Multiple SclerosisPhase 2NCT05062083
PET Imaging of Cyclooxygenase in Multiple Sclerosis
A Phase 2 study testing 11C-MC1, 11C-PS13 and Ketoprofen in people with Multiple Sclerosis, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
Background: Multiple sclerosis (MS) is an autoimmune disease that has no cure. MRI is the main tool used in the study and treatment of people with MS. Tracers have been developed for cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2), key enzymes that involved in neuroinflammation. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- 11C-MC1, 11C-PS13 and Ketoprofen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2022to 30 Jan 2024
- Phase
- Phase 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years and older.
- Female participants of childbearing potential must be using a medically acceptable means of contraception.
- Able to provide informed consent.
- In good general health as evidenced by medical history and physical examination.
- Enrolled under University of Maryland in Baltimore (UMB) protocol HP-00079860 (In vivo assessment of meningeal inflammation and its clinical impact in multiple sclerosis by 7 Tesla MRI), P.I. Daniel Harrison and have agreed to contact for future research.
- None
Who cannot join
- Any medical contraindication to the procedures performed in the study, or any current severe medical or psychiatric illness other than MS. This includes contraindications to Celecoxib, such as aspirin sensitive asthma, and contraindications to ketoprofen, such as hypersensitivity to ketoprofen or history of upper or lower gastrointestinal bleeding.
- Behavioral symptoms that would preclude the gathering of data for the study, or advanced disease such that subjects cannot provide assent.
- Clinically significant abnormalities on EKG or safety labs. This includes complete blood count (CBC); acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen); hepatic panel [alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin total, and bilirubin direct]; mineral panel (albumin, calcium, magnesium, phosphorus).
- MRI performed >180 days before or after the PET scan
- Have taken NSAIDs for two weeks prior to the PET scan. Have taken aspirin, corticosteroids (except for topical creams), or immunosuppressants (except for FDA approved disease-modifying therapy for MS) in the prior month.
- Have other major neurological or medical diseases that may cause cognitive dysfunction, such as structural brain diseases, metabolic diseases, paraneoplastic syndromes, infectious diseases, or other significant neurological abnormalities.
Show all 17Show fewer
- Have an unstable medical condition that, in the opinion of the investigators, makes participation unsafe (e.g., an active infection or untreated malignancy).
- Are unable to travel to the NIH.
- Have recent exposure to radiation related to research (e.g., PET from other research) that, when combined with this study, would be above the allowable limits.
- Have an inability to lie flat and/or lie still on the camera bed for at least two hours, including claustrophobia, overweight greater than the maximum for the scanner, and uncontrollable behavioral symptoms, which will be screened by an interview with the patient and/or caregiver during the screening visit.
- Pregnancy
- HIV infection
- Be National Institute of Mental Health (NIMH) staff or an NIH employee who is a subordinate/relative/co-worker of the investigators.
- Because this protocol has more than minimal risk from radiation exposure without possibility of direct benefit, inclusion of children is not appropriate.
- Pregnant women will be excluded because this protocol involves exposure to ionizing radiation. Lactating women will be excluded because radioisotopes may be excreted in milk.
- Persons with HIV infection are excluded because HIV infection itself may cause neuroinflammation, and we wish to specifically study the effect of MS on neuroinflammation.
- Exclusion of Participation of NIH Staff or family members of study team members NIH staff and family members of study team members may not be enrolled in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: PET Imaging of Cyclooxygenases in Multiple Sclerosis
Background:
Multiple sclerosis (MS) is an autoimmune disease that has no cure. MRI is the main tool used in the study and treatment of people with MS. Tracers have been developed for cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2), key enzymes that involved in neuroinflammation. Researchers want to explore the role inflammation plays in MS and see if COX-1 and COX-2 are measurable in the brains of people with the disease.
Read more
Objective:
To see if COX-1 and COX-2 are detectable in the brains of individuals with MS.
Eligibility:
People ages 18 and older with MS who are otherwise healthy.
Design:
Participants will be screened with their medical history and a physical exam. They will have an EKG to check the electrical activity of the heart.
Participants study involvement requires 3 to 5 visits and will last between 2 weeks and 4 months.
Participants will have two positron emission tomography (PET) scans of the brain for each tracer. Scans of the same tracer might occur on the same day or on separate days. A small amount of a radioactive chemical will be injected through an intravenous catheter. A needle will be used to guide a thin plastic tube into an arm vein. The needle will be removed. Only the catheter will be left in the vein. The PET scanner is shaped like a doughnut. Participants will lie on a bed that slides in and out of the scanner. They will wear a plastic mask molded to fit the head. The scan will last about 90 minutes for each tracer. Participants will receive the medication ketoprofen or celecoxib orally about 2 hours before the second scan.
Participants will have blood tests.
Participants must avoid certain medications a month prior to the PET scans.
Read the detailed description
Study Description: This study will examine whether cyclooxygenase 1 (COX-1) and cyclooxygenase 2 (COX-2) are elevated in the brain of individuals with Multiple Sclerosis (MS)
Objectives: To determine whether COX-1 and COX-2 are detectable in the brains of individuals with MS.
Endpoints:
Primary endpoint: Calculation of COX-1 and COX-2 densities from [11C]PS13 and [11C]MC1 PET scans, respectively, using baseline scans and scans after blockade with ketoprofen and celecoxib, respectively.
Secondary endpoint: 1) Comparison of [11C]PS13 and [11C]MC1 specific uptake in different types of MS lesions (active, chronic active, inactive) and in normal white matter. 2) Comparison of [11C]PS13 and [11C]MC1 specific uptake in the brain lesions of the same subjects
- Conditions
- Multiple Sclerosis
- Being tested
- 11C-MC1, 11C-PS13, Ketoprofen, Celecoxib
- Keywords
- PET Imaging, Multiple Sclerosis, Neuroinflammation, Neurological Symptoms, Cyclooxygenases
- Medical subject headings
- Multiple Sclerosis, Neuroinflammatory Diseases, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
11C-MC1Drug
Up to 20 mCi injected IV followed by PET scanning
11C-PS13Drug
Up to 20 mCi injected IV followed by PET Scanning
KetoprofenDrug
Ketoprofen 75 mg orally once
CelecoxibDrug
celecoxib 600 mg orally once
| Study group | Role | What they receive |
|---|---|---|
| Participants with multiple sclerosis | Experimental | Participants had two brain positron emission tomography (PET) scan visits. In one visit, participants had a baseline [11C]PS13 scan followed by a second [11C]PS13 scan after blockade with ketoprofen 75 mg orally. In another visit, participants had baseline [11C]MC1 scan followed by a second scan with [11C]MC1 after blockade by a dose of celecoxib 600 mg orally. Participants receive injection of up to 20 millicurie (mCi) of [11C]PS13 or [11C]MC1 during each scan. Receives: Drug: 11C-MC1; Drug: 11C-PS13; Drug: Ketoprofen; Drug: Celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard Uptake Value Ratio (SUVR) of Lesions With Injection of [11C]PS13
Standard uptake value (SUV) was measured by averaging the SUV of all lesion voxels or tissue contralateral to lesion voxels in the PET image with injection of [11C]PS13. The SUVR was calculated by averaging the SUV ratio between lesion or tissue contralateral to lesion voxels and the caudate from 60-90 minutes after the start of the PET scan.
Measured: 60-90 minutes after the start of PET scan
Standard Uptake Value Ratio (SUVR) of Lesions With Injection of [11C]MC1
Standard uptake value (SUV) was measured by averaging the SUV of all lesion voxels or tissue contralateral to lesion voxels in the PET image with injection of [11C]MC1. The SUVR was calculated by averaging the SUV ratio between lesion or tissue contralateral to lesion voxels and the cerebellum from 60-90 minutes after the start of the PET scan.
Measured: 60-90 minutes after the start of PET scan
Standard Uptake Value Ratio (SUVR) of Lesions With Injection of [11C]PS13 After Blockade With Ketoprofen
Calculation of standard uptake value (SUV) by averaging the SUV of all lesion voxels or tissue contralateral to lesion voxels in the PET image with injection of [11C]PS13 after blockade with ketoprofen. Calculation of SUVR by averaging the SUV ratio between lesion or tissue contralateral to lesion voxels and the caudate from 60-90 minutes after the start of the PET scan.
Measured: 60-90 minutes after the start of PET scan
Standard Uptake Value Ratio (SUVR) of Lesions With Injection of [11C]MC1 After Blockade With Celecoxib
Calculation of standard uptake value (SUV) by averaging the SUV of all lesion voxels or tissue contralateral to lesion voxels in the PET image with injection of [11C]MC1 after blockade with celecoxib. Calculation of SUVR by averaging the SUV ratio between lesion or tissue contralateral to lesion voxels and the cerebellum from 60-90 minutes after the start of the PET scan.
Measured: 60-90 minutes after the start of PET scan
Secondary outcomes (2)
Standard Uptake Value Ratio (SUVR) of Chronic Active Lesions With Injection of [11C]PS13
Chronic active lesion is defined as the white matter lesion with paramagnetic outer rim in quantitative susceptibility maps (QSM). Standard uptake value (SUV) was measured by averaging the SUV of chronic active lesion voxels or contralateral normal appearing brain tissues in the [11C]PS13 PET image. The SUVR was calculated by averaging the SUV ratio between chronic active lesion or tissue contralateral to lesion voxels and the caudate from 60-90 minutes after the start of the PET scan.
Measured: 60-90 minutes after the start of PET scan
Standard Uptake Value Ratio (SUVR) of Chronic Active Lesions With Injection of [11C]MC1
Chronic active lesion is defined as the white matter lesion with paramagnetic outer rim in quantitative susceptibility maps (QSM). Standard uptake value (SUV) was measured by averaging the SUV of chronic active lesion voxels or contralateral normal appearing brain tissues in the [11C]MC1 PET image. The SUVR was calculated by averaging the SUV ratio between chronic active lesion or tissue contralateral to lesion voxels and the cerebellum from 60-90 minutes after the start of the PET scan.
Measured: 60-90 minutes after the start of PET scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start7 Jun 2022
- Primary completion5 Sep 2023
- Study completion30 Jan 2024
Why it stopped: due to futility
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 Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of Maryland
- Responsible party
- Sponsor
- Investigators
- Robert B Innis, M.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05062083
- Sponsor's protocol ID
- 10000483
- Other IDs
- 000483-M
- Status last verified
- Jan 2024
- First submitted
- 29 Sep 2021
- Last updated
- 27 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: .This study will also comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET Imaging of Cyclooxygenases in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05062083
- Acronym / sponsor ID
- 10000483
- Conditions
- Multiple Sclerosis
- Keywords
- PET Imaging, Multiple Sclerosis, Neuroinflammation, Neurological Symptoms, Cyclooxygenases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to futility
- Enrolment
- 7 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Collaborators
- University of Maryland
- Study start
- 7 Jun 2022 (actual)
- Primary completion
- 5 Sep 2023 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 30 Sep 2021 (actual)
- Results
- Posted 27 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Multiple sclerosis (MS) is an autoimmune disease that has no cure. MRI is the main tool used in the study and treatment of people with MS. Tracers have been developed for cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2), key enzymes that involved in neuroinflammation. Researchers want to explore the role inflammation plays in MS and see if COX-1 and COX-2 are measurable in the brains of people with the disease.
Objective:
To see if COX-1 and COX-2 are detectable in the brains of individuals with MS.
Eligibility:
People ages 18 and older with MS who are otherwise healthy.
Design:
Participants will be screened with their medical history and a physical exam. They will have an EKG to check the electrical activity of the heart.
Participants study involvement requires 3 to 5 visits and will last between 2 weeks and 4 months.
Participants will have two positron emission tomography (PET) scans of the brain for each tracer. Scans of the same tracer might occur on the same day or on separate days. A small amount of a radioactive chemical will be injected through an intravenous catheter. A needle will be used to guide a thin plastic tube into an arm vein. The needle will be removed. Only the catheter will be left in the vein. The PET scanner is shaped like a doughnut. Participants will lie on a bed that slides in and out of the scanner. They will wear a plastic mask molded to fit the head. The scan will last about 90 minutes for each tracer. Participants will receive the medication ketoprofen or celecoxib orally about 2 hours before the second scan.
Participants will have blood tests.
Participants must avoid certain medications a month prior to the PET scans.
Detailed description
Study Description: This study will examine whether cyclooxygenase 1 (COX-1) and cyclooxygenase 2 (COX-2) are elevated in the brain of individuals with Multiple Sclerosis (MS)
Objectives: To determine whether COX-1 and COX-2 are detectable in the brains of individuals with MS.
Endpoints:
Primary endpoint: Calculation of COX-1 and COX-2 densities from [11C]PS13 and [11C]MC1 PET scans, respectively, using baseline scans and scans after blockade with ketoprofen and celecoxib, respectively.
Secondary endpoint: 1) Comparison of [11C]PS13 and [11C]MC1 specific uptake in different types of MS lesions (active, chronic active, inactive) and in normal white matter. 2) Comparison of [11C]PS13 and [11C]MC1 specific uptake in the brain lesions of the same subjects
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with multiple sclerosis | Experimental | Drug: 11C-MC1, Drug: 11C-PS13, Drug: Ketoprofen, Drug: CelecoxibParticipants had two brain positron emission tomography (PET) scan visits. In one visit, participants had a baseline [11C]PS13 scan followed by a second [11C]PS13 scan after blockade with ketoprofen 75 mg orally. In another visit, participants had baseline [11C]MC1 scan followed by a second scan with [11C]MC1 after blockade by a dose of celecoxib 600 mg orally. Participants receive injection of up to 20 millicurie (mCi) of [11C]PS13 or [11C]MC1 during each scan. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 years and older.
- Female participants of childbearing potential must be using a medically acceptable means of contraception.
- Able to provide informed consent.
- In good general health as evidenced by medical history and physical examination.
- Enrolled under University of Maryland in Baltimore (UMB) protocol HP-00079860 (In vivo assessment of meningeal inflammation and its clinical impact in multiple sclerosis by 7 Tesla MRI), P.I. Daniel Harrison and have agreed to contact for future research.
Key exclusion criteria (17 listed)
- Any medical contraindication to the procedures performed in the study, or any current severe medical or psychiatric illness other than MS. This includes contraindications to Celecoxib, such as aspirin sensitive asthma, and contraindications to ketoprofen, such as hypersensitivity to ketoprofen or history of upper or lower gastrointestinal bleeding.
- Behavioral symptoms that would preclude the gathering of data for the study, or advanced disease such that subjects cannot provide assent.
- Clinically significant abnormalities on EKG or safety labs. This includes complete blood count (CBC); acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen); hepatic panel [alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin total, and bilirubin direct]; mineral panel (albumin, calcium, magnesium, phosphorus).
- MRI performed >180 days before or after the PET scan
- Have taken NSAIDs for two weeks prior to the PET scan. Have taken aspirin, corticosteroids (except for topical creams), or immunosuppressants (except for FDA approved disease-modifying therapy for MS) in the prior month.
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 |
|---|---|---|
| 11C-MC1Up to 20 mCi injected IV followed by PET scanning | Drug | Participants with multiple sclerosis |
| 11C-PS13Up to 20 mCi injected IV followed by PET Scanning | Drug | Participants with multiple sclerosis |
| KetoprofenKetoprofen 75 mg orally once | Drug | Participants with multiple sclerosis |
| Celecoxibcelecoxib 600 mg orally once | Drug | Participants with multiple sclerosis |
Primary outcome
Standard Uptake Value Ratio (SUVR) of Lesions With Injection of [11C]PS13
Time frame: 60-90 minutes after the start of PET scan
Standard uptake value (SUV) was measured by averaging the SUV of all lesion voxels or tissue contralateral to lesion voxels in the PET image with injection of [11C]PS13. The SUVR was calculated by averaging the SUV ratio between lesion or tissue contralateral to lesion voxels and the caudate from 60-90 minutes after the start of the PET scan.
Standard Uptake Value Ratio (SUVR) of Lesions With Injection of [11C]MC1
Time frame: 60-90 minutes after the start of PET scan
Standard uptake value (SUV) was measured by averaging the SUV of all lesion voxels or tissue contralateral to lesion voxels in the PET image with injection of [11C]MC1. The SUVR was calculated by averaging the SUV ratio between lesion or tissue contralateral to lesion voxels and the cerebellum from 60-90 minutes after the start of the PET scan.
Standard Uptake Value Ratio (SUVR) of Lesions With Injection of [11C]PS13 After Blockade With Ketoprofen
Time frame: 60-90 minutes after the start of PET scan
Calculation of standard uptake value (SUV) by averaging the SUV of all lesion voxels or tissue contralateral to lesion voxels in the PET image with injection of [11C]PS13 after blockade with ketoprofen. Calculation of SUVR by averaging the SUV ratio between lesion or tissue contralateral to lesion voxels and the caudate from 60-90 minutes after the start of the PET scan.
Standard Uptake Value Ratio (SUVR) of Lesions With Injection of [11C]MC1 After Blockade With Celecoxib
Time frame: 60-90 minutes after the start of PET scan
Calculation of standard uptake value (SUV) by averaging the SUV of all lesion voxels or tissue contralateral to lesion voxels in the PET image with injection of [11C]MC1 after blockade with celecoxib. Calculation of SUVR by averaging the SUV ratio between lesion or tissue contralateral to lesion voxels and the cerebellum from 60-90 minutes after the start of the PET scan.
2 secondary outcomes
Standard Uptake Value Ratio (SUVR) of Chronic Active Lesions With Injection of [11C]PS13
Time frame: 60-90 minutes after the start of PET scan
Standard Uptake Value Ratio (SUVR) of Chronic Active Lesions With Injection of [11C]MC1
Time frame: 60-90 minutes after the start of PET scan
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. .This study will also comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule.
Related trials for Multiple Sclerosis
RecruitingPhase 4
Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities
Centreal Neurological Condition, Acquired Brain Injury (Including Stroke)
Active, not recruiting
Myrosinase Bioactivated Gglucoraphanin for the Treatment of Neurodegenerative Diseases (GRA-MYR-ND)
PARKINSON DISEASE (Disorder), Multiple Sclerosis (MS) - Relapsing-remitting
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
Not yet recruitingPhase 1
A Study of Subcutaneously Administered RO7845860 in Participants With Relapsing Multiple Sclerosis
Relapsing Multiple Sclerosis
Recruiting
Virtual Reality Versus Mental Practice On Balance And Gait In Patients With Multiple Sclerosis
Multiple Sclerosis
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.
Robert B Innis, M.D. principal investigator
National Institute of Mental Health (NIMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 11C-MC1, 11C-PS13 and Ketoprofen in people with Multiple Sclerosis, run by National Institute of Mental Health (NIMH) 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 6 inclusion and 17 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 Jun 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 phase mean?
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 Jun 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?
Standard Uptake Value Ratio (SUVR) of Lesions With Injection of [11C]PS13 (time frame: 60-90 minutes after the start of PET scan). The study lists 4 primary outcomes in all. 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 Jun 2024; AzTrials last refreshed its copy on 6 Nov 2026.