Informations générales (source: ClinicalTrials.gov)
Interest of PET Imagery With 18-FDG in the Extension Assessment of the Cervical Cancer
Interventional
Phase 2
University Hospital, Limoges (Voir sur ClinicalTrials)
octobre 2003
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Médecine Nucléaire - 87000 - Limoges - France | Jacques MONTEIL, MD | Contact (sur clinicalTrials) | |||
| Oncologie Médicale - 87000 - Limoges - France | Dominique GENET, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Gynécologie Obstétrique - 87000 - Limoges - France | Yves AUBARD, MD | Contact (sur clinicalTrials) | |||
Critères
Femme
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
- 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
- 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.