Inflammation in Primary and Secondary Malignancies of the Central Nervous System Using [C-11]-CS1P1
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorWashington University School of Medicine
About this trial
Adult patients with primary or secondary central nervous system malignancies will be invited to undergo a baseline \[C-11\]-CS1P1 PET scan and a follow-up scan within 24 months of the baseline scan (preferably within 6-months post-treatment).The study will describe patterns of tracer uptake in tumors and normal brain and explore how these patterns relate to MRI findings, treatments received, and clinical outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female, any race
Age ≥ 18 years
Capable of providing written informed consent OR having a legally authorized representative (LAR) to provide informed consent for volunteering to undergo research procedure
Has a clinical, radiographic, or pathological diagnosis of primary or secondary CNS malignancy that has not been treated with radiotherapy
Disqualifiers
Hypersensitivity to [C-11]-CS1P1 or any of its excipients
Contraindications to PET, CT or MRI (e.g. certain incompatible electronic medical devices, inability to lie still for extended periods) that make it potentially unsafe for the individual to participate
Prior cranial radiotherapy
Severe claustrophobia that would require general anesthesia
Trial design
Design model
Single group
Treatments tested in this trial
[C-11]-CS1P1
Drug* The investigational radiotracer \[C-11\]-CS1P1 is an S1P1 PET imaging agent. * The PET imaging will be acquired either in a PET/MR scanner or the PET/CT scanner
Brain MRI
DeviceOptional
Treatment groups
104 Participants
are divided into 1 treatment groupGroup A: [C-11]-CS1P1 PETExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
[C-11]CS1P1 Standardized uptake value (SUV) ratio of tumor to non-tumor regions of interest (ROIs)
\[C-11\]CS1P1-SUV ratio at the baseline and associated 95% confidence interval (CI) will be calculated.
Time frame
BaselineSecondary outcomes
1
Follow-up changes from the baseline in [C-11]CS1P1 SUV ratio
\[C-11\]CS1P1-SUV ratio at the follow up scan and change from the baseline as well as their associated 95% confidence interval (CI) will be calculated.
Time frame
Baseline and 24 months2
Number of participants with adverse events
Measured and graded per CTCAE v 6.0.
Time frame
From time of scan through 2-3 daysSponsors and contacts
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Source ClinicalTrials.gov