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

• Status: Terminated
• Trial end date: 2023-01-20
• Target enrollment: 0
• Participant gender: All

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].

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah
• Treatments: Deoxyglucose; Imidazole

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