Evaluation of FLT PET and MRI as Imaging Biomarkers of Early Treatment Response in Patients With Glioblastoma
Completed
Conditions studied: Glioblastoma
In brief
Glioblastoma is the most common primary malignant neoplasm of the adult brain. Even after multimodal therapy, outcomes remain poor, with a median survival of one year. Although advanced imaging methods have been suggested as molecular markers of prognosis and therapeutic response, these methods have not been validated for clinical use. In this exploratory, imaging-based, trial, thirty patients with a pathological diagnosis of glioblastoma will be followed prospectively for two years. The study examines how PET and MR imaging signals change following administration of a standard radio-chemotherapy treatment regimen to determine whether these imaging modalities can provide early indicators of response to therapeutic intervention. The investigators hypothesize that decreases in uptake of an investigational 18F-FLT PET tracer following treatment with radiation and chemotherapy will be a reliable predictor of glioblastoma response. In a more exploratory fashion, the investigators also will identify changes in diffusion and hypoxia MR imaging that may also correlate well with treatment response.
Key facts
- Study ID
- NCT01880008
- Run by
- Washington University School of Medicine
- People needed
- 5
- Starts
- 2008-04-01
- Expected to finish
- 2012-08-01
- Last updated by the study team
- 2013-06-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult patients (> 18 yo) with a pathological diagnosis of malignant glioma (WHO grades III and IV, including all histological subtypes)
- Surgical intervention includes subtotal resection or biopsy with MRI evidence of residual disease after resection
- Patients with plan to undergo standard chemotherapy and radiation protocols including a combination of fractionated radiation and temozolomide
- Preoperative Karnofsky performance score (KPS) of > 60
- Willingness of patient and his/her partner to use contraceptive measures for duration of trial that will include PET studies.
You may not qualify if…
- Patient refuses adjunctive therapy
- Pregnancy
- Karnofsky scale < 60
- Inability to undergo MR imaging studies
- Estimated GFR ≤ 60 ml/min (using GFR = 0.85*[140 - age(y)]*[bodyweight(kg)]/[72*Cr(mg/dl)] for women and GFR = [140 - age(y)]*[bodyweight(kg)]/[72*Cr(mg/dl)] for men).
- Inability or unwillingness to follow instructions for both PET and MR imaging sessions.
Where it is running
- Washington University School of Medicine/Barnes-Jewish Hospital — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
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