This phase I trial evaluates advanced imaging methods (dynamic contrast enhanced [DCE] magnetic resonance imaging [MRI] and dual-energy computed tomography [DECT]) for their ability to distinguish between true progression (the disease has actually gotten worse) and pseudoprogression (the disease appears to have gotten worse, but it actually has not) in patients with brain cancer. Glioma patients undergoing treatment often show worrisome new abnormal tissue growths on their follow-up MRI studies. These new growths may mean that the tumor has come back after a period of improvement, but frequently turn out to be pseudoprogression. Pseudoprogression is a treatment related change that looks like true disease progression on imaging scans. Routine MRI lacks the ability to tell the difference between true disease progression and pseudoprogression, which makes it difficult to manage the treatment of these patients. Advanced imaging techniques like DCE MRI and DECT may be more effective at differentiating between true disease progression and pseudoprogression, which may help doctors provide better care to patients with brain cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT06199479.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: Dawid Schellingerhout
Phone: 713-794-5673
PRIMARY OBJECTIVE:
I. To determine if advanced imaging findings can correlate with tissue changes in order to distinguish true progression from pseudoprogression.
SECONDARY OBJECTIVES:
I. To assess the feasibility of contrast clearance magnetic resonance (MR) (delayed longitudinal relaxation time [T1] enhanced MR) subtraction maps in distinguishing pseudoprogression from true progression.
II. To gather observational data for dual energy computed tomography (CT) imaging and delayed contrast clearance with dual energy CT in the assessment of glioma.
III. To correlate quantitative imaging biomarkers (derived from MR imaging data) along the biopsy tract with histological and clinical biomarkers.
IV. To observe clinical outcomes such as progression free survival and overall survival in the trial population and relate these to imaging findings.
OUTLINE:
Patients receive gadobutrol intravenously (IV) over 1-2 minutes then undergo DCE MRI over 1 hour. Patients also undergo a total of 3 DECT scans with and without IV iodine contrast agent over 10-15 minutes each. Patients then undergo biopsy within 2 weeks. Patients may optionally undergo collection of blood samples at screening.
After completion of study intervention, patients are followed up at 1 year and then annually for up to 5 years.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorDawid Schellingerhout