This trial is active, not recruiting.

Condition breast neoplasm
Sponsor University Hospital, Geneva
Start date November 2007
End date May 2013
Trial size 60 participants
Trial identifier NCT01432002, HUG 07-153


The purpose of the study is:

- to assess the potential benefits of 18F-[FDG] PET/CT and PET/MRI for operable breast cancer in order to define the size and location of the primary tumor, as well as axillary, supraclavicular and internal mammary lymph nodes.

- to apply the imaging results to the simulation and the radiation treatment planning and partial breast for 3-D radiation treatment and partial breast irradiation with intensity modulated radiation treatment (IMRT).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Drawing of target volumes
time frame: Up to 12 weeks after surgery

Secondary Outcomes

Correlate the FDG PET/CT PET/IRM with surgical pathology findings
time frame: Up to 12 weeks after surgery

Eligibility Criteria

Female participants at least 19 years old.

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.

Additional Information

Official title 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
Principal investigator Vincent Vinh-Hung, MD, PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by University Hospital, Geneva.