An Early Phase 1 interventional study of [18F]FMISO-PET with contrast-enhanced MRI in Glioma, sponsored by University of Alabama at Birmingham. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by University of Alabama at Birmingham · Early Phase 1, Interventional, and Diagnostic
Among 851 studies in Glioma with a site in United States — 143 open to participants now, 229 under way, 6 of them phase 3. Glioma · United States.
Among the 851 studies in Glioma with a site in United States, this one is the 448th largest by planned enrollment of the 737 interventional ones that give a count, is one of 38 that started in 2026, is one of 338 in phase 1, reaches primary completion later than 210 of the 228 other live ones, and was the 844th registered.
1,452 studies on the registry are indexed under Glioma; 349 are open to participants now.
Browse Glioma studies →143 of the 851 studies in Glioma with a site in United States are open now. Recruiting first, the newest first:
Nuvation Bio Inc. · Sites in United States
Ages 18+
Children's Hospital of Philadelphia · Sites in United States
Ages 1–21
Beijing Inno Medicine Co., Ltd. · Sites in United States, China
Ages 18–70
Neonc Technologies, Inc. · Sites in United States
Ages 5–18
Children's National Research Institute · Sites in United States
Ages 3–25
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 267 Glioma studies recruiting now, 164 (61%) set no upper age limit and 57 (21%) stop at 75 or younger; 63 take children under 18; 15 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
851 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 430 · Phase 2 320 · Phase 3 21 · Phase 4 6
First in 1979; this study’s year is marked. 38 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 20 is below the median of 32 across 1,075 interventional studies indexed under Glioma.
Median enrollment 30 across the 737 interventional studies, 69 across the 77 observational. Of the 564 that completed or were terminated, 203 (36%) have results posted.
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172 of 851 have an industry lead sponsor. The 10 most frequent:
University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
University of Alabama at Birmingham has 9 studies filed under Glioma — fewer than ten, so there is no comparison to draw.
88 of the studies in Glioma with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT00978458Phase 3Eastern Cooperative Oncology GroupRadiation Therapy With or Without Temozolomide in Treating Patients With Low-Grade Glioma | 2026-12-31 |
| NCT05271240Phase 3Northwell HealthRepeated Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab With Temozolomide and Radiation Compared to Temozolomide and Radiation Alone in Newly Diagnosed GBM | 2027-04-01 |
| NCT07814872Harvard Medical School (HMS and HSDM)A Preregistered Multi-Cohort Evaluation of the FATHOM AI System for Molecular Testing Prioritization to Support Clinical Trial Enrollment | 2026-11 |
| NCT03510208Stanford UniversityPanitumumab-IRDye800 in Diagnosing Participants With Malignant Glioma Undergoing Surgery | 2026-11 |
| NCT05094336AmgenA Study of Anvumetostat in Participants With Advanced MTAP-null Solid Tumors (MTAPESTRY 101) | 2026-11-30 |
Add all 88 to your calendar (.ics) → With an account.
Among the 851 studies in Glioma with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This substudy will investigate a new imaging approach using positron emission tomography (PET) and two investigational drugs ([18F]FET and [18F]FMISO) to see if the imaging results will help with the placement of catheters for therapy delivery in 20 adult patients with malignant gliomas (MGs) who are participating in the UAB IRB approved main study, A Phase I/II Study of Pembrolizumab and M032 (NSC 733972), a Genetically Engineered HSV-1 Expressing IL-12, in Patients with Recurrent/Progressive and Newly Diagnosed Glioblastoma Multiforme, grade 3 or grade 4 astrocytoma, or Gliosarcoma (IRB 300007756 PI Markert). The PET and MR imaging results will be available to guide catheter placement within IRB 300007756 study-specific guidelines during Neurosurgery.
Pre-Study Consent Visit
This visit will take 0.5 hours and may take place during your neuro-oncology clinic visit or in the Division of Molecular Imaging and Therapeutics in Jefferson Tower or the Wallace Tumor Institute. Participants will be asked to sign this consent form before any study procedures. Participants will have a blood test to measure their kidney function. If participants have already had lab tests to determine kidney function within 4 weeks, they do not have to be repeated. Women of childbearing potential will have a urine pregnancy test or have had a blood test within 48 hours of consenting. If the participant is eligible, they will be scheduled to return for baseline imaging within 21 days before surgery.
Once consented, participants will fill out an MRI screening questionnaire in person or through a screening phone call. These questions will help identify and address items like claustrophobia. If participants are anxious or claustrophobic (anxious due to being in a confined area) due to the PET/MRI imaging procedures, a study physician will call in lorazepam (Ativan), 0.5 mg-1 mg based on individual patient assessment, to a pharmacy of the participants choice. One tablet is to be taken with each imaging visit as necessary. Participants will be responsible for paying for the medication and the study will not reimburse them. Participants will need to pick up the medication and bring it with them to each study visit. This medication may make participants drowsy, and they should not drive for 12 hours after taking this medication. Participants must make arrangements to have a responsible adult present to provide them with transportation home after each visit. Participants should also avoid drinking alcohol or taking opioid pain medications for at least 12 hours or use dangerous equipment after taking this medication. Additional FDA information will be given to participants during this visit describing this medication and known side effects.
Baseline Imaging (performed within 21 days of surgery)
Participants will be scheduled to have baseline imaging performed during one or two separate days based on their preference and scanner and drug production availability.
DAY - Baseline Combo FMISO/FET-PET/MRI Imaging Visit
If participants are scheduled for baseline imaging performed during one (1) day, this visit will take about 6.5 hours. Participants will be asked to not eat or drink anything with calories for 4 hours prior to the study. When participants arrive at the Advanced Imaging Facility (AIF), located in the Wallace Tumor Institute (WTI), they will have another chance to have any questions answered about the procedure.
If participants have been prescribed lorazepam to help reduce anxiety, the study coordinator will verify they have a driver and/or transportation present. Participants will take 1 tablet by mouth upon arrival or at least one hour before the imaging procedure.
Female participants of childbearing potential will have either a blood draw or urine pregnancy test within 48 hours before administration of the radioactive drug to make sure they are not pregnant.
Before the scan, participants will have a plastic catheter inserted into a vein in each arm. Participants will be injected with [18F]FMISO and they will wait 4 hours for the drug to distribute in the body. Participants will then be positioned in the PET/MRI scanner and scanned for up to 30 minutes during which time they will receive an injection of gadolinium MR contrast agent.
Immediately following the FMISO-PET/MRI imaging, participants will receive an injection of [18F]FET and will be imaged for another 40 minutes.
Participants will be monitored during the imaging to make sure they are not experiencing any side effects and those taking lorazepam will be monitored for confusion or disorientation.
When participants have completed the PET/MRI imaging, the catheters will be removed, and they may resume normal activities.
Participants will receive a follow-up phone call within 48 hours of their imaging visit. Participants will be asked about any changes in their health and side effects that might be due to the investigational drug.
If participants are scheduled for baseline imaging to be performed over two (2) separate days, every effort will be made to schedule these two visits within 1 week (7 days) of each other. One visit will take 2 hours and the other will take 5 hours. FET-PET/MRI will typically be performed first although the order can be switched if needed due to drug production or scanner availability.
FET-PET/MRI imaging - baseline visit (2-Day)
This visit will take about 2 hours. Participants will be asked to not eat or drink anything with calories for 4 hours prior to the study. When participants arrive at the Advanced Imaging Facility (AIF), located in the Wallace Tumor Institute (WTI), they will have another chance to have any questions answered about the procedure.
If participants have been prescribed lorazepam to help reduce anxiety, the study coordinator will verify they have a driver and/or transportation present. participants will take 1 tablet by mouth upon arrival or at least one hour before the imaging procedure.
Female participants of childbearing potential will have either a blood draw or urine pregnancy test within 48 hours before administration of the radioactive drug to make sure they are not pregnant.
Before the scan, participants will have a plastic catheter inserted into a vein in one or both arm(s) and positioned in the PET/MRI. Participants will be injected with [18F]FET and imaged for up to 40 minutes during which time they will receive an injection of gadolinium MR contrast agent.
Participants will be monitored during the imaging to make sure they are not experiencing any side effects and those taking lorazepam will be monitored for confusion or disorientation.
When participants have completed the PET/MRI imaging, the catheters will be removed, and they may resume normal activities.
Participants will receive a follow-up phone call within 48 hours of their imaging visit. Participants will be asked about any changes in their health and side effects that might be due to the investigational drug.
FMISO-PET/MRI imaging - baseline visit (2-Day)
This visit will take up to 5 hours. No fasting or other special preparation is required for this visit. When participants arrive at the Advanced Imaging Facility (AIF), located in the Wallace Tumor Institute (WTI), they will have another chance to have any questions answered about the procedure.
If participants have been prescribed lorazepam to help reduce anxiety, the study coordinator will verify they have a driver and/or transportation present. participants will take 1 tablet by mouth upon arrival or at least one hour before the imaging procedure.
Female participants of childbearing potential will have either a blood draw or urine pregnancy test within 48 hours before administration of the radioactive drug to make sure they are not pregnant.
Before the scan, participants will have a plastic catheter inserted into a vein in one or both arms. Participants will be injected with [18F]FMISO and they will wait 4 hours for the drug to distribute in the body. Participants will then be positioned in the PET/MRI scanner and scanned for up to 30 minutes during which time they will receive an injection of gadolinium MR contrast agent.
Participants will be monitored during the imaging to make sure they are not experiencing any side effects and those taking lorazepam will be monitored for confusion or disorientation.
When participants have completed the PET/MRI imaging, the catheters will be removed, and they may resume normal activities.
Participants will receive a follow-up phone call within 48 hours of their imaging visit. Participants will be asked about any changes in their health and side effects that might be due to the investigational drug.
Post Surgery Follow up FET-PET/MRI visits
After the participant's surgery as directed under the main study (IRB 300007756), they will be scheduled for follow-up FET-PET/MRI imaging at approximately 1 month, 3 months and 6-8 months.
Each of these visits will take about 2 hours. Participants will be asked to not eat or drink anything with calories for 4 hours prior to each imaging visit.
If participants have been prescribed lorazepam to help reduce anxiety, the study coordinator will verify they have a driver and/or transportation present. participants will take 1 tablet by mouth upon arrival or at least one hour before the imaging procedure.
Female participants of childbearing potential will have either a blood draw or urine pregnancy test within 48 hours before administration of the radioactive drug to make sure they are not pregnant.
Before the scan, participants will have a plastic catheter inserted into a vein in one or both arm(s) and positioned in the PET/MRI. Participants will be injected with [18F]FET and imaged for up to 40 minutes during which time they will receive an injection of gadolinium MR contrast agent.
Participants will be monitored during the imaging to make sure they are not experiencing any side effects and those taking lorazepam will be monitored for confusion or disorientation.
When participants have completed the PET/MRI imaging, the catheters will be removed, and they may resume normal activities.
Participants will receive a follow-up phone call within 48 hours of their imaging visit. Participants will be asked about any changes in their health and side effects that might be due to the investigational drug.
If the PET/MRI is unexpectedly unavailable during any of the imaging visits, participants may undergo brain PET imaging on a scanner located in an adjacent room to the PET/MRI. The radioactive drug administration and PET imaging will be identical to the protocol described above for PET/MRI but participants will not receive MRI contrast.
Clinical follow up
The study team will continue to follow participant's health through their regular clinic visits and imaging as directed under the main study (IRB 300007756).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FET and FMISO PET/MRI studies will be performed on either 1) same day or 2) separate days within 14 days of each other. Baseline imaging will occur within 21 days before surgery. Every effort will be made to perform these studies within 1 week of each other. FMISO-PET/MRI will be administered first with a four-hour uptake time followed by a dynamic FET-PET/MRI (\<90 min total scan time). For separate scans, FET-PET/MRI will typically be performed first although the order can be switched if needed due to PET tracer production or scanner scheduling. Patients will fast for at least 4 hours prior to FET administration and will undergo dynamic scans. No fasting or other special preparation is required for FMISO studies and imaging will be acquired after a four-hour uptake time. Additional post-surgical FET-PET/MRI scans at 1, 3 and 6 months post will follow the same steps as the separately acquired scans except no additional FMISO-PET/MRI will be performed.
Drug: [18F]FMISO-PET with contrast-enhanced MRI
Glioma patients enrolled in the main study (IRB 300007756) will complete 4 to 5 imaging visits. Visit 1 will take place prior to participants scheduled surgery. Visit 1 could be two seperate imaging visits between \[18F\]FMISO and \[18F\]FET, if needed. Participants will have three additional \[18F\]FET PET/MRIs at 1 month, 3 months and 6 months post-surgery.
The frequency of changes in catheter placement based on standard pre-surgical study-specific MRI versus standard MRI combined with results from FET/FMISO PET/MRI
Incidence and frequency that catheter placement changes following the addition of FET/FMISO PET/MRI.
Time frame: Up to 24 weeks
The percent change in imaging metrics associated with FET-PET/MRI (PET (SUV) and MRI metrics (ADC, Ktrans)) from subsequent imaging visits to the baseline.
The incidence and percent change of PET (SUV) and MRI metrics (ADC, Ktrans) from subsequent imaging visits to the baseline.
Time frame: Up to 24 weeks
The variance of mathematical modeling predicted tumor volume to imaging-derived tumor volume (Standard-of-care; FET PET/MRI).
The incidence and variance of predicted tumor volume and imaging-derived tumor volume.
Time frame: Up to 24 weeks
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Nov 2030, 48 months later.
Of 166 non-industry phase 1 interventional studies under Glioma, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 87. This study's planned 48 months is below that.
Counting every sponsor, half of 213 studies reached it within 59 months; a quarter within 36 and three quarters within 88.
Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Nov 2026, on Oct 30, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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University of Alabama at Birmingham →