NCT01436591

Terminated

Comparison of Diagnostic Performance of an Algorithm and a H...

Centre Francois Baclesse Source

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

TEP-Sein

Study Type

observational

Actual enrollment (reported)

63

Locations

1 country

Sites

1

Timeline

Study Start

March 2009

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

August 2012

Actual (reported)

Study Completion

August 2012

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 63 participants
Study completion date: August 2012
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
March 2009
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 15, 2011
Actual (reported)
First Posted
September 19, 2011
Actual (reported)
Primary Completion
August 2012
Actual (reported)
Study Completion
August 2012
Actual (reported)

Last Updated: September 10, 2012
Status Verified: September 2012
Last Update Submitted: September 7, 2012

Conditions

Breast Cancer

Keywords

CancerBreast18FDGAxillaryPositron Emission Tomography

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

Information on lymph node status in patients with breast cancer.
3 years

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Preoperative assessment of breast cancer.

You may qualify if:

Informed consent and signed by the patient

Sponsors & Collaborators

Centre Francois Baclesse
Otherlead

Study Sites (1)

Centre François Baclesse

Caen, 14076, France

MeSH Terms

Conditions

Breast NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

SWITSERS Odile, Dr
Centre François Baclesse
PRINCIPAL INVESTIGATOR

Enrollment

63 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 15, 2011

First Posted

September 19, 2011

Study Start

March 2009

Date type not reported

This date has not been verified as actual or estimated.

NCT00534274

Positron Emission Tomography Using 3'-Deoxy-3'-(18F) Fluorothymidine in Treating Women With Locally Advanced Cancer in One Breast Who Are Receiving Chemotherapy

Not ApplicableCompleted

NCT00636467

Axillary Sentinel Lymph Node Detection in Breast Cancers > 2 cm

Phase 2Completed

NCT00893061

Letrozole, Anastrozole, Exemestane, or Tamoxifen Citrate in Treating Postmenopausal Women With Breast Cancer

Phase 3Completed

NCT01180335

Standard Neoadjuvant Chemotherapy Versus Genomic Driven Chemotherapy in Patients With Breast Cancer

Phase 3Completed

NCT00949598

Letrozole or Tamoxifen Citrate in Treating Older Postmenopausal Women Undergoing Surgery for Breast Cancer

Phase 3Completed

NCT00953537

Predicting Response to Capecitabine in Women With Metastatic Breast Cancer

Not ApplicableCompleted

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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Primary Completion

August 2012

Actual (reported)

Study Completion

August 2012

Actual (reported)

Last Updated

September 10, 2012

Record last verified: 2012-09

Source record

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Source: ClinicalTrials.gov.

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Registry identifier: NCT01436591
Data provider: ClinicalTrials.gov
Source updated: 2012-09-10
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:32:22 UTC

Locations

FR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations