Trial Information
Application of 18F-[FDG] PET/CT to Simulation and Planning of Radiotherapy (RT) for Breast Cancer. Definition of Target Volume for 3-D RT and for Partial Breast Irradiation (PBI) by IMRT Technique
Pre-operative FDG PET/CT, and in option PET/IRM, are intended for women with histologically
confirmed operable clinically node-negative breast cancer, in whom breast conserving and
post-operative radiotherapy are planned.
Inclusion Criteria:
- Histologically confirmed breast carcinoma
- Clinical stage T1-2 N0 M0
- Age > 18 years
- Signed informed consent
Exclusion Criteria:
- WHO performance index 3
- Premenopausal women without contraception
- Gestation
- Lactating
- Prior surgery or radiotherapy on the same breast
- Unable to understand study participation
- Bilateral breast cancer
- Prior CT thorax-abdomen and breast MRI within 4 months of interview
- Presence of electromechanical implant and/or body ferromagnetic material
- Previous history of renal insufficiency requiring dialysis and/or hospitalisation
- Ureum and/or creatinine within 2 weeks of interview above lab's reference limits
- History of contrast allergy
- Hyperthyroidy
- Claustrophobia.
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Drawing of target volumes
Outcome Description:
Compare the drawing of target volumes using the PET/CT, PET/IRM information, or without these imaging informations.
Outcome Time Frame:
Up to 12 weeks after surgery
Safety Issue:
No
Principal Investigator
Vincent Vinh-Hung, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Radiation Oncology, Geneva University Hospitals
Authority:
Switzerland: Swissmedic
Study ID:
HUG 07-153
NCT ID:
NCT01432002
Start Date:
November 2007
Completion Date:
October 2013
Related Keywords:
- Breast Neoplasm
- breast carcinoma
- FDG
- PET/CT
- PET/IRM
- Breast Neoplasms
- Neoplasms