Infiltrating Ductal CarcinomaVOSETEPNCT01621529
Contribution of 18FDG PET-Scan in Tumour Volume Determination in Patients Operated of Breast Cancer
An observational study of Infiltrating Ductal Carcinoma, run by Centre Henri Becquerel at 1 site in France.
Trial summary
Use of positron emission tomography (PET) in determination of functional tumour volume can provide usable information for radiotherapy to define the irradiated volume. To determine the best tumour volume measure method, the investigators have chosen as model the breast cancer which allows us to study a stationary or… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Infiltrating Ductal Carcinoma
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2010to May 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: patient with invasive non-lobular breast cancer, histologically proved
Who may be able to join
- Invasive non-lobular breast cancer, histologically proven by biopsy
- Tumour T2 - T3 regardless of nodal status, stemming from a primary surgery, in whom FDG-PET is performed for staging
- Age greater than or equal to 18 years
- Good condition: WHO lower 2.
- Women receiving effective contraception throughout the duration of treatment and 3 months after cessation of treatment,
- Patient has signed informed consent
Who cannot join
- Carcinoma other than breast ductal carcinoma.
- Patients for whom no target tumor is assessable.
- Patients for whom surgery first of their breast cancer is not indicated (tumor spread, metastasis, general health, co-morbidities).
- Pregnant women, or likely to be during breastfeeding.
- Major protected (under supervision and under guardianship)
- Failure to submit to medical supervision of the study for reasons of geography, social or psychological
- Incomplete tumor resection
Trial locations and contacts
1 site in 1 country.
About this study
Use of positron emission tomography (PET) in determination of functional tumour volume can provide usable information for radiotherapy to define the irradiated volume.
To determine the best tumour volume measure method, the investigators have chosen as model the breast cancer which allows us to study a stationary or moving organ by the patient position and belonging to a primary surgery.
Read more
The used methodology is based on lesion volume measure in preoperative time, obtained with PET, and on the measure of specimen volume by the anatomic laboratory after surgery.
This study's main objective is to compare this two measure of tumour size and secondarily to compare TEP with or without respiratory gating.
The PET-scan is achieved with FDG, under his French permission marketing, and acquire in 3 times:
A whole body acquisition in supine position, follow by a centered tumour acquisition with respiratory gating, then an acquisition in prone position to immobilise the lesion.
This study is monocentric and descriptive. It provides to include 30 patients in 1 year.
Read the detailed description
The use of positron emission tomography (PET) in determination of functional tumour volume may pose two major problems especially for the exact delineation of tumour contours:
- Respiratory movements, when the tumour is thoracic, may induce an overestimation
- The PET's low spatial resolution, linked to the emission of photons
The usual method to define tumour contours result of three types of delineation usually used: the visual contouring, the segmentation based on an activity threshold fixed, and the segmentation with adaptive thresholding.
- Conditions
- Infiltrating Ductal Carcinoma
- Keywords
- Positron-Emission Tomography, PET Scan, FDG, SUV, Invasive Breast cancer, Surgery compare, Tumor measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2012 (estimated)
- Study startFeb 2010
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infiltrating Ductal CarcinomaStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Henri Becquerel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pierre Vera, Centre Henri Becquerel
- Investigators
- Pierre VERA, PhD, Principal investigator, Centre H.Becquerel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01621529
- Sponsor's protocol ID
- CHB 09.01
- Acronym
- VOSETEP
- Status last verified
- Jun 2012
- First submitted
- 14 Jun 2012
- Last updated
- 18 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of 18FDG PET-Scan in Tumour Volume Determination in Patients Operated of Breast Cancer
- ClinicalTrials.gov ID
- NCT01621529
- Acronym / sponsor ID
- VOSETEP / CHB 09.01
- Conditions
- Infiltrating Ductal Carcinoma
- Keywords
- Positron-Emission Tomography, PET Scan, FDG, SUV, Invasive Breast cancer, Surgery compare, Tumor measurement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Henri BecquerelUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 18 Jun 2012 (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.
Use of positron emission tomography (PET) in determination of functional tumour volume can provide usable information for radiotherapy to define the irradiated volume.
To determine the best tumour volume measure method, the investigators have chosen as model the breast cancer which allows us to study a stationary or moving organ by the patient position and belonging to a primary surgery.
The used methodology is based on lesion volume measure in preoperative time, obtained with PET, and on the measure of specimen volume by the anatomic laboratory after surgery.
This study's main objective is to compare this two measure of tumour size and secondarily to compare TEP with or without respiratory gating.
The PET-scan is achieved with FDG, under his French permission marketing, and acquire in 3 times:
A whole body acquisition in supine position, follow by a centered tumour acquisition with respiratory gating, then an acquisition in prone position to immobilise the lesion.
This study is monocentric and descriptive. It provides to include 30 patients in 1 year.
Detailed description
The use of positron emission tomography (PET) in determination of functional tumour volume may pose two major problems especially for the exact delineation of tumour contours:
- Respiratory movements, when the tumour is thoracic, may induce an overestimation
- The PET's low spatial resolution, linked to the emission of photons
The usual method to define tumour contours result of three types of delineation usually used: the visual contouring, the segmentation based on an activity threshold fixed, and the segmentation with adaptive thresholding.
Study design
- Observational model
- Cohort
- 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
- patient with invasive non-lobular breast cancer, histologically proved
Key inclusion criteria (6 listed)
- Invasive non-lobular breast cancer, histologically proven by biopsy
- Tumour T2 - T3 regardless of nodal status, stemming from a primary surgery, in whom FDG-PET is performed for staging
- Age greater than or equal to 18 years
- Good condition: WHO lower 2.
- Women receiving effective contraception throughout the duration of treatment and 3 months after cessation of treatment,
Key exclusion criteria (7 listed)
- Carcinoma other than breast ductal carcinoma.
- Patients for whom no target tumor is assessable.
- Patients for whom surgery first of their breast cancer is not indicated (tumor spread, metastasis, general health, co-morbidities).
- Pregnant women, or likely to be during breastfeeding.
- Major protected (under supervision and under guardianship)
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 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.
Pierre VERA, PhD principal investigator
Centre H.Becquerel
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 Infiltrating Ductal Carcinoma, run by Centre Henri Becquerel 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 7 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: finished, as of the sponsor's last update on 18 Jun 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 18 Jun 2012.