Diagnostic Performance of 18F-FDG-PET and Diffusion-weighted MRI in the Assessment of Stage IB to IIB2 Cervical Squamous-cell Carcinoma Response to Concomitant Radiochemotherapy and Brachytherapy
Conditions
Squamous-cell Cervical Carcinoma Stage IB2 to IIB Without Spread to Lymph Nodes or Metastasis
Conditions: official terms
Carcinoma - Carcinoma, Squamous Cell - Uterine Cervical Neoplasms
Conditions: Keywords
2-fluoro-2-deoxy-d-glucose-positron emission tomography, Positron emission tomography, Magnetic resonance imaging, Diffusion weighted MRI, Squamous-cell cervical carcinoma, Sensitivity
Study Type
Interventional
Study Phase
N/A
Study Design
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: 18F-FDG-PET
Type: Device
Overall Status
Recruiting
Summary
Rationale: The benefit-risk ratio of surgery following concomitant radiochemotherapy and brachytherapy remains to be defined in cervical squamous-cell carcinoma (SCC) treatment. Scarce studies evaluated the interest of 18F-FDG-PET and MRI in the assessment of response to treatment before surgery. A positive predictive value of 75% was found in a small study making 18F-FDG-PET a promising tool to assess tumor response and guide surgical approach. Diffusion-weighted MRI was also described as an early and sensitive indicator in other diseases.

Objectives: The main objective of this study is to evaluate the sensitivity of 18F-FDG-PET in the assessment of cervical cancer response to radiochemotherapy and brachytherapy. Secondary objectives focus on 18F-FDG-PET specificity and likehood ratios as well as diffusion-weighted MRI diagnostic performances.

Method: We will conduct a prospective cohort study of 148 women with a stage IB to IIB2 cervical SCC recruited over 2.5 years in 11 centers in France. Each patient will undergo a 18F-FDG-PET and a diffusion-weighted MRI before surgery and 8 weeks after completion of the brachytherapy. The total follow-up duration (study participation) of patients will be 11 weeks : inclusion after completion of radiochemotherapy and brachytherapy, 8 weeks until 18F-FDG-PET and diffusion-weighted MRI, and 3 weeks until surgery.

Expected results: 18F-FDG-PET and diffusion-weighted MRI could constitute a reliable tool to assess response to radiochemotherapy and brachytherapy in cervical SCC treatment. If so it could improve clinical practices and be helpful to decide whether the patient needs surgery or not after radiochemotherapy and brachytherapy.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

- Female patients 18 years of age or older

- Biopsy-confirmed cervical squamous-cell carcinomas

- Stage IB2, IIA ou IIB according to the FIGO staging of cervical carcinomas

- No spread to lumbo-aortic lymph nodes

- No prior pelvic radiotherapy

- No prior cancer treatment

- WHO Performance status less than or equal to 1

- Beneficiary of a health insurance

- Must provide her signed and informed consent

Exclusion Criteria:

- Reccurent or Metastasized cancer

- History of uncontrolled cancer, or any cancer treated for less than 5 years (except basal cell carcinomas)

- Any contraindication to MRI

- Know hypersensitivity to Gadolinium, 18F-FDG or one of the excipients

- Pregnant or breast feeding patients

- Participation in any other clinical trial that could interfere with the study results

- Any geographical, social or psychical reasons that could prohibit the ability to return for follow-up assessment
Locations
Service de Médecine Nucléaire, Institut de cancérologie de l'Ouest - Site Paul Papin
Angers, France
Status: Recruiting
Contact: Sylvie GIRAULT, MD
Service Gynécologie Obstétrique, Hôpital Pellegrin, CHU Bordeaux
Bordeaux, France
Status: Recruiting
Contact: Jean-Luc BRUN, MD, PhD
Service de Gynécologie, Hôpital Femme Mère Enfant, Hospices Civils de Lyon
Bron, France
Status: Recruiting
Contact: Gery LAMBLIN, MD, PhD
Service de Chirurgie Oncologique, Centre de Lutte Contre le Cancer Georges-François Leclerc
Dijon, France
Status: Recruiting
Contact: Charles COUTANT, MD
Service de Gynécologie Obstétrique, Hôpital de la Croix-Rousse, Hospices Civils de Lyon
Lyon, France
Status: Recruiting
Contact: Gil DUBERNARD, MD, PhD
Service de Gynécologie Obstétrique, Hôpital Nord
Marseille, France
Status: Recruiting
Contact: Léon BOUBLI, MD
Service de Chirurgie Gynécologique, Hôpital Arnaud de Villeneuve
Montpellier, France
Status: Recruiting
Contact: Gauthier RATHAT, MD
Service de Radiothérapie, C.R.L.C. Val d'Aurelle
Montpellier, France
Status: Recruiting
Contact: Christine KERR, MD
Service de Gynécologie, Hôpital Archet II
Nice, France
Status: Recruiting
Contact: Jérôme DELOTTE, MD
Service de Chirurgie Gynécologique, Institut Curie
Paris, France
Status: Recruiting
Contact: Virginie FOURCHOTTE, MD
Service de Gynécologie Obstétrique, Hôpital Tenon, APHP
Paris, France
Status: Recruiting
Contact: Emile DARAI, MD, PhD
Service de Gynécologie, Hôpital Européen Georges Pompidou, APHP
Paris, France
Status: Recruiting
Contact: Fabrice LECURU, MD, PhD
Service de Gynécologie Obstétrique, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
Pierre-Bénite, France
Status: Recruiting
Contact: François GOLFIER, MD, PhD - 478 86 41 79 - francois.golfier@chu-lyon.fr
Service de Gynécologie Obstétrique, CHU la Milétrie
Poitiers, France
Status: Recruiting
Contact: Xavier FRITEL, MD
Département des Radiations, Centre Eugène Marquis
Rennes, France
Status: Recruiting
Contact: Julie LESEUR, MD
Service de Gynécologie Obstétrique, CHU Anne de Bretagne Hôpital Sud
Rennes, France
Status: Recruiting
Contact: Jean LEVEQUE, MD, PhD
Service de Chirurgie, Centre Henri Becquerel
Rouen, France
Status: Recruiting
Contact: Frédérique FORESTIER-LEBRETON, MD
Service de Chirurgie Gynécologique, Institut Curie - Hôpital René Huguenin
Saint-Cloud, France
Status: Recruiting
Contact: Roman ROUZIER, MD
Service de Gynécologie Obstétrique, CHU St-Etienne
Saint-Etienne, France
Status: Recruiting
Contact: Céline CHAULEUR, MD
Servce de Médecine Nucléaire, Centre René Gauducheau, CRLCC Nantes Atlantique
Saint-Herblain, France
Status: Recruiting
Contact: Caroline ROUSSEAU, MD, PhD
Département de Radiothérapie, Institut de Cancérologie de la Loire
Saint-Priest en Jarez, France
Status: Recruiting
Contact: Nicolas MAGNE, MD
Service de Chirurgie Oncologique, Institut de Cancérologie de Lorraine
Vandoeuvre lès Nancy, France
Status: Recruiting
Contact: Frédéric MARCHAL, MD
Service de Médecine Nucléaire, Hôpital Brabois
Vandoeuvre-lès-Nancy, France
Status: Recruiting
Contact: Pierre OLIVIER, MD
Start Date
January 2012
Completion Date
May 2016
Sponsors
Hospices Civils de Lyon
Source
Hospices Civils de Lyon
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page