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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Vincent Vinh-Hung, University of Geneva, Switzerland
ClinicalTrials.gov Identifier:
NCT01432002
First received: September 2, 2011
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

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).

Condition
Breast Neoplasm

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • Drawing of target volumes [ Time Frame: Up to 12 weeks after surgery ] [ Designated as safety issue: No ]
    Compare the drawing of target volumes using the PET/CT, PET/IRM information, or without these imaging informations.


Secondary Outcome Measures:
  • Correlate the FDG PET/CT PET/IRM with surgical pathology findings [ Time Frame: Up to 12 weeks after surgery ] [ Designated as safety issue: No ]
    Compare the pre-operative imaging information with histopathological description of the resected primary tumor, and with the extent of lymph node involvement.


Estimated Enrollment: 60
Study Start Date: November 2007
Estimated Study Completion Date: December 2014
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women with operable clinically node-negative breast cancer

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01432002

Locations
Switzerland
Radiation oncology, Geneva University Hospitals
Geneva, Switzerland, 1205
Sponsors and Collaborators
University Hospital, Geneva
Investigators
Principal Investigator: Vincent Vinh-Hung, MD, PhD Radiation Oncology, Geneva University Hospitals
  More Information

Publications:
Responsible Party: Vincent Vinh-Hung, Privat Docent, University of Geneva, Switzerland
ClinicalTrials.gov Identifier: NCT01432002     History of Changes
Other Study ID Numbers: HUG 07-153
Study First Received: September 2, 2011
Last Updated: December 17, 2013
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Geneva:
breast carcinoma
FDG
PET/CT
PET/IRM

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014