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Hypoxia Diagnosis and Evaluation Using F-MISO PET and Biomarkers in Brain Tumors


Phase 2
18 Years
N/A
Not Enrolling
Both
Anaplastic Glioma

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Trial Information

Hypoxia Diagnosis and Evaluation Using F-MISO PET and Biomarkers in Brain Tumors


Inclusion Criteria:



- adults aged >= 18 years

- KPS >= 70%

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

- 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 >= 100,000 cells/µl, SGOT <= 2.5 x ULN, serum creatinine <= 1.5 x ULN

Exclusion Criteria:

- contraindication to surgery

- concomitant radio-, chemo-, or immunotherapy

- known diagnosis of Human Immunodeficiency Virus (HIV) infection

- patient with hepatitis B or C

- diabetic patient

- patient with kidney or liver deficiency

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

hypoxia volume (HV) and degree (maximum ratio [Rmax]) defined from 18F-FMISO uptake rates

Outcome Description:

determine, in vivo, the hypoxic character of tumours from a PET biomarker. Tumoral hypoxia will be characterized by hypoxia volume (HV) and degree (maximum ratio [Rmax]) defined from 18F-FMISO uptake rates characterize the link between the tumoral hypoxia and the hypoxic and angiogenic factor expressions that favour vascular neoformation and proliferation feeding tumoral cells

Outcome Time Frame:

PET 18F-MISO between Day 1 & Day 7

Safety Issue:

No

Principal Investigator

GUILLAMO Jean Sébastien, 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:

2009-015543-16

NCT ID:

NCT01200134

Start Date:

October 2010

Completion Date:

July 2012

Related Keywords:

  • Anaplastic Glioma
  • glioma patients : anaplasic glioma (grade III) and GBM (grade IV)
  • Brain Neoplasms
  • Glioma
  • Anoxia

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