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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


N/A
18 Years
N/A
Open (Enrolling)
Female
Squamous-cell Cervical Carcinoma Stage IB2 to IIB Without Spread to Lymph Nodes or Metastasis

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

8 weeks

Safety Issue:

No

Principal Investigator

GOLFIER François, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Hospitalier Lyon Sud, Hospices Civils de Lyon

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

2011.670/13

NCT ID:

NCT01663753

Start Date:

January 2012

Completion Date:

November 2014

Related Keywords:

  • Squamous-cell Cervical Carcinoma Stage IB2 to IIB Without Spread to Lymph Nodes or Metastasis
  • 2-fluoro-2-deoxy-d-glucose-positron emission tomography
  • Positron emission tomography
  • Magnetic resonance imaging
  • Diffusion weighted MRI
  • Squamous-cell cervical carcinoma
  • Sensitivity
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Neoplasm Metastasis
  • Uterine Cervical Neoplasms

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