GliomaEarly Phase 1FACBCNCT04114370
Evaluation of 18F-fluciclovine (FACBC) PET/MR Uptake in Participants With Glioma
A Early Phase 1 study testing 18F-fluciclovine in people with Glioma, run by James Mountz at 1 site in United States.
Trial summary
This is a pilot study to assess the ability of [F-18]fluciclovine to differentiate pseudoprogression from progression in participants after therapy, at imaging time points within the 12 week interval post chemoradiation. [F-18]fluciclovine. 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-fluciclovine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2019to 30 Sep 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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
- 1. Age ≥ 18 years old.
- 2. Been previously diagnosed by resection or biopsy with grade 3 or 4 glioma.
- 3. Agree to use adequate contraception as indicated in this protocol.
- 4. Consent to PET scanning and receipt of one injection of 18F-fluciclovine.
- 5. Able to comply with study procedures.
- 6. Able to give written consent.
- 7. Subject has had a standard of care, diagnostic MRI study which was indeterminate due to the inability to differentiate pseudoprogression versus tumor progression.
Who cannot join
- 1. Are a pregnant or breastfeeding female.
- 2. Are participating in a clinical trial of another unlicensed product.
- 3. Are undergoing 18F-fluciclovine PET for reason(s) other than newly diagnosed or recurrent glioma.
- 4. Have a hypersensitivity to 18F-fluciclovine.
- 5. Have acute renal failure or moderate/severe renal impairment, according to local clinical guidelines.
- 6. Have a non-MRI compatible implantable device or another contraindication for MRI scan.
- 7. Are deemed ineligible to participate for other reasons by an investigator.
Trial locations and contacts
1 site in 1 country.
About this study
This is a pilot study to assess the ability of [F-18]fluciclovine to differentiate pseudoprogression from progression in participants after therapy, at imaging time points within the 12 week interval post chemoradiation. [F-18]fluciclovine. PET will be obtained at the time point in the 12 week interval in which MRI demonstrates increase in enhancing volume with the differential diagnosis of pseudoprogression versus tumor progression. At the same time point (at least 6 hours after [F-18]fluciclovine or up to 3 days) F-18 FDG will also be performed consistent with standard clinical practice. The verification of pseudoprogression versus tumor progression will be determined by the regression of enhancing lesion on subsequent MRI imaging obtained as part of standard care.
Read the detailed description
In this pilot study the investigators propose to image 10 participants who have been previously diagnosed by resection or biopsy with grade 3 or 4 glioma.
All glioma cases undergoing resection at UPMC are evaluated by immunohistochemistry for mutations in p53, nuclear localization of ATRX, and the presence of IDH1R132H mutation as part of standard neuropathologic integrated diagnosis using the WHO 2016 diagnostic criteria. All glioma cases resected at UPMC undergo genetic profiling using next generation sequencing.
MRI imaging will be obtained as part of standard clinical care. The MRI sequences include T1 pre and post contrast, T2 FLAIR, DWI, ADC and perfusion sequences using the imaging algorithm for evaluating treatment response in glioma treatment trials. Radiogenomic analysis will be performed using the MRI imaging sequences obtained as standard clinical care.
- Conditions
- Glioma
- Being tested
- 18F-fluciclovine
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-fluciclovineDrug
Prior to beginning PET imaging, 18F-fluciclovine will be administered as an intravenous bolus injection followed by a 10mL saline flush. 18F-fluciclovine will be injected through a cannula (or indwelling catheter) in an antecubital vein or another vein that will provide access. The administration site will be evaluated pre- and post-administration for any reaction. Documentation of administration to a participant will be recorded or as part of the scan upload, including date, prescription number, dose activity (as measured at time of administration), total volume, and start/stop time of administration.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Glioma | Experimental | [F18]fluciclovine will be utilized to assess tumor viability compared with F-18 FDG PET or diagnostic MRI. Receives: Drug: 18F-fluciclovine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the ability of [F-18]fluciclovine to differentiate radionecrosis (pseudoprogression) from tumor recurrence (progression) in patients after therapy, at imaging time points within the 12 week interval post chemoradiation.
To assess the ability of [F-18]fluciclovine to differentiate pseudoprogression from progression as compared to F-18 FDG, regions of interest will be drawn around MRI anatomically defined enhancing tumor regions and translated to both the F-18 FDG and F-18 fluciclovine PET scans to obtain SUV for each tracer. The SUV values will be correlated with the diagnosis of pseudoprogression versus tumor progression as determined by the regression of lesion enhancement on subsequent standard clinical follow up MRI imaging, as described in the protocol.
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start22 Oct 2019
- Primary completion18 May 2021
- Study completion30 Sep 2021
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 GliomaStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- James Mountz
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Earth Diagnostics
- Responsible party
- Sponsor-investigator, James Mountz, University of Pittsburgh
- Investigators
- James M Mountz, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114370
- Sponsor's protocol ID
- STUDY19010216
- Acronym
- FACBC
- Status last verified
- Dec 2022
- First submitted
- 13 Sep 2019
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kotecha R, Aboian M, Nabavizadeh SA, Parent EE, Trifiletti DM, Chao ST. Letter regarding "Contribution of PET imaging to radiotherapy planning and monitoring in glioma patients-a report of the PET/RANO group": 18F-fluciclovine and target volume delineation. Neuro Oncol. 2021 Aug 2;23(8):1408-1409. doi: 10.1093/neuonc/noab097. No abstract available.
PubMed 34081125
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of 18F-fluciclovine (FACBC) PET/MR Uptake in Participants With Glioma
- ClinicalTrials.gov ID
- NCT04114370
- Acronym / sponsor ID
- FACBC / STUDY19010216
- Conditions
- Glioma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- James MountzUniversity, hospital or other
- Collaborators
- Blue Earth Diagnostics
- Study start
- 22 Oct 2019 (actual)
- Primary completion
- 18 May 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 3 Oct 2019 (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 is a pilot study to assess the ability of [F-18]fluciclovine to differentiate pseudoprogression from progression in participants after therapy, at imaging time points within the 12 week interval post chemoradiation. [F-18]fluciclovine. PET will be obtained at the time point in the 12 week interval in which MRI demonstrates increase in enhancing volume with the differential diagnosis of pseudoprogression versus tumor progression. At the same time point (at least 6 hours after [F-18]fluciclovine or up to 3 days) F-18 FDG will also be performed consistent with standard clinical practice. The verification of pseudoprogression versus tumor progression will be determined by the regression of enhancing lesion on subsequent MRI imaging obtained as part of standard care.
Detailed description
In this pilot study the investigators propose to image 10 participants who have been previously diagnosed by resection or biopsy with grade 3 or 4 glioma.
All glioma cases undergoing resection at UPMC are evaluated by immunohistochemistry for mutations in p53, nuclear localization of ATRX, and the presence of IDH1R132H mutation as part of standard neuropathologic integrated diagnosis using the WHO 2016 diagnostic criteria. All glioma cases resected at UPMC undergo genetic profiling using next generation sequencing.
MRI imaging will be obtained as part of standard clinical care. The MRI sequences include T1 pre and post contrast, T2 FLAIR, DWI, ADC and perfusion sequences using the imaging algorithm for evaluating treatment response in glioma treatment trials. Radiogenomic analysis will be performed using the MRI imaging sequences obtained as standard clinical care.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Glioma | Experimental | Drug: 18F-fluciclovine[F18]fluciclovine will be utilized to assess tumor viability compared with F-18 FDG PET or diagnostic MRI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1. Age ≥ 18 years old.
- 2. Been previously diagnosed by resection or biopsy with grade 3 or 4 glioma.
- 3. Agree to use adequate contraception as indicated in this protocol.
- 4. Consent to PET scanning and receipt of one injection of 18F-fluciclovine.
- 5. Able to comply with study procedures.
Key exclusion criteria (7 listed)
- 1. Are a pregnant or breastfeeding female.
- 2. Are participating in a clinical trial of another unlicensed product.
- 3. Are undergoing 18F-fluciclovine PET for reason(s) other than newly diagnosed or recurrent glioma.
- 4. Have a hypersensitivity to 18F-fluciclovine.
- 5. Have acute renal failure or moderate/severe renal impairment, according to local clinical guidelines.
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-fluciclovinePrior to beginning PET imaging, 18F-fluciclovine will be administered as an intravenous bolus injection followed by a 10mL saline flush. 18F-fluciclovine will be injected through a cannula (or indwelling catheter) in an antecubital vein or another vein that will provide access. The administration site will be evaluated pre- and post-administration for any reaction. Documentation of administration to a participant will be recorded or as part of the scan upload, including date, prescription number, dose activity (as measured at time of administration), total volume, and start/stop time of administration. | Drug | Participants with Glioma |
Primary outcome
To assess the ability of [F-18]fluciclovine to differentiate radionecrosis (pseudoprogression) from tumor recurrence (progression) in patients after therapy, at imaging time points within the 12 week interval post chemoradiation.
Time frame: 90 minutes
To assess the ability of [F-18]fluciclovine to differentiate pseudoprogression from progression as compared to F-18 FDG, regions of interest will be drawn around MRI anatomically defined enhancing tumor regions and translated to both the F-18 FDG and F-18 fluciclovine PET scans to obtain SUV for each tracer. The SUV values will be correlated with the diagnosis of pseudoprogression versus tumor progression as determined by the regression of lesion enhancement on subsequent standard clinical follow up MRI imaging, as described in the protocol.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- Derived from this study: PubMed 34081125Kotecha R, Aboian M, Nabavizadeh SA, Parent EE, Trifiletti DM, Chao ST. Letter regarding "Contribution of PET imaging to radiotherapy planning and monitoring in glioma patients-a report of the PET/RANO group": 18F-fluciclovine and target volume delineation. Neuro Oncol. 2021 Aug 2;23(8):1408-1409. doi: 10.1093/neuonc/noab097. No abstract available.
- 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. This study is not recruiting at the moment.
James M Mountz, MD principal investigator
University of Pittsburgh
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-fluciclovine in people with Glioma, run by James Mountz 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 7 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: finished, as of the sponsor's last update on 6 Dec 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the ability of [F-18]fluciclovine to differentiate radionecrosis (pseudoprogression) from tumor recurrence (progression) in patients after therapy, at imaging time points within the 12 week interval post chemoradiation. (time frame: 90 minutes). 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 NCT04114370, 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 6 Dec 2022.