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: September 7, 2014
Last verified: September 2014
  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 2015
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: September 7, 2014
Health Authority: Switzerland: Swissmedic

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

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

ClinicalTrials.gov processed this record on September 18, 2014