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

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ClinicalTrials.gov Identifier: NCT01880008
Recruitment Status : Completed
First Posted : June 18, 2013
Last Update Posted : June 18, 2013
Sponsor:
Collaborator:
Barnes-Jewish Hospital
Information provided by (Responsible Party):
Delphine L. Chen, MD, Washington University School of Medicine

Brief Summary:
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.

Condition or disease
Glioblastoma

Detailed Description:
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.

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Study Type : Observational
Actual Enrollment : 5 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official 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
Study Start Date : April 2008
Actual Primary Completion Date : February 2010
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine


Group/Cohort
Treatment
All patients included in this study were treated with temozolomide and radiotherapy after subtotal resection of a WHO grade III or IV glioma.



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with WHO grade III or IV glioma
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01880008


Locations
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United States, Missouri
Washington University School of Medicine/Barnes-Jewish Hospital
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Barnes-Jewish Hospital
Investigators
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Principal Investigator: Delphine L Chen, MD Washington University School of Medicine

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Responsible Party: Delphine L. Chen, MD, Assistant Professor of Radiology, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01880008     History of Changes
Other Study ID Numbers: 08-0073
First Posted: June 18, 2013    Key Record Dates
Last Update Posted: June 18, 2013
Last Verified: June 2013
Keywords provided by Delphine L. Chen, MD, Washington University School of Medicine:
positron emission tomography
magnetic resonance imaging
diffusion magnetic resonance imaging
radionuclide imaging
disease management
radiation therapy
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue