Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID07462507

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

Led by Washington University School of Medicine · Updated on 2026-04-21

104

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying adults with primary or secondary central nervous system malignancies, such as gliomas and brain metastases, to evaluate an investigational PET radiotracer called [C-11]-CS1P1. This tracer may help provide additional information about tumor activity, treatment response, and the tumor environment in these brain cancers. The study is a prospective, single-arm interventional imaging trial aiming to explore how tracer uptake patterns relate to MRI findings, treatments received, and clinical outcomes. Participants will receive a baseline [C-11]-CS1P1 PET scan using a PET/CT or PET/MR scanner after intravenous injection of the tracer. The scan acquisition will last up to 90 minutes. An optional brain MRI may also be performed. Participants will be invited for one follow-up PET scan within 24 months of the baseline scan, preferably within about 6 months after treatment, to assess changes in tracer uptake over time. Clinical care will not be affected by study participation. During the study, researchers will collect quantitative PET data such as standardized uptake values and tumor-to-background ratios, along with qualitative assessments of tracer patterns. These measures will be compared with MRI features, treatment history, and clinical outcomes including disease progression and survival. Participants will be monitored for any adverse events related to tracer administration and radiation exposure. The study aims to generate preliminary data to guide future research using [C-11]-CS1P1 PET imaging in central nervous system cancers.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female, any race
  • Age 18 years or older
  • Able to provide written informed consent or have a legally authorized representative to consent
  • Clinical, radiographic, or pathological diagnosis of primary or secondary central nervous system malignancy not treated with radiotherapy
Not Eligible

You will not qualify if you...

  • Allergy or hypersensitivity to [C-11]-CS1P1 or its ingredients
  • Contraindications to PET, CT, or MRI that make participation unsafe (e.g., incompatible devices, inability to remain still)
  • Prior cranial radiotherapy
  • Severe claustrophobia requiring general anesthesia
  • Pregnant or breastfeeding women
  • Any condition increasing risk, limiting tolerance, or interfering with data collection (e.g., advanced kidney or liver failure)
  • Recent participation in studies with radioactive agents exceeding regulatory radiation limits

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Day of baseline imaging

Participants undergo a baseline [C-11]-CS1P1 PET scan to evaluate disease activity and tumor characteristics. An optional brain MRI may also be performed during this time.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 24 months after baseline

Participants are invited to return for one follow-up [C-11]-CS1P1 PET scan within 24 months, preferably within approximately 6 months after treatment, to assess changes related to disease and treatment course.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Washington University School of Medicine

St Louis, Missouri, United States, 63110

Actively Recruiting

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Research Team

T

Tammie L.S. Benzinger, M.D., Ph.D.

J

Jayashree Rajamanickam

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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