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Comparison of Diagnostic Performance of an Algorithm and a High Definition Classical Iterative Algorithm Positron Emission Tomography (PET) to 18Fluoro-deoxy-glucose (18FDG) in the Evaluation of Axillary Lymph Node Invasion of Breast Tumors (TEP-Sein)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Centre Francois Baclesse
ClinicalTrials.gov Identifier:
NCT01436591
First received: September 15, 2011
Last updated: September 7, 2012
Last verified: September 2012
History of Changes
  Purpose

The primary endpoint of this study is to show that this algorithm in high definition is superior to the classical algorithm in the diagnosis of lymph node metastases.


Condition
Breast Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Comparison of Diagnostic Performance of an Algorithm and a High Definition Classical Iterative Algorithm Positron Emission Tomography (PET) to 18Fluoro-deoxy-glucose (18FDG) in the Evaluation of Axillary Lymph Node Invasion of Breast Tumors

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre Francois Baclesse:

Primary Outcome Measures:
  • Performance of FDG-PET for the evaluation of nodal status [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Show that the algorithm of high-definition positron emission tomography (PET) to 18Fluoro-deoxy-glucose (18FDG) is greater than a classical algorithm in the diagnosis of lymph node metastases.


Secondary Outcome Measures:
  • Information on lymph node status in patients with breast cancer. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Show that scintigraphy performed on a FDG positron camera equipped with a reconstruction algorithm for high-definition can provide reliable information on lymph node status in patients with breast cancer and determine the minimum size of lymph node metastatic lesions.


Enrollment: 63
Study Start Date: March 2009
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Preoperative assessment of breast cancer.

Criteria

Inclusion Criteria:

  • Informed consent and signed by the patient
  • Age ≥ 18 years
  • Breast tumor for which the therapeutic indication for surgery has from the outset: breast surgery (conservative or radical) associated with a conventional axillary dissection
  • Proof of infiltrating ductal carcinoma histology
  • No known metastasis
  • No cons-indication to anesthesia.

Exclusion criteria:

  • History of neoadjuvant therapy
  • Patients with invasive lobular carcinoma
  • Indication of the use of sentinel node (if invasive carcinoma uni-centric, ≤ 2 cm in diameter, without palpable lymphadenopathy (N0))
  • Diabetes is not controlled by conventional treatment (blood glucose> 1.8 g / l)
  • Inability to capital
  • Patients who are pregnant or nursing or of childbearing potential and not using adequate contraception
  • Persons deprived of their liberty
  • Major subject of a measure of legal protection or unable to consent
  • Refusal to participate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01436591

Locations
France
Centre François Baclesse
Caen, France, 14076
Sponsors and Collaborators
Centre Francois Baclesse
Investigators
Principal Investigator: SWITSERS Odile, Dr Centre François Baclesse
  More Information

No publications provided

Responsible Party: Centre Francois Baclesse
ClinicalTrials.gov Identifier: NCT01436591     History of Changes
Other Study ID Numbers: TEP-Sein
Study First Received: September 15, 2011
Last Updated: September 7, 2012
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

Keywords provided by Centre Francois Baclesse:
Cancer
Breast
18FDG
Axillary
Positron Emission Tomography

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Deoxyglucose
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013