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

NCT01663753 | Completed

• 1 other identifier: 2011.670/13
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 24

Brief 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 24 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.

Conditions

Cancer of the Uterine Cervix

Keywords

2-fluoro-2-deoxy-d-glucose-positron emission tomography; Positron emission tomography; Magnetic resonance imaging; Diffusion weighted MRI; Squamous-cell cervical carcinoma; Sensitivity

Outcome Measures

Primary Outcomes (1)

• Sensitivity of 18F-FDG-PET in the assessment of stage IB to IIB2 cervical squamous-cell carcinoma response to concomitant radiochemotherapy and brachytherapy

  A centralized review will be carried out by 2 independant reviewers, additionally to the initial interpretation. The gold-standard to evaluate tumoral response to radiochemotherapy and brachytherapy will be the anatomopathologic analysis of the hysterectomy piece after surgery. The18F-FDG-PET will be performed 8 weeks following completion of brachytherapy (date of inclusion)and surgery will be performed within 3 weeks after the 18F-FDG-PET.

  8 weeks

Secondary Outcomes (2)

• Specificity and likehood ratios of 18F-FDG-PET in the assessment of stage IB to IIB2 cervical squamous-cell carcinoma response to concomitant radiochemotherapy and brachytherapy

  8 weeks

• Diagnostic performances of diffusion-wheighed MRI in the assessment of stage IB to IIB2 cervical squamous-cell carcinoma response to concomitant radiochemotherapy and brachytherapy

  8 weeks

Study Arms (1)

18F-FDG-PET

EXPERIMENTAL

The 18F-FDG-PET will be performed 8 weeks following completion of brachytherapy (date of inclusion)

Device: 18F-FDG-PET

Interventions

18F-FDG-PET DEVICE

18F-FDG-PET

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (24)

Service de Médecine Nucléaire, Institut de cancérologie de l'Ouest - Site Paul Papin

Angers, 49933, France

Location

Service Gynécologie Obstétrique, Hôpital Pellegrin, CHU Bordeaux

Bordeaux, 33076, France

Location

Service de Gynécologie, Hôpital Femme Mère Enfant, Hospices Civils de Lyon

Bron, 69677, France

Location

Service de Chirurgie Oncologique, Centre de Lutte Contre le Cancer Georges-François Leclerc

Dijon, 21079, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Service de Gynécologie Obstétrique, Hôpital de la Croix-Rousse, Hospices Civils de Lyon

Lyon, 69004, France

Location

Service de Gynécologie Obstétrique, Hôpital Nord

Marseille, 13915, France

Location

Service de Chirurgie Gynécologique, Hôpital Arnaud de Villeneuve

Montpellier, 34295, France

Location

Service de Radiothérapie, C.R.L.C. Val d'Aurelle

Montpellier, 34298, France

Location

Service de Gynécologie, Hôpital Archet II

Nice, 06200, France

Location

Service de Gynécologie, Hôpital Européen Georges Pompidou, APHP

Paris, 75015, France

Location

Service de Gynécologie Obstétrique, Hôpital Tenon, APHP

Paris, 75020, France

Location

Service de Chirurgie Gynécologique, Institut Curie

Paris, 75248, France

Location

Service de Gynécologie Obstétrique, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon

Pierre-Bénite, 69310, France

Location

Service de Gynécologie Obstétrique, CHU la Milétrie

Poitiers, 86021, France

Location

Service de Gynécologie Obstétrique, CHU Anne de Bretagne Hôpital Sud

Rennes, 35000, France

Location

Département des Radiations, Centre Eugène Marquis

Rennes, 35042, France

Location

Service de Chirurgie, Centre Henri Becquerel

Rouen, 76038, France

Location

Service de Chirurgie Gynécologique, Institut Curie - Hôpital René Huguenin

Saint-Cloud, 92210, France

Location

Service de Gynécologie Obstétrique, CHU St-Etienne

Saint-Etienne, 42055, France

Location

Servce de Médecine Nucléaire, Centre René Gauducheau, CRLCC Nantes Atlantique

Saint-Herblain, 44805, France

Location

Département de Radiothérapie, Institut de Cancérologie de la Loire

Saint-Priest-en-Jarez, 42271, France

Location

Service de Médecine Nucléaire, Hôpital Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Service de Chirurgie Oncologique, Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Hypersensitivity

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Immune System Diseases

Study Officials

• GOLFIER François, MD, PhD

  Centre Hospitalier Lyon Sud, Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 9, 2012
• First Posted: August 13, 2012
• Study Start: March 1, 2012
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: January 7, 2019

Record last verified: 2019-01

Locations

FR (24)