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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01432002

Enrollment

Registered

2011-09-12

Start date

2007-11-30

Completion date

2023-12-31

Last updated

2022-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasm

Keywords

breast carcinoma, FDG, PET/CT, PET/IRM

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

19 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Switzerland

Outcome results