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Trial record 1 of 75 for:    Washington University | GBM
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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

Tracking Information
First Submitted Date July 30, 2010
First Posted Date June 18, 2013
Last Update Posted Date June 18, 2013
Study Start Date April 2008
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 13, 2013)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 13, 2013)
  • Survival [ Time Frame: 2 years ]
    Number of months from date of diagnosis to date of death.
  • Ki-67 [ Time Frame: At diagnosis ]
    Ki-67 proliferation index on tumor specimens obtained at biopsy or from surgical resection specimen
  • 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
  • O(6)-methylguanine DNA-methyltransferase (MGMT) activity [ Time Frame: prior to treatment ]
    MGMT activity from tumor specimens
  • Time to progression [ Time Frame: 2 years ]
    Months after completing radiation treatment to first instance of radiographic progression
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of FLT PET and MRI as Imaging Biomarkers of Early Treatment Response in Patients With Glioblastoma
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
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.
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with WHO grade III or IV glioma
Condition Glioblastoma
Intervention Not Provided
Study Groups/Cohorts Treatment
All patients included in this study were treated with temozolomide and radiotherapy after subtotal resection of a WHO grade III or IV glioma.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 13, 2013)
5
Original Actual Enrollment Same as current
Actual Study Completion Date August 2012
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01880008
Other Study ID Numbers 08-0073
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Delphine L. Chen, MD, Washington University School of Medicine
Study Sponsor Washington University School of Medicine
Collaborators Barnes-Jewish Hospital
Investigators
Principal Investigator: Delphine L Chen, MD Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date June 2013