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

Breast Cancer Clinical Trial

— TEP-Sein  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01436591
• Other study ID #: TEP-Sein
• Status: Terminated
• Phase: N/A
• First received: September 15, 2011
• Last updated: September 7, 2012
• Start date: March 2009
• Est. completion date: August 2012

Study information

• Verified date: September 2012
• Source: Centre Francois Baclesse
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 63
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer

Locations

Country	Name	City	State
France	Centre François Baclesse	Caen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Francois Baclesse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance of FDG-PET for the evaluation of nodal status	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.	3 years	No
Secondary	Information on lymph node status in patients with breast cancer.	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.	3 years	No