Evaluation of [18F]-FMISO for Non Operated Glioblastoma

NCT00906893 | Completed Phase 2

• 1 other identifier: CHUBX2008/31
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Hypoxia is recognized to be an independent predictor of clinical outcome in oncology. PET using \[18F\]-FMISO has been described to be useful for the non invasive assessment of hypoxia in cancer. The use of this radiotracer for brain tumours is very limited and there is no standard to acquire and quantify \[18F\]-FMISO uptake. So there is a need for a methodological evaluation of this PET tracer The purpose of this research is to define optimal parameters for acquisition and data exploitation to quantify \[18F\]-FMISO uptake and so predict clinical outcome in glioblastomas. Low sensitivity to radiation of glioblastoma is partly caused by hypoxia. Hypoxia in tumours is not predicted by tumour size. Detecting and monitoring tissue oxygenation are of great interest to modify therapeutic strategies, including local dose escalation for radiotherapy or select chemotherapeutic agents with better impact in glioblastomas. PET with appropriate radiotracers, especially \[18F\]-FMISO, enables non-invasive assessment of hypoxia. \[18F\]-FMISO only accumulates in viable hypoxic cells. So, it has been demonstrated that PET using 18F-FMISO is suitable to localize and quantify hypoxia. But there isn't any optimal acquisition protocol or standardized images quantification treatment. Thus, the interpretation of \[18F\]-FMISO PET images and the predictive value of \[18F\]-FMISO SUV (Standardized Uptake Value) remain unclear explaining the need of methodological approaches.

Conditions

Glioblastoma

Keywords

[18F]-FMISO uptake; Glioblastoma; Hypoxia; tumours

Outcome Measures

Primary Outcomes (1)

• determine acquisition protocol and robust quantification parameters representative of tumour hypoxia using [18F]-FMISO PET-CT in glioblastomas

  day 1

Secondary Outcomes (3)

• prognostic value of [18F]-FMISO PET-CT in glioblastomas treated by conformational radiotherapy and/or chemotherapy

  after one year

• Evaluate the potential role of a new biological tumour volume (BTV) taking into account hypoxia for the delineation of radiotherapy treatment planning when patients undergone this treatment

  after the end of the study

• Study of pathological processes contributing to [18F]-FMISO uptake such as: microvessel density and endogenous markers (Hypoxia Inducible Factor (HIF1), Carbonic Anhydrase isoenzyme IX (CAIX), Lysyl Oxidase (LOX), p53) determined on biopsy tissues.

  after the end of study

Study Arms (1)

1

EXPERIMENTAL

Procedure: 18F]-FMISO PET-CT

Interventions

18F]-FMISO PET-CT PROCEDURE

pretherapy(\[18F\]-FMISO) positon emission tomography-computed tomography. Different acquisition protocols will be tested and a wild panel of quantification parameters issued from published studies and original ones developed by our team enable to describe \[18F\]-FMISO uptake will be used.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18
• Patients with a malignant tumour glioblastomas proposed for a radical treatment consisting in conformational radiotherapy and/or chemotherapy
• Signed informed consent

You may not qualify if:

• Patients who can't undergo radiotherapy or chemotherapy
• Patients suffering of a second cancer or treated before by radiotherapy in the tumour site.
• Pregnant and breast feeding women, women in age to procreate without contraception

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux - Hôpital Pellegrin

Bordeaux, 33076, France

Location

Related Publications (1)

• Huchet A, Fernandez P, Allard M, Belkacemi Y, Maire JP, Trouette R, Eimer S, Tourdias T, Loiseau H. [Molecular imaging of tumor hypoxia]. Cancer Radiother. 2009 Dec;13(8):747-57. doi: 10.1016/j.canrad.2009.07.038. Epub 2009 Oct 23. French.

  PMID: 19854090 RESULT

MeSH Terms

Conditions

Glioblastoma; Hypoxia; Neoplasms

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aymeri HUCHET, PHU

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2009
• First Posted: May 21, 2009
• Study Start: June 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2013
• Last Updated: May 14, 2026

Record last verified: 2013-02

Locations

FR (1)