Brain TumorPhase 1/2NCT03276676
[18F]Fluciclovine and [18F]FLT PET/CT Assessment of Primary High-Grade Brain Tumors
A Phase 1/2 study testing [18F]FLT and [18F]Fluciclovine in people with Brain Tumor, run by University of Utah at 1 site in United States.
Trial summary
The hypothesis of this exploratory clinical trial in patients with high-grade a primary brain tumor who receive chemoradiation is that the PET imaging agents [18F]Fluciclovine and/or [18F]FLT will be a better predictor of tumor response than standard MRI based brain tumor response criteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor
- What is being tested?
- [18F]FLT and [18F]Fluciclovine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2018to 18 Aug 2023
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Two adult patient groups will be eligible for inclusion in this study:
- Group A: Patients where there is compelling evidence, based on the MRI and/or CT imaging, that a high-grade primary brain tumor is present. Pathologic confirmation will occur with biopsy or surgery.
- Patients whose tumor is felt to be inoperable and a biopsy is performed but no surgery.
- Patients with a newly diagnosed primary malignant brain tumor (WHO Grade III or IV) who will be receiving chemoradiation and who either did not undergo surgical resection or underwent incomplete resection with residual tumor > 1.0 cm in greatest diameter by contrast MRI postoperatively.
- Group B: Patients with pathologically proven malignant brain tumor (WHO Grade III or IV glial-based tumors) who have undergone chemoradiation and have MRI-documented possible recurrence/progression versus treatment effect (pseudoprogression) within 6 months from the time of completion of chemoradiation.
- Patients must be 18 years or older for inclusion in this study. There is little experience with the safety of [18F]FLT or [18F]Fluciclovine in children, and the risks associated with radiation exposure may be increased for children under 18 years old as well.
Show all 10Show fewer
- Patients must document their willingness to be followed for at least 24 months after recruitment by signing informed consent documenting their agreement to have clinical endpoints and the results of histopathologic tissue analysis (when tissue becomes available from routine care) entered into a research database.
- All patients, or their legal guardians, must sign a written informed consent and HIPAA authorization in accordance with institutional guidelines.
- Determination of pregnancy status: Female patients who are not postmenopausal or surgically sterile will undergo a serum pregnancy test prior to each set of [18F]FLT and [18F]Fluciclovine PET scans. A negative test will be necessary for such patients to undergo research PET imaging.
- Pre-imaging laboratory tests must be performed within 28 days prior to the [18F]FLT imaging procedure. These must be less than 4.0 times below or above the upper or lower limit range for the respective laboratory test for entry into the study (unless clinically not relevant). In those instances where a laboratory value is outside of this range, then such a patient will be ineligible for enrollment unless at the discretion of the PI the abnormal lab value is of no clinical significance to the safety or integrity of the study results. . For follow-up scanning sessions after therapy has been instituted, laboratory testing will also be required due to the use of [18F]FLT. The patients have brain tumors and will have received chemoradiation; therefore, many routine laboratory tests may not be within the typical normal range. As such, a factor of 4.0 times above or below the upper or lower value for the normal range for any laboratory test will also be used to determine the acceptable range for the 2nd and possibly 3rd imaging time points (unless clinically not relevant as explained above). The baseline laboratory testing will include liver enzymes (ALT, AST), bilirubin (total), serum electrolytes, CBC with platelets, prothrombin time, partial thromboplastin time, BUN, and creatinine. For those patients receiving coumadin or another anticoagulant the upper limit for prothrombin time or partial thromboplastin time must not exceed 6 times the upper limit of the normal range. (Appendix E, Laboratory Study Results).
Who cannot join
- Patients with clinically significant signs of uncal herniation, such as acute pupillary enlargement, rapidly developing motor changes (over hours), or rapidly decreasing level of consciousness, are not eligible.
- Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals. Patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator's discretion.
- Patients who are pregnant or lactating or who suspect they might be pregnant. Serum pregnancy tests will be obtained prior to each set of multi-tracer PET scans in female patients that are not postmenopausal or surgically sterile.
- Adult patients who require monitored anesthesia for PET scanning.
- Patients who are too claustrophobic to undergo PET scanning.
- Known HIV positive patients due to the previous toxicity noted with [18F]FLT in this patient group.
Trial locations and contacts
1 site in 1 country.
United States1 site
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
About this study
The hypothesis of this exploratory clinical trial in patients with high-grade a primary brain tumor who receive chemoradiation is that the PET imaging agents [18F]Fluciclovine and/or [18F]FLT will be a better predictor of tumor response than standard MRI based brain tumor response criteria. When used in conjunction, the two PET agents may be better able to predict tumor aggressiveness and thus overall survival than the use of individual-tracer PET biomarkers. This may eventually lead to improved assessment of response (including time to progression and overall survival) and differentiation of tumor recurrence/progression from treatment effect (pseudoprogression).
Read the detailed description
The standard treatment approach for patients with high-grade primary brain tumors includes maximum feasible surgical resection, followed by 6 weeks of concurrent cranial irradiation, and daily low-dose temozolomide chemotherapy; followed by 12 cycles of high-dose temozolomide administered for 5 consecutive days every 4 weeks (Stupp et al., 2005). Contrast-enhanced MRI is the current standard for evaluating the success of therapy and monitoring for tumor recurrence. MRI is typically obtained prior to initial surgery, within 24 hours after surgery, at the conclusions of cranial irradiation, and then every 8 weeks during temozolomide chemotherapy until evidence of recurrence. Despite this careful clinical and radiographic surveillance, and despite decades of research into the histologic and molecular classification of primary brain tumors, our ability to predict tumor behavior remains very limited. Some gliomas will result in overall survival times of only months, whereas other histologically-identical gliomas may yield survivals of years to decades (Curran et al., 1993, Carson et al., 2007). Current assessment of tumor response to therapy is also poor. Patients with complete radiographic response after cranial irradiation often progress rapidly post-irradiation. In contrast, some patients with enhancing masses at the end of chemoradiotherapy may respond dramatically to further chemotherapy alone; or the masses may even disappear in the absence of further therapy, so called "tumor pseudoprogression" (Chamberlain et al., 2007). This confounding situation demonstrates a need for better assessment of tumor response.
Improvements in the ability to predict tumor behavior prior to the start of therapy would allow more efficient and effective tumor surveillance; better prognostication; and more appropriate assignment of patients to conventional, aggressive, or investigational therapies early in their clinical courses. This would provide huge economic and social benefits, and could afford decisive insights into brain tumor physiology and biology.
Similarly, the ability to identify, earlier and more accurately, whether individual patients were responding to therapy would allow prompt discontinuation of ineffectual treatments and institution of potentially more effective therapies.
Previous efforts using imaging for such tasks have generally been limited to a single modality (e.g. MRI) and/or single-tracer (e.g. FDG-PET). However, there is a significant and growing body of evidence that complementary imaging of multiple aspects of tumor physiology (i.e. using multiple PET tracers) can provide greatly enhanced information over imaging with a single modality or tracer alone. In solid tumors, complex interactions exist between blood flow, metabolic activity, and oxygen status which affect metastatic and proliferative activity. Heterogeneous tumors may contain both slow-growing and fast-growing regions that present different profiles of proliferation rates and amino acid uptake.
- Conditions
- Brain Tumor
- Being tested
- [18F]FLT, [18F]Fluciclovine
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]FLTDrug
PET exams of [18F]FLT will be acquired in each patient at up to three time points: (1) prior to any tumor-directed therapy, either prior to surgery or immediately after surgery providing a complete surgical resection was not performed and confirmed by a post-operative contrast MRI scan where residual tumor > 1.0 cm in diameter was present and prior to any tumor-directed therapy; (2) at the conclusions of the initial (~6-8 weeks) chemoradiotherapy; and (3) patients with MRI-documented possible recurrence/progression versus treatment effect (pseudoprogression) within 6 months from the time of completion of chemoradiation.
[18F]FluciclovineDrug
PET exams of [18F]Fluciclovine will be acquired in each patient at up to three time points: (1) prior to any tumor-directed therapy, either prior to surgery or immediately after surgery providing a complete surgical resection was not performed and confirmed by a post-operative contrast MRI scan where residual tumor > 1.0 cm in diameter was present and prior to any tumor-directed therapy; (2) at the conclusions of the initial (~6-8 weeks) chemoradiotherapy; and (3) patients with MRI-documented possible recurrence/progression versus treatment effect (pseudoprogression) within 6 months from the time of completion of chemoradiation.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Participants enrolled in Group A will undergo a maximum of 6 scans throughout this study. [18F]FLT- and [18F]Fluciclovine-PET/CT scans at up to three imaging time points: (1) prior to any tumor-directed therapy, (2) within 1-4 weeks after the conclusion of the intitial (~6-8 weeks) chemoradiotherapy, and (3) following suspected recurrence/progression versus treatment effect (pseudoprogression) shown with MRI, within 6 months of the completion of chemoradiation Receives: Drug: [18F]FLT; Drug: [18F]Fluciclovine |
| Group B | Experimental | Participants enrolled in Group B will undergo 2 scans as part of this study. [18F]FLT- and [18F]Fluciclovine-PET/CT scans will be acquired at a single timepoint, at the time of suspected pseudoprogression. Receives: Drug: [18F]FLT; Drug: [18F]Fluciclovine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Count of Patients Showing >25% Reduction in Cerebral Uptake of [18F]FLT and [18F]Fluciclovine
Cerebral uptake of [18F]FLT and [18F]Fluciclovine measured in terms of SUVmax and SUVmean at each imaging time point ((1) prior to any tumor-directed therapy, (2) within 1-4 weeks after the conclusion of the initial (~6-8 weeks) chemoradiotherapy, and (3) following suspected recurrence/progression versus treatment effect (pseudoprogression) shown with MRI, within 6 months of the completion of chemoradiation). Using the first time point as baseline for the following two time points, the percent change is calculated from SUVmean and SUVmax for each of the radiotracers studied in this trial.
This measure only applies to Group A, as multiple time points of scan data are needed to calculate change in uptake.
Measured: (1) Baseline [18F]FLT and [18F]Fluciclovine scans were acquired prior to initiating therapy, follow-up scans were acquired (2) 1-4 weeks following conclusion of initial chemoradiation, and (3) within 6 months of completion of chemoradiation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start24 Sep 2018
- Primary completion12 Apr 2021
- Study completion18 Aug 2023
Why it stopped: poor accrual and PI retired
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Both arms will undergo the same interventions, however, Group A will undergo three imaging sessions and Group B will undergo one imaging session
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Earth Diagnostics
- Responsible party
- Sponsor
- Investigators
- Jeffrey Yap, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03276676
- Sponsor's protocol ID
- HCI104704
- Status last verified
- Oct 2024
- First submitted
- 5 Sep 2017
- Last updated
- 27 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [18F]Fluciclovine and [18F]FLT PET/CT Assessment of Primary High-Grade Brain Tumors
- ClinicalTrials.gov ID
- NCT03276676
- Acronym / sponsor ID
- HCI104704
- Conditions
- Brain Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor accrual and PI retired
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Blue Earth Diagnostics
- Study start
- 24 Sep 2018 (actual)
- Primary completion
- 12 Apr 2021 (actual)
- Study completion
- 18 Aug 2023 (actual)
- First posted
- 8 Sep 2017 (actual)
- Results
- Posted 27 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis of this exploratory clinical trial in patients with high-grade a primary brain tumor who receive chemoradiation is that the PET imaging agents [18F]Fluciclovine and/or [18F]FLT will be a better predictor of tumor response than standard MRI based brain tumor response criteria. When used in conjunction, the two PET agents may be better able to predict tumor aggressiveness and thus overall survival than the use of individual-tracer PET biomarkers. This may eventually lead to improved assessment of response (including time to progression and overall survival) and differentiation of tumor recurrence/progression from treatment effect (pseudoprogression).
Detailed description
The standard treatment approach for patients with high-grade primary brain tumors includes maximum feasible surgical resection, followed by 6 weeks of concurrent cranial irradiation, and daily low-dose temozolomide chemotherapy; followed by 12 cycles of high-dose temozolomide administered for 5 consecutive days every 4 weeks (Stupp et al., 2005). Contrast-enhanced MRI is the current standard for evaluating the success of therapy and monitoring for tumor recurrence. MRI is typically obtained prior to initial surgery, within 24 hours after surgery, at the conclusions of cranial irradiation, and then every 8 weeks during temozolomide chemotherapy until evidence of recurrence. Despite this careful clinical and radiographic surveillance, and despite decades of research into the histologic and molecular classification of primary brain tumors, our ability to predict tumor behavior remains very limited. Some gliomas will result in overall survival times of only months, whereas other histologically-identical gliomas may yield survivals of years to decades (Curran et al., 1993, Carson et al., 2007). Current assessment of tumor response to therapy is also poor. Patients with complete radiographic response after cranial irradiation often progress rapidly post-irradiation. In contrast, some patients with enhancing masses at the end of chemoradiotherapy may respond dramatically to further chemotherapy alone; or the masses may even disappear in the absence of further therapy, so called "tumor pseudoprogression" (Chamberlain et al., 2007). This confounding situation demonstrates a need for better assessment of tumor response.
Improvements in the ability to predict tumor behavior prior to the start of therapy would allow more efficient and effective tumor surveillance; better prognostication; and more appropriate assignment of patients to conventional, aggressive, or investigational therapies early in their clinical courses. This would provide huge economic and social benefits, and could afford decisive insights into brain tumor physiology and biology.
Similarly, the ability to identify, earlier and more accurately, whether individual patients were responding to therapy would allow prompt discontinuation of ineffectual treatments and institution of potentially more effective therapies.
Previous efforts using imaging for such tasks have generally been limited to a single modality (e.g. MRI) and/or single-tracer (e.g. FDG-PET). However, there is a significant and growing body of evidence that complementary imaging of multiple aspects of tumor physiology (i.e. using multiple PET tracers) can provide greatly enhanced information over imaging with a single modality or tracer alone. In solid tumors, complex interactions exist between blood flow, metabolic activity, and oxygen status which affect metastatic and proliferative activity. Heterogeneous tumors may contain both slow-growing and fast-growing regions that present different profiles of proliferation rates and amino acid uptake.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Both arms will undergo the same interventions, however, Group A will undergo three imaging sessions and Group B will undergo one imaging session
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: [18F]FLT, Drug: [18F]FluciclovineParticipants enrolled in Group A will undergo a maximum of 6 scans throughout this study. [18F]FLT- and [18F]Fluciclovine-PET/CT scans at up to three imaging time points: (1) prior to any tumor-directed therapy, (2) within 1-4 weeks after the conclusion of the intitial (~6-8 weeks) chemoradiotherapy, and (3) following suspected recurrence/progression versus treatment effect (pseudoprogression) shown with MRI, within 6 months of the completion of chemoradiation |
| Group B | Experimental | Drug: [18F]FLT, Drug: [18F]FluciclovineParticipants enrolled in Group B will undergo 2 scans as part of this study. [18F]FLT- and [18F]Fluciclovine-PET/CT scans will be acquired at a single timepoint, at the time of suspected pseudoprogression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Two adult patient groups will be eligible for inclusion in this study:
- Group A: Patients where there is compelling evidence, based on the MRI and/or CT imaging, that a high-grade primary brain tumor is present. Pathologic confirmation will occur with biopsy or surgery.
- Patients whose tumor is felt to be inoperable and a biopsy is performed but no surgery.
- Patients with a newly diagnosed primary malignant brain tumor (WHO Grade III or IV) who will be receiving chemoradiation and who either did not undergo surgical resection or underwent incomplete resection with residual tumor > 1.0 cm in greatest diameter by contrast MRI postoperatively.
- Group B: Patients with pathologically proven malignant brain tumor (WHO Grade III or IV glial-based tumors) who have undergone chemoradiation and have MRI-documented possible recurrence/progression versus treatment effect (pseudoprogression) within 6 months from the time of completion of chemoradiation.
Key exclusion criteria (6 listed)
- Patients with clinically significant signs of uncal herniation, such as acute pupillary enlargement, rapidly developing motor changes (over hours), or rapidly decreasing level of consciousness, are not eligible.
- Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals. Patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator's discretion.
- Patients who are pregnant or lactating or who suspect they might be pregnant. Serum pregnancy tests will be obtained prior to each set of multi-tracer PET scans in female patients that are not postmenopausal or surgically sterile.
- Adult patients who require monitored anesthesia for PET scanning.
- Patients who are too claustrophobic to undergo PET scanning.
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]FLTPET exams of [18F]FLT will be acquired in each patient at up to three time points: (1) prior to any tumor-directed therapy, either prior to surgery or immediately after surgery providing a complete surgical resection was not performed and confirmed by a post-operative contrast MRI scan where residual tumor > 1.0 cm in diameter was present and prior to any tumor-directed therapy; (2) at the conclusions of the initial (~6-8 weeks) chemoradiotherapy; and (3) patients with MRI-documented possible recurrence/progression versus treatment effect (pseudoprogression) within 6 months from the time of completion of chemoradiation. | Drug | Group A, Group B |
| [18F]FluciclovinePET exams of [18F]Fluciclovine will be acquired in each patient at up to three time points: (1) prior to any tumor-directed therapy, either prior to surgery or immediately after surgery providing a complete surgical resection was not performed and confirmed by a post-operative contrast MRI scan where residual tumor > 1.0 cm in diameter was present and prior to any tumor-directed therapy; (2) at the conclusions of the initial (~6-8 weeks) chemoradiotherapy; and (3) patients with MRI-documented possible recurrence/progression versus treatment effect (pseudoprogression) within 6 months from the time of completion of chemoradiation. | Drug | Group A, Group B |
Primary outcome
Count of Patients Showing >25% Reduction in Cerebral Uptake of [18F]FLT and [18F]Fluciclovine
Time frame: (1) Baseline [18F]FLT and [18F]Fluciclovine scans were acquired prior to initiating therapy, follow-up scans were acquired (2) 1-4 weeks following conclusion of initial chemoradiation, and (3) within 6 months of completion of chemoradiation.
Cerebral uptake of [18F]FLT and [18F]Fluciclovine measured in terms of SUVmax and SUVmean at each imaging time point ((1) prior to any tumor-directed therapy, (2) within 1-4 weeks after the conclusion of the initial (~6-8 weeks) chemoradiotherapy, and (3) following suspected recurrence/progression versus treatment effect (pseudoprogression) shown with MRI, within 6 months of the completion of chemoradiation). Using the first time point as baseline for the following two time points, the percent change is calculated from SUVmean and SUVmax for each of the radiotracers studied in this trial. This measure only applies to Group A, as multiple time points of scan data are needed to calculate change in uptake.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jeffrey Yap, PhD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing [18F]FLT and [18F]Fluciclovine in people with Brain Tumor, run by University of Utah 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 10 inclusion and 6 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: stopped early, as of the sponsor's last update on 27 Dec 2024. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Count of Patients Showing >25% Reduction in Cerebral Uptake of [18F]FLT and [18F]Fluciclovine (time frame: (1) Baseline [18F]FLT and [18F]Fluciclovine scans were acquired prior to initiating therapy, follow-up scans were acquired (2) 1-4 weeks following conclusion of initial chemoradiation, and (3) within 6 months of completion of chemoradiation.). 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 Dec 2024; AzTrials last refreshed its copy on 8 Nov 2026.