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Assessment of [18F]FLT-PET Imaging for Diagnosis and Prognosis of Brain Tumors


N/A
18 Years
N/A
Not Enrolling
Both
Cancer, Brain Tumors

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Trial Information

Assessment of [18F]FLT-PET Imaging for Diagnosis and Prognosis of Brain Tumors


Inclusion Criteria:



- adults aged between 18 and 70 years

- must have operable grade II, III or IV glioma, recurrent high grade glioma or brain
metastases

- KPS >= 70%

- must have the understanding and ability to sign an informed consent document

- must have adequate liver and kidney function

- be male or non-pregnant, non-lactating females

- patients who are fertile must agree to use an effective method of contraception
during participation in the study

- the following laboratory results : absolute neutrophil count >= 1500 cells/µl,
platelet count >= 100000 cells/µl, SGOT <= 2.5 x ULN, serum creatinine <= 1.5 x ULN.

Exclusion Criteria:

- contraindication to surgery

- concomitant radio-, chemo-, or immunotherapy

- history of significant dementia

- known diagnosis of Human Immunodeficiency Virus (HIV) infection

- patient with hepatitis B or C

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

To evaluated the aggressive potential of brain tumors related to cell proliferation index measured by [18F]FLT

Outcome Time Frame:

Day 10

Safety Issue:

No

Principal Investigator

Jean-Sébastien Guillamo, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Caen

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

2007-006265-32

NCT ID:

NCT00850278

Start Date:

October 2008

Completion Date:

July 2011

Related Keywords:

  • Cancer
  • Brain Tumors
  • Brain tumor
  • [18F]FLT
  • [11C]MET
  • TEP-imaging
  • tumor cell proliferation
  • Brain Neoplasms

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