FDG-PET/CT for Simulation and Radiation Treatment Planning of Early Breast Cancer

N/AUnknownNCT01432002

University Hospital, Geneva60 enrolled

Overview

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).

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Breast Neoplasm

Eligibility

Sex: FEMALEMin age: 19 Years

Medical Language ↔ Plain English

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.

Locations (1)

Radiation oncology, Geneva University Hospitals

Geneva, Switzerland

Outcomes

Primary Outcomes

Drawing of target volumes

Compare the drawing of target volumes using the PET/CT, PET/IRM information, or without these imaging informations.

Time frame: Up to 12 weeks after surgery

Secondary Outcomes

Correlate the FDG PET/CT PET/IRM with surgical pathology findings

Compare the pre-operative imaging information with histopathological description of the resected primary tumor, and with the extent of lymph node involvement.

Time frame: Up to 12 weeks after surgery

Data from ClinicalTrials.gov

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