Breast CancerTEP-SeinNCT01436591
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
An observational study of Breast Cancer, run by Centre Francois Baclesse at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 63 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2009to Aug 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Preoperative assessment of breast cancer.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Persons deprived of their liberty
- Major subject of a measure of legal protection or unable to consent
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
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
- Breast Cancer
- Keywords
- Cancer, Breast, 18FDG, Axillary, Positron Emission Tomography
- Medical subject headings
- Breast Neoplasms, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (1)
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2011 (estimated)
- Study startMar 2009
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- SWITSERS Odile, Dr, Principal investigator, Centre François Baclesse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01436591
- Sponsor's protocol ID
- TEP-Sein
- Acronym
- TEP-Sein
- Status last verified
- Sep 2012
- First submitted
- 15 Sep 2011
- Last updated
- 10 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01436591
- Acronym / sponsor ID
- TEP-Sein / TEP-Sein
- Conditions
- Breast Cancer
- Keywords
- Cancer, Breast, 18FDG, Axillary, Positron Emission Tomography
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 19 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Preoperative assessment of breast cancer.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Performance of FDG-PET for the evaluation of nodal status
Time frame: 3 years
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.
1 secondary outcome
Information on lymph node status in patients with breast cancer.
Time frame: 3 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SWITSERS Odile, Dr principal investigator
Centre François Baclesse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Centre Francois Baclesse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of FDG-PET for the evaluation of nodal status (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2012.