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Zr-89 Crefmirlimab Berdoxam and Immuno-PET for Resectable Brain Tumors

This study is looking at how well a special imaging agent, zirconium (Zr)-89 crefmirlimab berdoxam, combined with a type of scan called immuno-Positron Emission Tomography (immuno-PET), can identify immune cell activity in brain tumors that can be surgically removed. Researchers want to see if this method can accurately show the presence of certain immune cells (CD8 positive (+) tumor infiltrating lymphocytes or TILs) within the tumor. This could help doctors understand the tumor's immune response without needing repeated invasive biopsies. The study is enrolling 20 adults (18 years or older) who have a brain tumor diagnosis (like glioma, meningioma, or metastatic brain cancer) and are scheduled for surgery to remove their tumor. Success in this study means verifying that the Zr-89 crefmirlimab berdoxam immuno-PET accurately identifies immune cell activity in these tumors. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of 20 participants. The phase of the study is not specified.
What's involved
You would receive Zr-89 crefmirlimab berdoxam intravenously, undergo immuno-PET scans about 24 hours later, and have advanced MRI and MRI scans before your scheduled brain tumor surgery and biopsy.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed up until death after completing the study treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06650163

Zr-89 Crefmirlimab Berdoxam and Immuno-Positron Emission Tomography for the Imaging of Patients With Resectable Brain Tumors

Recruiting
PHASE1Ages 18+InterventionalDiagnostic
Jonsson Comprehensive Cancer Center
~20 participants
Updated 2026-02-05 on ClinicalTrials.gov
What's tested:Advanced Magnetic Resonance ImagingBrain SurgeryElectronic Health Record ReviewImmuno-Positron Emission Tomography ScanMagnetic Resonance ImagingStereotactic Biopsy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events
Measured over Up to 1 month
+1 more outcome measured

Conditions

Glioma
Malignant Brain Neoplasm
Meningioma
Metastatic Malignant Neoplasm in the Brain

Explore related trials

GliomaMalignant Brain NeoplasmMeningiomaMetastatic Malignant Neoplasm in the Brain

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Robert M Prins · PRINCIPAL_INVESTIGATOR · UCLA / Jonsson Comprehensive Cancer Center

Who to contact

Sichen Li
[email protected]
310-592-9091
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Male or female \>= 18 years of age
Documentation of a diagnosis of brain tumor including brain metastases, any grade of gliomas and meningiomas
The participant is scheduled for standard of care surgical tumor resection
The participant (or legally acceptable representative if applicable) provides written informed consent for the trial

Exclusion

Male or female \< 18 years of age
Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
Not medically cleared for surgery
Individuals who cannot tolerate MRI scan or PET/CT scan
Pregnant or breast-feeding women
Serum creatinine OR measured or calculated creatinine clearance (Glomerular filtration rate \[GFR\] can be use in place of creatinine or creatinine clearance \[CrCl\]) =\< 1.5 X institutional upper limit of normal (ULN) OR \>= 60mL/min for subjects with creatinine levels \> 1.5 X institutional ULN
Creatinine clearance should be calculated per institutional standard
Serum total bilirubin: =\< 1.5 X institutional ULN OR direct bilirubin =\< institutional ULN for subjects with total bilirubin levels \> 1.5 institutional ULN
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) =\< 2.5 X institutional ULN OR =\< 5 X institutional ULN for subjects with Gilberts syndrome
Albumin \>= 2.5 mg/dL
Patients with splenic dysfunction or post splenectomy
Any abnormalities that would be a contraindication to gadolinium-based contrast agent

What this trial measures

  • Incidence of adverse eventsUp to 1 month

    Analyses will be examined graphically and summarized by descriptive statistics. Data transformation may be applied to quantitative variables prior to analyses if deemed necessary.

  • Zirconium (Zr)-89 crefmirlimab berdoxam uptakeUp to 24 hours

    Will be determined by standardized uptake value-based quantitative measures relative to CD8+ tumor infiltrating lymphocytes density determined by immunohistochemistry from tumor biopsy samples. Analyses will be examined graphically and summarized by descriptive statistics. Data transformation may be applied to quantitative variables prior to analyses if deemed necessary. Will correlate immuno-positron emission tomography uptake with cytotoxic T-cell density across all tumor samples. Multivariate cox and log rank tests will be used to compare survival outcomes.