Infiltrating Ductal Carcinoma Clinical Trial
— VOSETEPOfficial title:
Contribution of 18FDG PET-Scan in Tumour Volume Determination in Patients Operated of Breast Cancer
| Verified date | June 2012 |
| Source | Centre Henri Becquerel |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | France: Institutional Ethical Committee |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | May 2012 |
| Est. primary completion date | May 2012 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| France | Centre Henri Becquerel | Rouen |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Henri Becquerel |
France,