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

NCT01235052 | Completed DMC

• 2 other identifiers: CHUBX 2008/202008-006411-20
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Head and neck neoplasms; Positron Emission Tomography; F18 fluoromisonidazole

Outcome Measures

Primary Outcomes (1)

• Correlation between a hypoxic volume determined by [18F]-FMISO PET-CT and a treatment response two years after radical treatment.

  Inclusion (Day 0) and after two years

Secondary Outcomes (2)

• Evaluate the potential role of a new biological tumour volume (BTV) taking account hypoxia for the delineation of volumes for radiotherapy treatment planning

  Inclusion (Day 0)

• Study pathological processes contributing to [18F]-FMISO uptake by the correlation with other parameters considered to be representative of hypoxia in tumours

  After two years

Study Arms (1)

TEP with 18F-FMISO

EXPERIMENTAL

TEP with 18F-FMISO

Radiation: Positon Emission Tomography using 18F-FMISO

Interventions

Positon Emission Tomography using 18F-FMISO RADIATION

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.

TEP with 18F-FMISO

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 presenting a squamous cell head and neck carcinoma proposed for a radical treatment consisting in conformational radiotherapy with or without chemotherapy or associated targeted therapy
• Signed informed consent

You may not qualify if:

• Patients suffering of a second cancer or treated before by radiotherapy in the tumour site.
• Pregnancy

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (2)

CHU de Bordeaux - Hôpital Pellegrin

Bordeaux, 33 076, France

Location

Hôpital Robert Picqué

Villenave-d'Ornon, 33882, France

Location

Related Publications (2)

• Henriques de Figueiredo B, Zacharatou C, Galland-Girodet S, Benech J, De Clermont-Gallerande H, Lamare F, Hatt M, Digue L, De Mones del Pujol E, Fernandez P. Hypoxia imaging with [18F]-FMISO-PET for guided dose escalation with intensity-modulated radiotherapy in head-and-neck cancers. Strahlenther Onkol. 2015 Mar;191(3):217-24. doi: 10.1007/s00066-014-0752-8. Epub 2014 Sep 23.

  PMID: 25245468 RESULT

• Henriques de Figueiredo B, Merlin T, de Clermont-Gallerande H, Hatt M, Vimont D, Fernandez P, Lamare F. Potential of [18F]-fluoromisonidazole positron-emission tomography for radiotherapy planning in head and neck squamous cell carcinomas. Strahlenther Onkol. 2013 Dec;189(12):1015-9. doi: 10.1007/s00066-013-0454-7. Epub 2013 Nov 1.

  PMID: 24173497 RESULT

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• CLERMONT-GALLERANDE Henri, MCU-PH

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• PEREZ Paul, PH

  University Hospital, Bordeaux

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2009
• First Posted: November 5, 2010
• Study Start: June 1, 2009
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: May 14, 2026

Record last verified: 2014-08

Locations

FR (2)