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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

NCT ID: NCT01436591

Last Updated: 2012-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

63 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-31

Study Completion Date

2012-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Keywords

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Cancer Breast 18FDG Axillary Positron Emission Tomography

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Francois Baclesse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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SWITSERS Odile, Dr

Role: PRINCIPAL_INVESTIGATOR

Centre François Baclesse

Locations

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Centre François Baclesse

Caen, , France

Site Status

Countries

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France

Other Identifiers

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TEP-Sein

Identifier Type: -

Identifier Source: org_study_id