GliomaEarly Phase 1NCT07778979
Multiparametric Metabolic and Hypoxic PET/MRI Imaging Substudy in Gliomas
A Early Phase 1 study testing [18F]FMISO-PET with contrast-enhanced MRI in people with Glioma, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma
- What is being tested?
- [18F]FMISO-PET with contrast-enhanced MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Nov 2030
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants from IRB 300007756
- 18 years of age or older at the time of enrollment
- Able to undergo PET/MRI without anesthesia or sedation. Minimal sedation with ananxiolytic such as alprazolam used routinely for SOC MRI is allowed.
- Females with childbearing potential must have a negative urine β-hCG test on the day of procedure or a serum hCG test within 48 hours prior to the administration of FET or FMISO.
- ECOG performance score of 2 or better
- Life expectancy greater than 12 weeks.
Who cannot join
- Any exclusions listed in IRB 300007756
- Pregnancy or breast feeding
- Inability to complete PET/MRI scans.
- Significant renal dysfunction (estimated GFR < 30 mL/min)
- Any condition which may interfere with ability to participate in or complete all study-related activities as assessed by the study team
- Unable to undergo MRI
- Contraindication to gadolinium-based contrast
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UAB
Birmingham, Alabama, 35249
Sebastian Eady, 205-996-2636, smeady@uabmc.edu
Ashley Barnes, alstrickland@uabmc.edu
About this study
Official title: Multiparametric Metabolic and Hypoxic PET/MRI Imaging Substudy for Disease Assessment and Guidance of Catheters in Patients With Recurrent/Progressive Malignant Gliomas Eligible for Catheter-delivered Therapies
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.
Read the detailed description
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.
- DAY - Baseline Separate FMISO-PET/MRI and FET-PET/MRI Imaging Visits
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).
- Conditions
- Glioma
- Being tested
- [18F]FMISO-PET with contrast-enhanced MRI
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]FMISO-PET with contrast-enhanced MRIDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Glioma patients enrolled in main study [18F]FMISO and [18F]FET PET/MRI | Experimental | 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. Receives: Drug: [18F]FMISO-PET with contrast-enhanced MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 24 weeks
Secondary outcomes (1)
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.
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2030 (estimated)
- Study completionNov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Anna G. Sorace, University of Alabama at Birmingham
- Investigators
- Anna Sorace, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07778979
- Sponsor's protocol ID
- IRB-300017146
- Other IDs
- 1R01CA313500
- Status last verified
- Oct 2026
- First submitted
- 18 Aug 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiparametric Metabolic and Hypoxic PET/MRI Imaging Substudy for Disease Assessment and Guidance of Catheters in Patients With Recurrent/Progressive Malignant Gliomas Eligible for Catheter-delivered Therapies
- ClinicalTrials.gov ID
- NCT07778979
- Acronym / sponsor ID
- IRB-300017146
- Conditions
- Glioma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2030 (estimated)
- Study completion
- Nov 2030 (estimated)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
- DAY - Baseline Separate FMISO-PET/MRI and FET-PET/MRI Imaging Visits
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glioma patients enrolled in main study [18F]FMISO and [18F]FET PET/MRI | Experimental | Drug: [18F]FMISO-PET with contrast-enhanced MRIFET 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants from IRB 300007756
- 18 years of age or older at the time of enrollment
- Able to undergo PET/MRI without anesthesia or sedation. Minimal sedation with ananxiolytic such as alprazolam used routinely for SOC MRI is allowed.
- Females with childbearing potential must have a negative urine β-hCG test on the day of procedure or a serum hCG test within 48 hours prior to the administration of FET or FMISO.
- ECOG performance score of 2 or better
Key exclusion criteria (7 listed)
- Any exclusions listed in IRB 300007756
- Pregnancy or breast feeding
- Inability to complete PET/MRI scans.
- Significant renal dysfunction (estimated GFR < 30 mL/min)
- Any condition which may interfere with ability to participate in or complete all study-related activities as assessed by the study team
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]FMISO-PET with contrast-enhanced MRIGlioma 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. | Drug | Glioma patients enrolled in main study [18F]FMISO and [18F]FET PET/MRI |
Primary outcome
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
Time frame: Up to 24 weeks
Incidence and frequency that catheter placement changes following the addition of FET/FMISO PET/MRI.
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.
Time frame: Up to 24 weeks
The incidence and percent change of PET (SUV) and MRI metrics (ADC, Ktrans) from subsequent imaging visits to the baseline.
1 secondary outcome
The variance of mathematical modeling predicted tumor volume to imaging-derived tumor volume (Standard-of-care; FET PET/MRI).
Time frame: Up to 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna Sorace, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing [18F]FMISO-PET with contrast-enhanced MRI in people with Glioma, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sebastian Eady (205-996-2636, smeady@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Up to 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.