Trial Title:
PH Weighted Chemical Exchange Saturation Transfer MRI-Based Surgical Resection to Improve Survival in Patients With Glioblastoma
NCT ID:
NCT06448286
Condition:
Glioblastoma
Conditions: Official terms:
Glioblastoma
Temozolomide
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking description:
The patient, investigators and research staff will be blinded.
Intervention:
Intervention type:
Procedure
Intervention name:
Chemical Exchange Saturation Transfer Magnetic Resonance Imaging
Description:
Undergo CEST MRI
Arm group label:
Group II (CEST MRI based surgical resection)
Other name:
Chemical Exchange Saturation Transfer MRI
Intervention type:
Procedure
Intervention name:
Contrast-enhanced Magnetic Resonance Imaging
Description:
Undergo contrast-enhanced MRI
Arm group label:
Group I (standard of care surgical resection)
Other name:
CONTRAST ENHANCED MRI
Other name:
Contrast-enhanced MRI
Other name:
MRI With Contrast
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Group I (standard of care surgical resection)
Arm group label:
Group II (CEST MRI based surgical resection)
Other name:
Magnetic Resonance
Other name:
Magnetic Resonance Imaging (MRI)
Other name:
Magnetic resonance imaging (procedure)
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
MRIs
Other name:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Other name:
sMRI
Other name:
Structural MRI
Intervention type:
Radiation
Intervention name:
Radiation Therapy
Description:
Undergo standard of care radiation therapy
Arm group label:
Group I (standard of care surgical resection)
Arm group label:
Group II (CEST MRI based surgical resection)
Other name:
Cancer Radiotherapy
Other name:
Energy Type
Other name:
ENERGY_TYPE
Other name:
Irradiate
Other name:
Irradiated
Other name:
Irradiation
Other name:
Radiation
Other name:
Radiation Therapy, NOS
Other name:
Radiotherapeutics
Other name:
Radiotherapy
Other name:
RT
Other name:
Therapy, Radiation
Intervention type:
Procedure
Intervention name:
Surgical Procedure
Description:
Undergo surgical resection
Arm group label:
Group I (standard of care surgical resection)
Arm group label:
Group II (CEST MRI based surgical resection)
Other name:
Operation
Other name:
Surgery
Other name:
Surgery Type
Other name:
Surgery, NOS
Other name:
Surgical
Other name:
Surgical Intervention
Other name:
Surgical Interventions
Other name:
Surgical Procedures
Other name:
Type of Surgery
Intervention type:
Drug
Intervention name:
Temozolomide
Description:
Given PO
Arm group label:
Group I (standard of care surgical resection)
Arm group label:
Group II (CEST MRI based surgical resection)
Other name:
CCRG-81045
Other name:
Gliotem
Other name:
Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-
Other name:
M & B 39831
Other name:
M and B 39831
Other name:
Methazolastone
Other name:
RP-46161
Other name:
SCH 52365
Other name:
Temcad
Other name:
Temizole
Other name:
Temodal
Other name:
Temodar
Other name:
Temomedac
Other name:
TMZ
Summary:
This phase III trial compares pH weighted chemical exchange saturation transfer (CEST)
magnetic resonance imaging (MRI)-based surgical resections to standard of care surgical
resections for the treatment of patients with glioblastoma. Standard of care therapy for
glioblastoma is surgery to remove tumor tissue that enhances on standard MRI imaging,
however, it has been shown that significant tumor burden exists in the region around the
tumor tissue that does not enhance with standard MRI. MRI is a procedure in which radio
waves and a powerful magnet linked to a computer are used to create detailed pictures of
areas inside the body. These pictures can show the difference between normal and tumor
tissue. CEST MRI is a technique that uses differences in the tissue environment, like
protein concentration or intracellular pH, to generate contrast differences. CEST MRI may
identify tumor tissue that does not enhance with standard of care MRI. PH weighted CEST
MRI based surgical resection may be more effective compared to standard of care surgical
resection in treating patients with glioblastoma.
Detailed description:
PRIMARY OBJECTIVE:
I. To assess the efficacy of potential of hydrogen (pH) sensitive MRI based resections of
glioblastoma.
SECONDARY OBJECTIVE:
I. To find surgical and adjuvant therapies to treat infiltrating glioblastoma cells.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients undergo surgical resection with standard intraoperative guidance using
contrast-enhanced MRI. Patients also undergo post operative standard of care radiation
therapy over 30 fractions and receive standard of care temozolomide orally (PO) for 6
weeks. Additionally, patients undergo MRI during follow up.
GROUP II: Patients undergo surgical resection with intraoperative guidance using CEST
MRI. Patients also undergo post operative standard of care radiation therapy over 30
fractions and receive standard of care temozolomide PO for 6 weeks. Additionally,
patients undergo MRI during follow up.
After completion of study treatment, patients are followed up at months 3, 6, 12, and 24.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Male or female ≥ 18 years of age
- Documentation of a newly diagnosed World Health Organization (WHO) grade IV
glioblastoma as evidenced by clinical features and imaging data
- Written informed consent (and assent when applicable) obtained from subject or
subject's legal representative and ability for subject to comply with the
requirements of the study
Exclusion Criteria:
- 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
- Previous treatment (any chemotherapy, molecular therapy, immunotherapy, or radiation
therapy)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UCLA / Jonsson Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Contact:
Last name:
Kunal S. Patel
Phone:
310-825-5111
Email:
kunalpatel@mednet.ucla.edu
Investigator:
Last name:
Kunal S. Patel
Email:
Principal Investigator
Start date:
December 1, 2024
Completion date:
December 1, 2027
Lead sponsor:
Agency:
Jonsson Comprehensive Cancer Center
Agency class:
Other
Source:
Jonsson Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06448286
