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NCT Number: NCT01880008

Evaluation of FLT PET and MRI as Imaging Biomarkers of Early Treatment Response in Patients With Glioblastoma

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.

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Key information

Conditions

Glioblastoma Astrocytoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine/Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

About this study

Patients with glioblastoma will be imaged with FLT PET/CT followed by MRI. The FLT uptake will be correlated with advanced MRI markers of tumor progression to determine the ability of using FLT PET and MRI for predicting response to treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Change in FLT uptake, measured by SUV tumor/SUV normal contralateral white matter

    Time frame: Before and after chemotherapy/radiation therapy

    Determines the change in FLT uptake as a result of chemotherapy/radiation therapy

Secondary outcomes

  1. Survival

    Time frame: 2 years

    Number of months from date of diagnosis to date of death.

  2. Ki-67

    Time frame: At diagnosis

    Ki-67 proliferation index on tumor specimens obtained at biopsy or from surgical resection specimen

  3. Radiographic progression defined by MacDonald criteria

    Time frame: 2 years

    MacDonald criteria to be used to determine whether tumor progress or not during the course of this study

  4. O(6)-methylguanine DNA-methyltransferase (MGMT) activity

    Time frame: prior to treatment

    MGMT activity from tumor specimens

  5. Time to progression

    Time frame: 2 years

    Months after completing radiation treatment to first instance of radiographic progression

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Barnes-Jewish Hospital

Registry information

Official study title

An Exploratory Study of Quantitative [18F]FLT-PET and Advanced MRI as Early Indicators of Treatment Response and Molecular Markers for Cell Proliferation in Patients With Glioblastoma Following Subtotal Resection

Important dates

Study start
2008
Primary completion
2010
Study completion
2012
First posted
Jun 18, 2013
Registry last updated
Jun 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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