• 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.

  estimated 2 years

Study Arms (1)

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.

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

Interventions

[18F]fluoro-2-deoxy-D-glucose (FDG) DRUG

Brain scan with imaging tracer used for measuring glucose metabolism in the assessment, diagnosis, and staging of patients with cancer

Also known as: FDG, [18F]FDG, FDG-PET/CT

All Participants

1H-1-(3-[18F]-fluoro-2-hydroxy-propyl)-2-nitro-imidazole [18F]-fluoromisonidazole DRUG

Brain scan with radiopharmaceutical imaging tracer that directly assesses tumor hypoxia

Also known as: [18F]FMISO, FMISO, FMISO-PET/CT

All Participants

[15O]water DRUG

Brain scan with imaging tracer used for measuring tumor blood flow/perfusion

Also known as: H2[15O], H2[15O]-PET-CT

All Participants

Magnetic Resonance Imaging DIAGNOSTIC_TEST

Brain scan to assess tumor size and tumor blood flow/perfusion

Also known as: MRI

All Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Brain Neoplasms; Neoplasms; Glioblastoma; Meningioma; Glioma

Interventions

Fluorodeoxyglucose F18; fluoromisonidazole; Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Astrocytoma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms, Vascular Tissue; Meningeal Neoplasms

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Jeffrey Yap, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2010
• First Posted: November 23, 2010
• Study Start: March 27, 2013
• Primary Completion: May 3, 2014
• Study Completion: May 3, 2014
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

US (1)