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

Sponsor
University Hospital, Geneva (Other)
Overall Status
Unknown status
CT.gov ID
NCT01432002
Collaborator
(none)
60
1
121
0.5

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    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
    Study Start Date :
    Nov 1, 2007
    Actual Primary Completion Date :
    May 1, 2013
    Anticipated Study Completion Date :
    Dec 1, 2017

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Vincent Vinh-Hung, Privat Docent, University of Geneva, Switzerland
    ClinicalTrials.gov Identifier:
    NCT01432002
    Other Study ID Numbers:
    • HUG 07-153
    First Posted:
    Sep 12, 2011
    Last Update Posted:
    May 16, 2017
    Last Verified:
    May 1, 2017
    Keywords provided by Vincent Vinh-Hung, Privat Docent, University of Geneva, Switzerland
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 16, 2017