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

Primary Purpose

Cervical Cancer

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
PET
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cervical Cancer focused on measuring PETscan, cervical cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Gynécologie ObstétriqueRecruiting
  • Médecine NucléaireRecruiting
  • Oncologie MédicaleRecruiting

Outcomes

Primary Outcome Measures

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

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.

Full Information

First Posted
September 14, 2005
Last Updated
January 31, 2006
Sponsor
University Hospital, Limoges
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1. Study Identification

Unique Protocol Identification Number
NCT00199680
Brief Title
Interest of PET Imagery With 18-FDG in the Extension Assessment of the Cervical Cancer
Official Title
Interest of PET Imagery With 18-FDG in the Extension Assessment of the Cervical Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
October 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Limoges

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
PETscan, cervical cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (false)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dominique GENET, MD
Phone
+33(0) 555 056 396
Email
dominique.genet@chu-limoges.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique GENET, MD
Organizational Affiliation
University Hospital, Limoges
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gynécologie Obstétrique
City
Limoges
ZIP/Postal Code
87000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yves AUBARD, MD
First Name & Middle Initial & Last Name & Degree
Yves AUBARD, MD
Facility Name
Médecine Nucléaire
City
Limoges
ZIP/Postal Code
87000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques MONTEIL, MD
First Name & Middle Initial & Last Name & Degree
Jacques MONTEIL, MD
Facility Name
Oncologie Médicale
City
Limoges
ZIP/Postal Code
87000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique GENET, MD
First Name & Middle Initial & Last Name & Degree
Dominique GENET, MD
First Name & Middle Initial & Last Name & Degree
Nicole TUBIANA-MATHIEU, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
22110211
Citation
Monteil J, Maubon A, Leobon S, Roux S, Marin B, Renaudie J, Genet D, Fermeaux V, Aubard Y, Tubiana-Mathieu N. Lymph node assessment with (18)F-FDG-PET and MRI in uterine cervical cancer. Anticancer Res. 2011 Nov;31(11):3865-71.
Results Reference
derived

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

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