GlioblastomaEarly Phase 1GBMNCT06613841
Multitracer [18F]Fluciclovine and 18F-FDG PET, and Advanced MRI for Metabolic Profiling of Glioblastoma
A Early Phase 1 study testing Fluciclovine F18 in people with Glioblastoma and Recurrent Glioblastoma, run by Abramson Cancer Center at Penn Medicine at 2 sites in United States.
Trial summary
To perform metabolic phenotyping of treatment naïve and recurrent GBM by multitracer [18F]Fluciclovine and 18F-FDG PET. To compare uptake measures of 18F-Fluciclovine and 18F-FDG and MRI quantification of glutamate and lactate levels to tumor tissue laboratory assays (RNA seq and proteomics) of glutamine/glutamate… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Recurrent Glioblastoma, Glioblastoma Multiforme of Brain
- What is being tested?
- Fluciclovine F18
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 May 2025to 31 Dec 2027
- 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 will be ≥ 18 years of age
- Must meet the following criteria:
- -Diagnosis of a new intra-axial brain mass that is consistent with GBM per the opinion of a Penn neuroradiologist.
- OR
- New contrast-enhancing lesion or lesions showing increased enhancement (\>25%increase) in a patient with a historical diagnosis of glioblastoma (histologic or molecular proof) on standard MRI after completion of treatment
- Recommended for clinically indicated surgical resection
Show all 9Show fewer
- Life expectancy of greater than 3 months in the opinion of an investigator or treating physician.
- Karnofsky performance status ≥ 60 per medical record review
- Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.
Who cannot join
- Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
- Females who are pregnant or breastfeeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of childbearing potential prior to injection.
- Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study
- Contraindications to MRI
- Only individuals (aged 18 or over) who can understand and give informed consent will be approached to participate in this study
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Jeremy T Westerman, B.S. Biology, 2159199110, Jeremy.Westerman@pennmedicine.upenn.edu
Leeanne Lezotte, 8563643137, leeanne.lezotte@pennmedicine.upenn.edu
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Leeanne Lezotte, 8563643137, leeanne.lezotte@pennmedicine.upenn.edu
Jeremy T Westerman, B.S., 2159199110, jeremy.westerman@pennmedicine.upenn.edu
About this study
Official title: Pilot Study to Evaluate Multitracer [18F]Fluciclovine and 18F-FDG PET, and Advanced MRI Methods at 7Tesla Metabolic Profiling of Glioblastoma
- To perform metabolic phenotyping of treatment naïve and recurrent GBM by multitracer [18F]Fluciclovine and 18F-FDG PET.
- To compare uptake measures of 18F-Fluciclovine and 18F-FDG and MRI quantification of glutamate and lactate levels to tumor tissue laboratory assays (RNA seq and proteomics) of glutamine/glutamate, glucose, and lactate metabolism.
- To perform metabolic phenotyping of treatment naïve and recurrent GBM by advanced MRI methods at 7 Tesla
Read the detailed description
Subjects with a new intra-axial brain mass that is consistent with glioblastoma (GBM) on brain MRI or post-treatment histologically or molecularly proven GBM who are suspected to have progression and are candidates for surgical resection according to standard of care may be eligible for this study.
Subjects will undergo approximately 45 minutes of dynamic PET/CT scanning after injection of 2 mCi (±20%) of 18F-Fluciclovine. The subject will have a 60-minute break after this initial scan session, they will be allowed to get off the scanner during this time and encouraged to stay hydrated and void as necessary. To confirm that the blood sugar is not high, a glucose test will be performed before the next scan. Subsequently, the subjects will undergo injection of up to 10 mCi of 18F-FDG followed by a static 20-minute scan approximately 60 minutes post injection Subjects will have the option to undergo PET/CT imaging with 18F-Fluciclovine and 18F-FDG on separate days as long as the imaging happens within 7 business days. An optional 60-minute brain MRI without contrast will also be performed with the 7.0 Tesla MRI machine. The timing of the optional second PET scans will be within 7 business days of the baseline PET scans.
Positron emission tomography (PET/CT) imaging will be used to evaluate 18F-fluciclovine and 18F-FDG uptake in treatment naïve and recurrent GBM. Brain MR with Chemical Exchange Saturation Transfer (CEST) and MR spectroscopy (MRS) will be used to determine the glutamate and lactate levels. In addition, clinical brain MRI with and without contrast will be used to evaluate the tumor pre-operatively. This is a non-therapeutic trial in that imaging will not be used to direct treatment decisions.
- Being tested
- Fluciclovine F18
- Keywords
- Early Phase 1, Cohort, Glioblastoma
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluciclovine F18Drug
To perform metabolic phenotyping of treatment naïve and recurrent GBM by multitracer [18F]Fluciclovine and 18F-FDG PET.
| Study group | Role | What they receive |
|---|---|---|
| Imaging Cohort | Experimental | Up to 15 subjects will enroll in this imaging study at the University of Pennsylvania. Those with a diagnosis of a new intra-axial brain mass that is consistent with GBM per the opinion of a Penn neuroradiologist OR New contrast-enhancing lesion or lesions showing increased enhancement (>25% increase) in a patient with a historical diagnosis of glioblastoma. Receives: Drug: Fluciclovine F18 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake Values (SUV)
Quantification of [18F]Fluciclovine and 18F-FDG uptake values (SUV) in treatment naïve and recurrent GBM.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start1 May 2025
- Primary completion1 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Nabavizadeh, University of Pennsylvania
- Investigators
- Ali Nabavizadeh, MD, Principal investigator, University of Pensylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06613841
- Sponsor's protocol ID
- UPCC15324
- Acronym
- GBM
- Status last verified
- Sep 2026
- First submitted
- 28 Aug 2024
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nabavizadeh A, Bagley SJ, Doot RK, Ware JB, Young AJ, Ghodasara S, Zhao C, Anderson H, Schubert E, Carpenter EL, Till J, Henderson F Jr, Pantel AR, Chen HI, Lee JYK, Amankulor NM, O'Rourke DM, Desai A, Nasrallah MP, Brem S. Distinguishing Progression from Pseudoprogression in Glioblastoma Using 18F-Fluciclovine PET. J Nucl Med. 2023 Jun;64(6):852-858. doi: 10.2967/jnumed.122.264812. Epub 2022 Dec 22.
PubMed 36549916
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate Multitracer [18F]Fluciclovine and 18F-FDG PET, and Advanced MRI Methods at 7Tesla Metabolic Profiling of Glioblastoma
- ClinicalTrials.gov ID
- NCT06613841
- Acronym / sponsor ID
- GBM / UPCC15324
- Keywords
- Early Phase 1, Cohort, Glioblastoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Sep 2024 (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.
- To perform metabolic phenotyping of treatment naïve and recurrent GBM by multitracer [18F]Fluciclovine and 18F-FDG PET.
- To compare uptake measures of 18F-Fluciclovine and 18F-FDG and MRI quantification of glutamate and lactate levels to tumor tissue laboratory assays (RNA seq and proteomics) of glutamine/glutamate, glucose, and lactate metabolism.
- To perform metabolic phenotyping of treatment naïve and recurrent GBM by advanced MRI methods at 7 Tesla
Detailed description
Subjects with a new intra-axial brain mass that is consistent with glioblastoma (GBM) on brain MRI or post-treatment histologically or molecularly proven GBM who are suspected to have progression and are candidates for surgical resection according to standard of care may be eligible for this study.
Subjects will undergo approximately 45 minutes of dynamic PET/CT scanning after injection of 2 mCi (±20%) of 18F-Fluciclovine. The subject will have a 60-minute break after this initial scan session, they will be allowed to get off the scanner during this time and encouraged to stay hydrated and void as necessary. To confirm that the blood sugar is not high, a glucose test will be performed before the next scan. Subsequently, the subjects will undergo injection of up to 10 mCi of 18F-FDG followed by a static 20-minute scan approximately 60 minutes post injection Subjects will have the option to undergo PET/CT imaging with 18F-Fluciclovine and 18F-FDG on separate days as long as the imaging happens within 7 business days. An optional 60-minute brain MRI without contrast will also be performed with the 7.0 Tesla MRI machine. The timing of the optional second PET scans will be within 7 business days of the baseline PET scans.
Positron emission tomography (PET/CT) imaging will be used to evaluate 18F-fluciclovine and 18F-FDG uptake in treatment naïve and recurrent GBM. Brain MR with Chemical Exchange Saturation Transfer (CEST) and MR spectroscopy (MRS) will be used to determine the glutamate and lactate levels. In addition, clinical brain MRI with and without contrast will be used to evaluate the tumor pre-operatively. This is a non-therapeutic trial in that imaging will not be used to direct treatment decisions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imaging Cohort | Experimental | Drug: Fluciclovine F18Up to 15 subjects will enroll in this imaging study at the University of Pennsylvania. Those with a diagnosis of a new intra-axial brain mass that is consistent with GBM per the opinion of a Penn neuroradiologist OR New contrast-enhancing lesion or lesions showing increased enhancement (>25% increase) in a patient with a historical diagnosis of glioblastoma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participants will be ≥ 18 years of age
- -Diagnosis of a new intra-axial brain mass that is consistent with GBM per the opinion of a Penn neuroradiologist.
- OR
- New contrast-enhancing lesion or lesions showing increased enhancement (\>25%increase) in a patient with a historical diagnosis of glioblastoma (histologic or molecular proof) on standard MRI after completion of treatment
- Recommended for clinically indicated surgical resection
Key exclusion criteria (5 listed)
- Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
- Females who are pregnant or breastfeeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of childbearing potential prior to injection.
- Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study
- Contraindications to MRI
- Only individuals (aged 18 or over) who can understand and give informed consent will be approached to participate in this study
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 |
|---|---|---|
| Fluciclovine F18To perform metabolic phenotyping of treatment naïve and recurrent GBM by multitracer [18F]Fluciclovine and 18F-FDG PET. | Drug | Imaging Cohort |
Primary outcome
Uptake Values (SUV)
Time frame: 2 years
Quantification of [18F]Fluciclovine and 18F-FDG uptake values (SUV) in treatment naïve and recurrent GBM.
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 9 Sep 2026.
- Results publication: PubMed 36549916Nabavizadeh A, Bagley SJ, Doot RK, Ware JB, Young AJ, Ghodasara S, Zhao C, Anderson H, Schubert E, Carpenter EL, Till J, Henderson F Jr, Pantel AR, Chen HI, Lee JYK, Amankulor NM, O'Rourke DM, Desai A, Nasrallah MP, Brem S. Distinguishing Progression from Pseudoprogression in Glioblastoma Using 18F-Fluciclovine PET. J Nucl Med. 2023 Jun;64(6):852-858. doi: 10.2967/jnumed.122.264812. Epub 2022 Dec 22.
- Individual participant dataSharing planned: Undecided
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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.
Ali Nabavizadeh, MD principal investigator
University of Pensylvania
2 sites 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 Fluciclovine F18 in people with Glioblastoma and Recurrent Glioblastoma, run by Abramson Cancer Center at Penn Medicine at 2 sites 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 9 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Leeanne Lezotte (8563643137, leeanne.lezotte@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake Values (SUV) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06613841, which also lists 1 linked publication.
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 9 Sep 2026.