Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06448286
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-03
Brief Title:
PH Weighted Chemical Exchange Saturation Transfer MRI-Based Surgical Resection to Improve Survival in Patients With Glioblastoma
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
PH Weighted Chemical Exchange Saturation Transfer Based Surgical Resections of Glioblastoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-01961 | REGISTRY | CTRP Clinical Trial Reporting Program | None |