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New treatment option for Glioma
Official title Zr-89 Crefmirlimab Berdoxam and Immuno-Positron Emission Tomography for the Imaging of Patients With Resectable Brain Tumors
ClinicalTrials.gov ID: NCT06650163
What this study is testing
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
See the full eligibility criteria
- 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
- 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]) =\ = 60mL/min for people with creatinine levels \> 1.5...
- Creatinine clearance should be calculated per institutional standard
- Serum total bilirubin: =\ 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...
- Albumin \>= 2.5 mg/dL
- Patients with splenic dysfunction or post splenectomy
- Any abnormalities that would be a contraindication to gadolinium-based contrast agent
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.