Grade III or Grade IV GliomaPhase 3DRARCHNCT05479136
18F-Fluciclovine PET Imaging for Detecting High Grade Glioma Recurrence After Radiochemotherapy
A Phase 3 study testing PET imaging with 18F fluciclovine in people with Grade III or Grade IV Glioma, run by Nicole Hill at 1 site in United States.
Trial summary
This study will examine whether positron emission tomography (PET) imaging with fluciclovine can reliably differentiate true progression from pseudoprogression months earlier than the conventional MRI methods. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Grade III or Grade IV Glioma
- What is being tested?
- PET imaging with 18F fluciclovine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2022to 31 Dec 2023
- Phase
- Phase 3
- 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
- Greater than 18 years of age
- Histological diagnosis of primary WHO grade III or IV glioma
- Completed standard radiotherapy
- Undergoing or completed standard chemotherapy (or other therapies)
- Enlarging or new contrast-enhancing mass suspicious for progression/recurrence (at least 10mm in one direction)
- Subjects must agree to take adequate pregnancy preventions from the time of consent until 24 hrs after the 18F-fluciclovine injection.
- Willing and able to provide written informed consent in compliance with the regulatory requirements. If a subject is unable to provide written informed consent, written informed consent may be obtained from the subject's legal representative
Who cannot join
- Simultaneous participation in other interventional trials which could interfere with this trial.
- Inability to undergo a MRI or PET scan (claustrophobia, non-MRI compatible pacemaker, renal insufficiency, known allergy to MRI contrast agent or fluciclovine tracer)
- Subjects who are pregnant or lactating or who suspect they might be pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Barrow Neurological Institute at St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
Poonam Choudhary, 602-406-7810, Poonam.Choudhary@barrowneuro.org
About this study
This study will examine whether positron emission tomography (PET) imaging with fluciclovine can reliably differentiate true progression from pseudoprogression months earlier than the conventional MRI methods.
Read the detailed description
Approximately 40-50% of all glioblastoma patients undergoing standard of care radiochemotherapy will show signs of early disease progression that includes increases in the apparent tumor size on conventional magnetic resonance imaging (MRI) scans. Unfortunately, treatment related effects, including alterations to the blood brain barrier (BBB), can mimic tumor progression on conventional MRI scans, which confounds assessment of tumor progression during and in the months following radiochemotherapy.
An imaging method that provides a reliable early assessment of brain tumor progression could enable patients to enroll into clinical trials months earlier (when tumors are more treatable) and potentially save patients from the adverse side effects of an ineffective radiochemotherapy regimen. Fluciclovine positron emission tomography (PET) imaging has the potential to overcome the limitations of conventional MRI and provide an earlier, more comprehensive assessment of brain tumor progression. Fluciclovine is a radiolabeled amino acid analogue whose transport across the BBB and retention in tumor cells is dictated primarily by upregulated amino acid transporters. Prior studies have shown that amino acid PET with radiotracers similar to fluciclovine can accurately distinguish tumor progression from treatment effects in glioma patients, but these other amino acid radiotracers are not widely available. Another advantage of fluciclovine PET is that is can detect infiltrative tumor cells that are often not discernable on standard conventional MRI and are often in regions beyond that those with disrupted BBB. There are no published studies evaluating whether fluciclovine PET can differentiate progression from treatment effects despite fluciclovine being commercially available and widely accessible. The goals of this proposal are to establish whether fluciclovine PET can: i) identify early progression at time points soon after completion of radiation therapy and ii) differentiate treatment-related effects from true disease progression in patients with suspected recurrent disease.
- Conditions
- Grade III or Grade IV Glioma
- Being tested
- PET imaging with 18F fluciclovine
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET imaging with 18F fluciclovineDrug
Also called Axumin
PET with 18F fluciclovine injection, 185 MBq (5 mCi) ± 20%, delivered as an intravenous bolus
| Study group | Role | What they receive |
|---|---|---|
| PET study | Experimental | Single intravenous administration of 18F fluciclovine for PET Scan Receives: Drug: PET imaging with 18F fluciclovine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain tumor progression
whether fluciclovine PET, a commercially available tracer, provides A reliable measure of brain tumor progression months earlier than conventional MRI.
Measured: 20 weeks
Secondary outcomes (1)
PET uptake and dynamic susceptibility contrast (DSC) perfusion
Establish the spatial correlation between PET uptake and dynamic susceptibility contrast (DSC) perfusion MRI measurements of relative cerebral blood volume (rCBV).
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start24 Aug 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Grade III or Grade IV 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
- Phase 3
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Up to 30 eligible patients will be recruited from out-patient clinic visits at Barrow Neurological Institute.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nicole Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Earth Diagnostics, Barrow Neurological Foundation
- Responsible party
- Sponsor-investigator, Nicole Hill, St. Joseph's Hospital and Medical Center, Phoenix
- Investigators
- Poonam Choudhary, PhD, Principal investigator, Barrow Neurological Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479136
- Sponsor's protocol ID
- PHX-22-500-229-30-08
- Other IDs
- BED-IIT-420
- Acronym
- DRARCH
- Status last verified
- Oct 2022
- First submitted
- 24 Jun 2022
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F-Fluciclovine PET Imaging for Detecting High Grade Glioma Recurrence After Radiochemotherapy
- ClinicalTrials.gov ID
- NCT05479136
- Acronym / sponsor ID
- DRARCH / PHX-22-500-229-30-08
- Conditions
- Grade III or Grade IV Glioma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nicole HillUniversity, hospital or other
- Collaborators
- Blue Earth Diagnostics, Barrow Neurological Foundation
- Study start
- 24 Aug 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 29 Jul 2022 (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 study will examine whether positron emission tomography (PET) imaging with fluciclovine can reliably differentiate true progression from pseudoprogression months earlier than the conventional MRI methods.
Detailed description
Approximately 40-50% of all glioblastoma patients undergoing standard of care radiochemotherapy will show signs of early disease progression that includes increases in the apparent tumor size on conventional magnetic resonance imaging (MRI) scans. Unfortunately, treatment related effects, including alterations to the blood brain barrier (BBB), can mimic tumor progression on conventional MRI scans, which confounds assessment of tumor progression during and in the months following radiochemotherapy.
An imaging method that provides a reliable early assessment of brain tumor progression could enable patients to enroll into clinical trials months earlier (when tumors are more treatable) and potentially save patients from the adverse side effects of an ineffective radiochemotherapy regimen. Fluciclovine positron emission tomography (PET) imaging has the potential to overcome the limitations of conventional MRI and provide an earlier, more comprehensive assessment of brain tumor progression. Fluciclovine is a radiolabeled amino acid analogue whose transport across the BBB and retention in tumor cells is dictated primarily by upregulated amino acid transporters. Prior studies have shown that amino acid PET with radiotracers similar to fluciclovine can accurately distinguish tumor progression from treatment effects in glioma patients, but these other amino acid radiotracers are not widely available. Another advantage of fluciclovine PET is that is can detect infiltrative tumor cells that are often not discernable on standard conventional MRI and are often in regions beyond that those with disrupted BBB. There are no published studies evaluating whether fluciclovine PET can differentiate progression from treatment effects despite fluciclovine being commercially available and widely accessible. The goals of this proposal are to establish whether fluciclovine PET can: i) identify early progression at time points soon after completion of radiation therapy and ii) differentiate treatment-related effects from true disease progression in patients with suspected recurrent disease.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Up to 30 eligible patients will be recruited from out-patient clinic visits at Barrow Neurological Institute.
| Arm | Type | Receives |
|---|---|---|
| PET study | Experimental | Drug: PET imaging with 18F fluciclovineSingle intravenous administration of 18F fluciclovine for PET Scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Greater than 18 years of age
- Histological diagnosis of primary WHO grade III or IV glioma
- Completed standard radiotherapy
- Undergoing or completed standard chemotherapy (or other therapies)
- Enlarging or new contrast-enhancing mass suspicious for progression/recurrence (at least 10mm in one direction)
Key exclusion criteria (3 listed)
- Simultaneous participation in other interventional trials which could interfere with this trial.
- Inability to undergo a MRI or PET scan (claustrophobia, non-MRI compatible pacemaker, renal insufficiency, known allergy to MRI contrast agent or fluciclovine tracer)
- Subjects who are pregnant or lactating or who suspect they might be pregnant.
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 |
|---|---|---|
| PET imaging with 18F fluciclovineAlso: AxuminPET with 18F fluciclovine injection, 185 MBq (5 mCi) ± 20%, delivered as an intravenous bolus | Drug | PET study |
Primary outcome
Brain tumor progression
Time frame: 20 weeks
whether fluciclovine PET, a commercially available tracer, provides A reliable measure of brain tumor progression months earlier than conventional MRI.
1 secondary outcome
PET uptake and dynamic susceptibility contrast (DSC) perfusion
Time frame: 20 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- 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.
Poonam Choudhary, PhD principal investigator
Barrow Neurological Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PET imaging with 18F fluciclovine in people with Grade III or Grade IV Glioma, run by Nicole Hill 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 3 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: status not confirmed, as of the sponsor's last update on 27 Oct 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Poonam Choudhary, PhD (602-406-7810, Poonam.Choudhary@barrowneuro.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain tumor progression (time frame: 20 weeks). 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 27 Oct 2022.