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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

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01436591
Acronym
TEP-Sein
Enrollment
63
Registered
2011-09-19
Start date
2009-03-31
Completion date
2012-08-31
Last updated
2012-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Cancer, Breast, 18FDG, Axillary, Positron Emission Tomography

Brief 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.

Interventions

None listed

Sponsors

Centre Francois Baclesse
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Performance of FDG-PET for the evaluation of nodal status3 yearsShow 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

MeasureTime frameDescription
Information on lymph node status in patients with breast cancer.3 yearsShow 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026