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NCT06650163 · ClinicalTrials.gov registry record · Phase 1
Zr-89 Crefmirlimab Berdoxam and Immuno-Positron Emission Tomography for the Imaging of Patients With Resectable Brain Tumors
A Phase 1 study of Glioma and Metastatic Malignant Neoplasm in the Brain, sponsored by Jonsson Comprehensive Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT06650163: Recruiting Phase 1 study of Glioma and Metastatic Malignant Neoplasm in the Brain, sponsored by Jonsson Comprehensive Cancer Center.
NCT06650163 is a Phase 1 study of Glioma and Metastatic Malignant Neoplasm in the Brain that is actively recruiting participants, run by Jonsson Comprehensive Cancer Center. The registered enrollment target is 20 participants, below the 210-participant average among 87 other Glioma trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06650163, a Phase 1 study of Glioma and Metastatic Malignant Neoplasm in the Brain, is actively recruiting participants, sponsored by Jonsson Comprehensive Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies how well zirconium (Zr)-89 crefmirlimab berdoxam and immuno-positron emission tomography (PET) identifies areas of immune cell activity in patients with brain tumors that can be removed by surgery (resectable). One important predictor of the immune response is the presence and change in CD8 positive (+) tumor infiltrating lymphocytes (TIL) cells. Identifying the presence and changes in CD8+ cells can be challenging, particularly for participants with central nervous system (CNS) tumors, and usually requires invasive procedures such as repeat tissue biopsies, which may not accurately represent the immune status of the entire tumor. Zr-89 crefmirlimab berdoxam is known as a radioimmunoconjugate which consists of a radiolabeled anti-CD8+ minibody whose uptake can be imaged with PET. Upon administration, Zr 89 crefmirlimab berdoxam specifically targets and binds to the CD8+ cells. This enables PET imaging and may detect CD8+ T-cell distribution and activity and may help determine the patient's response to cancer immunotherapeutic agents more accurately. Giving Zr-89 crefmirlimab berdoxam along with undergoing immuno-PET imaging may work better at identifying immune cell activity in patients with resectable brain tumors.
Primary Outcome
Analyses will be examined graphically and summarized by descriptive statistics. Data transformation may be applied to quantitative variables prior to analyses if deemed necessary.
Conditions Studied
Interventions
- PROCEDURE Magnetic Resonance Imaging
- OTHER Electronic Health Record Review
- PROCEDURE Advanced Magnetic Resonance Imaging
- PROCEDURE Brain Surgery
- PROCEDURE Immuno-Positron Emission Tomography Scan
Study Locations (1)
California
- UCLA / Jonsson Comprehensive Cancer Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-12-05 |
| Est. Completion | 2028-01-31 |
| Phase | Phase 1 |
What NCT06650163 shows while recruiting
NCT06650163 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 210-participant average among 87 other Glioma trials with a reported enrollment target (90% lower).
The record links to 4 conditions, with Glioma appearing as the primary indexed condition, and to 5 interventions - of which Magnetic Resonance Imaging is the first listed.
NCT06650163 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06650163 about?
NCT06650163 is a clinical study titled "Zr-89 Crefmirlimab Berdoxam and Immuno-Positron Emission Tomography for the Imaging of Patients With Resectable Brain Tumors". This phase I trial studies how well zirconium (Zr)-89 crefmirlimab berdoxam and immuno-positron emission tomography (PET) identifies areas of immune cell activity in patients with brain tumors that can be removed by surgery (resectable). One important predictor of the immune response is the presence...
What is the current status of trial NCT06650163?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2024-12-05. Estimated completion is 2028-01-31.
What conditions does trial NCT06650163 study?
This clinical trial studies the following conditions: Glioma, Metastatic Malignant Neoplasm in the Brain, Meningioma, Malignant Brain Neoplasm.
What interventions are being tested in trial NCT06650163?
The interventions under investigation include: Magnetic Resonance Imaging (PROCEDURE), Electronic Health Record Review (OTHER), Advanced Magnetic Resonance Imaging (PROCEDURE), Brain Surgery (PROCEDURE), Immuno-Positron Emission Tomography Scan (PROCEDURE).
Who is sponsoring clinical trial NCT06650163?
This trial is sponsored by Jonsson Comprehensive Cancer Center, which has 321 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06650163 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06650163's enrollment target sits among peer trials
20 65th of 87 higher than 18 of 87 other Glioma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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