Clinical trial · Observational
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
NCT01436591CI-TRIAL-00007994TEP-SeinterminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Performance of FDG-PET for the evaluation of nodal status
- timeFrame
- 3 years
- 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.
Secondary outcomes (1)
- measure
- Information on lymph node status in patients with breast cancer.
- timeFrame
- 3 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.