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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


N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

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


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

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

Performance of FDG-PET for the evaluation of nodal status

Outcome Description:

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.

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

SWITSERS Odile, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre François Baclesse

Authority:

France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

Study ID:

TEP-Sein

NCT ID:

NCT01436591

Start Date:

March 2009

Completion Date:

August 2012

Related Keywords:

  • Breast Cancer
  • Cancer
  • Breast
  • 18FDG
  • Axillary
  • Positron Emission Tomography
  • Breast Neoplasms

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