Inflammation in Primary and Secondary Malignancies of the Central Nervous System Using [C-11]-CS1P1

Summary

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.

Interventions

• [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 · DEVICE

  Optional

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Women who are currently pregnant or breastfeeding
* Any condition that, in the opinion of the Sponsor-Investigator or designee could increase risk to the participant, limit the participant's ability to tolerate the research procedures or interfere with the collection of the data (e.g., advanced renal or liver failure)
* Current or recent (within 12 months prior to screening) participation in research studies involving radioactive agents such that the total research-related radiation dose to the participant in any given year would exceed the limits set forth in the U.S. Code of Federal Regulations (CFR) Title 21 Section 361.1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=361.1.

Sites (1)

• Washington University School of Medicine, St Louis, Missouri · RECRUITING