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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


N/A
18 Years
N/A
Not Enrolling
Both
Glioblastoma

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Trial Information

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


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

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

Outcome Description:

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

Outcome Time Frame:

Before and after chemotherapy/radiation therapy

Safety Issue:

No

Principal Investigator

Delphine L Chen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

08-0073

NCT ID:

NCT01880008

Start Date:

April 2008

Completion Date:

August 2012

Related Keywords:

  • Glioblastoma
  • positron emission tomography
  • magnetic resonance imaging
  • diffusion magnetic resonance imaging
  • radionuclide imaging
  • disease management
  • radiation therapy
  • Glioblastoma

Name

Location

Washington University School of Medicine/Barnes-Jewish Hospital St. Louis, Missouri  63110