Clinical trial for IDH Wild Type Glioblastoma
Official title Feasibility of FMISO in Brain Tumors
ClinicalTrials.gov ID: NCT03649880
What this study is testing
What is ¹⁸F-Fluoromisonidazole?
¹⁸F-Fluoromisonidazole is an investigational medicine, given as an IV infusion (through a vein), being studied as a potential treatment for idh wild type glioblastoma.
Also referred to as ¹⁸F-MISO, ¹⁸F-Misonidazole.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether FMISO PET/MRI can show oxygen levels in brain tumors. It looks at how useful the scan is for people with IDH wild type glioblastoma.
- Who it's for
- You may be able to join if you have IDH wild type glioblastoma and are willing to have scans.
- What's involved
- You will receive a small amount of FMISO and have PET and MRI scans. Some MRI scans use liquid dyes called gadolinium or ferumoxytol given through a vein.
- Time commitment
- The study lasts a few weeks and includes several imaging visits during that time.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 5 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult patients (18 years of age and older) with a clinically suspected glioma
- Able to provide informed written consent and/or acceptable surrogate capable of providing consent on the patient's behalf
- Legally authorized representative (LAR)-signed informed consent and assent obtained for those people identified as decisionally impaired
- Intracranial disease greater than 5 mL as assessed by T2/fluid attenuated inversion recovery (FLAIR) MR imaging
- Karnofsky performance score \> 60 or Eastern Cooperative Oncology Group (ECOG) \< 3 as assessed by referring clinician.
You likely can't join if
- Pregnant or breastfeeding.
- Contraindication to PET, MRI, FMISO, ferumoxytol, or intravenous gadolinium based contrast agents.
- Claustrophobia is not controlled with medical therapy
- Weight is greater than modality maximum capacity.
- Presence of metallic foreign body or implanted medical devices in body not documented as MRI safe according to the Oregon Health \& Science...
- people with family history of or known iron overload (genetic hemochromatosis).
See the full eligibility criteria
- Adult patients (18 years of age and older) with a clinically suspected glioma
- Able to provide informed written consent and/or acceptable surrogate capable of providing consent on the patient's behalf
- Legally authorized representative (LAR)-signed informed consent and assent obtained for those people identified as decisionally impaired
- Intracranial disease greater than 5 mL as assessed by T2/fluid attenuated inversion recovery (FLAIR) MR imaging
- Karnofsky performance score \> 60 or Eastern Cooperative Oncology Group (ECOG) \< 3 as assessed by referring clinician.
- Either has previously received therapeutic intervention for an intracranial tumor or is eligible for and agreeable to receiving standard of care stupp protocol radiation and temozolomide after biopsy or maximum safe...
- Life expectancy of at least 6 months
- Female subject of childbearing potential will be asked for possibility of pregnancy. If unsure of pregnancy status, then a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study...
- Adequate organ function as demonstrated by a chart review of platelets, renal, hepatic, and coagulation.
- Pregnant or breastfeeding.
- Contraindication to PET, MRI, FMISO, ferumoxytol, or intravenous gadolinium based contrast agents.
- Claustrophobia is not controlled with medical therapy
- Weight is greater than modality maximum capacity.
- Presence of metallic foreign body or implanted medical devices in body not documented as MRI safe according to the Oregon Health \& Science University (OHSU) Department of Radiology guidelines (including but not limited...
- people with family history of or known iron overload (genetic hemochromatosis).
- Subject who have received ferumoxytol within 3 weeks of study entry and require another ferumoxytol administration.
- people with three or more drug allergies from separate drug classes.
- History of hypersensitivity allergic reactions attributed to compounds of similar chemical or biologic composition to FMISO. An allergic reaction to nitroimidazoles is highly unlikely.
- Sickle cell disease.
- History of hypersensitivity allergic reactions attributed to compounds of similar chemical or biologic composition to ferumoxytol or gadolinium MRI contrast
- Unsure of pregnancy status as assessed by Department of Radiology and AIRC guidelines.
- people for whom supplemental oxygen could be harmful such as people with potential for hypoventilation (end-stage chronic obstructive pulmonary disease [COPD], obstructive sleep apnea [OSA] on continuous positive airway...
- Presence of any other co-existing condition that, in the judgment of the principal investigator, might increase the risk to the subject (i.e., plans for hospice or end of life care).
- Poor peripheral intravenous access evaluated by patient history.
- Presence of other serious systemic illnesses, including: uncontrolled infection, other uncontrolled malignancy, uncontrolled diabetes type II, or psychiatric/social situations which might impact the endpoint of the...
The study team makes the final eligibility decision.
Where it is enrolling
- Portland, Oregon, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Portland, Oregon, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.