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

December 18, 2022 updated by: Vincent Vinh-Hung, University Hospital, Geneva

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

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).

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Geneva, Switzerland, 1205
        • Radiation oncology, Geneva University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women with operable clinically node-negative breast cancer

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drawing of target volumes
Time Frame: Up to 12 weeks after surgery
Compare the drawing of target volumes using the PET/CT, PET/IRM information, or without these imaging informations.
Up to 12 weeks after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlate the FDG PET/CT PET/IRM with surgical pathology findings
Time Frame: 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.
Up to 12 weeks after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Investigators

  • Principal Investigator: Vincent Vinh-Hung, MD, PhD, Radiation oncology, Geneva University Hospitals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

May 1, 2013

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

September 2, 2011

First Submitted That Met QC Criteria

September 8, 2011

First Posted (Estimate)

September 12, 2011

Study Record Updates

Last Update Posted (Estimate)

December 21, 2022

Last Update Submitted That Met QC Criteria

December 18, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUG 07-153

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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