MedTrace Logo

Prognostic Evaluation of 18fmiso Pet-ct in Head and Neck Cancer

NCT01235052 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-05-14

No results posted yet for this study

Summary

Head and neck cancer is the sixth most frequent cancer worldwide, excluding lymphomas and skin cancer. If 18FDG PET is considered today as a standard tool in patients with head and neck squamous cell carcinoma (HNSCC) not only for tumoral or nodal staging but also for assessment of distant metastases and synchronous second primary malignancies, hypoxia is one of the most important prognostic factors in radiotherapy of this type of tumors. The only gold standard method for direct determination of oxygen tension is based on using oxygen electrodes showing a good relation with clinical outcome but complex in its realisation. So, PET using 18F-FMISO has been described to be useful for the non invasive assessment of hypoxia in cancer. Especially in France, the use of this radiotracer is very limited and there is no standardised methodology to acquire and quantify 18F-FMISO signal. So there is a need for a rigorous evaluation of this PET tracer. In another way, it could be a very useful tool for evaluation of new therapies and modification of volumes in radiotherapy.

Conditions

  • Cancer of Head and Neck
  • Head and Neck Neoplasms

Interventions

RADIATION

Positon Emission Tomography using 18F-FMISO

We will introduce a pretherapy \[18F\]-FMISO PET-CT in the treatment planning of patients suffering of head and neck cancer and eligible to a radical treatment with curative intent, consisting of conformational radiotherapy with or without chemotherapy or associated targeted therapy. \[18F\]-FMISO PET-CT results will not be taken into account for the patients' management. We will test different acquisition protocols and use a wild panel of quantification parameters issued from published studies and originals 'one developed by our team enable to describe \[18F\]-FMISO uptake. Patients will be followed clinically and para-clinically during two years after the end of the treatment according to the edited recommendations of these tumours type and grade to analyze outcome.

Sponsors & Collaborators

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • CLERMONT-GALLERANDE Henri, MCU-PH · University Hospital, Bordeaux

  • PEREZ Paul, PH · University Hospital, Bordeaux

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01235052 on ClinicalTrials.gov