Interest of PET Imagery With 18-FDG in the Extension Assessment of the Cervical Cancer

January 31, 2006 updated by: University Hospital, Limoges

In cervical cancer prognosis factors are size of the tumour, pelvic and para-aortic lymph nodes involvement. The initial treatment taking is determined by lymph node evaluation.

Early stage cervical cancers at their very beginning, with no lymph node involvement, will be treated either by surgery only or by radiotherapy only, or by both at the same time. At advanced stages, from proximal IB to IIB with bad prognosis (tumour larger than 4 cm and pelvic lymph node involvement), as well as for cancers up to distal stages IIB, III and IVA, treatment relies on radio-chemotherapy, either alone or pre-surgery.

The pre-therapeutic complete examination of the cervical cancer includes a clinical examination and a pelvic MRI in order to look for pelvic and para-aortic lymph nodes and to precise the volume and the spreading of the tumour in the pelvic area.

A meta-analysis estimating the interest of the MRI showed a variable sensitivity and a specificity for the detection of such lymph node metastasis with a sensitivity varying from 24 to 75 % and a specificity between 84 and 100 % according to the studies.

As for the use of an 18-FDG PET scan to detect lymph node involvement, the studies realized so far are performed, usually, on a small number of subjects and with heterogeneous populations. However, it seems that such an examination enables a better detection of lymph nodes than the MRI does, especially for para-aortic lymph nodes depending on the studies, sensitivity varies from 57 to 100 %, and specificity between 92 and 100 %.

We propose a prospective, multicentric and multidisciplinary study for the estimation of diagnosis methods. The main aim is to estimate the interest of the 18-FDG PET scan for the detection of pelvic and para-aortic lymph node metastasis in patients with cervical cancer, in comparison with the MRI. This study should enable to include 380 patients within 3 years. An 18-FDG scintigraphy will be performed before any treatment together with an MRI. A comparison between the sensitivity and the specificity of both examinations will be established and a correlation with the histology of the lymph node dissection will be made.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

42

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Limoges, France, 87000
        • Recruiting
        • Gynécologie Obstétrique
        • Contact:
          • Yves AUBARD, MD
      • Limoges, France, 87000
        • Recruiting
        • Médecine Nucléaire
        • Contact:
          • Jacques MONTEIL, MD
        • Sub-Investigator:
          • Jacques MONTEIL, MD
      • Limoges, France, 87000
        • Recruiting
        • Oncologie Médicale
        • Contact:
          • Dominique GENET, MD
        • Principal Investigator:
          • Dominique GENET, MD
        • Sub-Investigator:
          • Nicole TUBIANA-MATHIEU, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patient with cervical carcinoma: histological proof of epidermoid carcinoma or of adenocarcinoma
  • Stage I to IV (limited to pelvic) (FIGO Classification) (see appendix 3)
  • Age ≥ 18 years old
  • No contra-indication to surgery
  • Dated, informed and signed consent from the patient

Exclusion Criteria:

  • Metastatic cervical cancer with extra-pelvic metastasis
  • Contra-indication to MRI: implantation of an electronic device, metallic or ferromagnetic foreign body
  • Serious co-existing affection with vital prognosis
  • Diabetes uncontrolled by a classical treatment: glycaemia > 1.4g/l
  • Pregnancy and lactation
  • Uncontrolled infection
  • Other cancer within the previous 5 years, except skin basal cell carcinoma, or in situ cervical cancer
  • Patient with some deficiency preventing her from completely understanding any requirement of the study, which might compromise the patient's consent and/or the observance of the protocol and the consistent participation to the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Estimation of the pelvic and/or para-aortic lymph node involvement with the PET, in comparison with the MRI and the histological results of node dissection.

Secondary Outcome Measures

Outcome Measure
Before initial treatment
- Evaluation of the size and local spreading of the tumour with MRI.
- Evaluation of tumour fixation with PET (including SUV quantifying).
- Comparison between both imaging methods.
Post radio-chemotherapy evaluation
- Evaluation of residual tumour and/or lymph nodes by MRI in comparison with initial size.
- Evaluation of residual tumour and/or lymph node by PET with SUV quantifying and in comparison with the initial value.
- Correlation between the results obtained with imaging and the histology of the surgical resection.
Study of disease free survival.
- In advanced stages: according to pelvic and/or extra-pelvic hyperfixation with the initial PET (SUV quantifying)
- According to staging obtained by MRI.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Limoges

Investigators

  • Principal Investigator: Dominique GENET, MD, University Hospital, Limoges

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

February 1, 2006

Last Update Submitted That Met QC Criteria

January 31, 2006

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I03017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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