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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


N/A
19 Years
N/A
Open (Enrolling)
Female
Breast Neoplasm

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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

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