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

Active, not recruiting

• Conditions: Breast Neoplasm

• Registration Number: NCT01432002
• Lead Sponsor: University Hospital, Geneva

Brief Summary

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).

Detailed 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.

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2011-09-02
• Study First Submitted QC: 2011-09-08
• Study First Posted: 2011-09-12
• Primary Completion: 2013-05
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-18
• Last Update Posted: 2022-12-21
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Drawing of target volumes	Up to 12 weeks after surgery	Compare the drawing of target volumes using the PET/CT, PET/IRM information, or without these imaging informations.

Secondary Outcome Measures

Name	Time	Method
Correlate the FDG PET/CT PET/IRM with surgical pathology findings	Up to 12 weeks after surgery	Compare the pre-operative imaging information with histopathological description of the resected primary tumor, and with the extent of lymph node involvement.

Trial Locations

Locations (1)

Radiation oncology, Geneva University Hospitals; 🇨🇭 Geneva, Switzerland