Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2025-12-24 @ 10:59 PM
NCT ID:
NCT01246869
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01246869
Study Brief:
Protocol Section:
NCT01246869