An Early Phase 1 interventional study of Fluciclovine F18 in Glioblastoma, Recurrent Glioblastoma and Glioblastoma Multiforme of Brain, sponsored by Abramson Cancer Center at Penn Medicine. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Abramson Cancer Center at Penn Medicine · Early Phase 1, Interventional, and Diagnostic
Among 11 studies in Glioblastoma by Abramson Cancer Center at Penn Medicine — 3 open to participants now, 4 under way, none of them phase 3. Glioblastoma · Abramson Cancer Center at Penn Medicine.
Among the 11 studies in Glioblastoma by Abramson Cancer Center at Penn Medicine, this one is the 7th largest by planned enrollment of the 10 interventional ones that give a count, is the only one that started in 2025, is one of 6 in phase 1, and was the 10th registered.
2,134 studies on the registry are indexed under Glioblastoma; 466 are open to participants now.
Browse Glioblastoma studies →3 of the 11 studies in Glioblastoma by Abramson Cancer Center at Penn Medicine are open now, in 1 country. Recruiting first, the newest first:
Abramson Cancer Center at Penn Medicine · Sites in United States
Ages 22+
Abramson Cancer Center at Penn Medicine · Sites in United States
Ages 18+
By country, each count listing its studies:
Of the 339 Glioblastoma studies recruiting now, 234 (69%) set no upper age limit and 65 (19%) stop at 75 or younger; 27 take children under 18; 13 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.
11 studies; the count open now beside each. This study's row is marked.
First in 1996; this study’s year is marked. 1 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 15 is below the median of 36 across 1,755 interventional studies indexed under Glioblastoma.
Median enrollment 21 across the 10 interventional studies. Of the 6 that completed or were terminated, 0 (0%) have results posted.
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Abramson Cancer Center at Penn Medicine is the lead sponsor of 461 studies on the registry; 88 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 14 (42%) have results posted.
2 of the studies in Glioblastoma by Abramson Cancer Center at Penn Medicine that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05086497Abramson Cancer Center at Penn MedicineWBSI Guided Personalized Delivery of TTFields | 2027-06-30 |
| NCT06613841Abramson Cancer Center at Penn MedicineMultitracer [18F]Fluciclovine and 18F-FDG PET, and Advanced MRI for Metabolic Profiling of Glioblastoma | 2027-10-01 |
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Among the 11 studies in Glioblastoma by Abramson Cancer Center at Penn Medicine, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
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
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.
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.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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 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.
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.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
Drug: Fluciclovine F18
To perform metabolic phenotyping of treatment naïve and recurrent GBM by multitracer \[18F\]Fluciclovine and 18F-FDG PET.
Uptake Values (SUV)
Quantification of \[18F\]Fluciclovine and 18F-FDG uptake values (SUV) in treatment naïve and recurrent GBM.
Time frame: 2 years
PET uptake values relation to kinetic parameters
Correlation of PET uptake values (SUV) and kinetic parameters (volume of distribution) with gene expression of glutamine and glucose metabolism.
Time frame: 2 years
Quantification of glutamate and lactate levels
The amount of metabolic markers (e.g., glutamate, 5 to 15 mM in normal brain tissue) using 7T MRI. Tumors with high glutamate secretion are associated with increased tumor cell invasiveness.
Time frame: 2 years
Plan to share: Undecided
Started May 2025 (actual). Primary completion is estimated for Oct 2027, 29 months after the start.
Of 240 non-industry phase 1 interventional studies under Glioblastoma, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 76. This study's planned 29 months is below that.
Counting every sponsor, half of 322 studies reached it within 44 months; a quarter within 29 and three quarters within 73.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Fluciclovine F-18
Abramson Cancer Center at Penn Medicine →