Contribution of 18FDG PET-Scan in Tumour Volume Determination in Patients Operated of Breast Cancer (VOSETEP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pierre Vera, Centre Henri Becquerel
ClinicalTrials.gov Identifier:
NCT01621529
First received: June 14, 2012
Last updated: June 15, 2012
Last verified: June 2012
  Purpose

Use of positron emission tomography (PET) in determination of functional tumour volume can provide usable information for radiotherapy to define the irradiated volume.

To determine the best tumour volume measure method, the investigators have chosen as model the breast cancer which allows us to study a stationary or moving organ by the patient position and belonging to a primary surgery.

The used methodology is based on lesion volume measure in preoperative time, obtained with PET, and on the measure of specimen volume by the anatomic laboratory after surgery.

This study's main objective is to compare this two measure of tumour size and secondarily to compare TEP with or without respiratory gating.

The PET-scan is achieved with FDG, under his French permission marketing, and acquire in 3 times:

A whole body acquisition in supine position, follow by a centered tumour acquisition with respiratory gating, then an acquisition in prone position to immobilise the lesion.

This study is monocentric and descriptive. It provides to include 30 patients in 1 year.


Condition
Infiltrating Ductal Carcinoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Contribution of 18FDG PET-Scan in Tumour Volume Determination in Patients Operated of Breast Cancer

Resource links provided by NLM:


Further study details as provided by Centre Henri Becquerel:

Enrollment: 30
Study Start Date: February 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Detailed Description:

The use of positron emission tomography (PET) in determination of functional tumour volume may pose two major problems especially for the exact delineation of tumour contours:

  • Respiratory movements, when the tumour is thoracic, may induce an overestimation
  • The PET's low spatial resolution, linked to the emission of photons

The usual method to define tumour contours result of three types of delineation usually used: the visual contouring, the segmentation based on an activity threshold fixed, and the segmentation with adaptive thresholding.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patient with invasive non-lobular breast cancer, histologically proved

Criteria

Inclusion Criteria:

  • Invasive non-lobular breast cancer, histologically proven by biopsy
  • Tumour T2 - T3 regardless of nodal status, stemming from a primary surgery, in whom FDG-PET is performed for staging
  • Age greater than or equal to 18 years
  • Good condition: WHO lower 2.
  • Women receiving effective contraception throughout the duration of treatment and 3 months after cessation of treatment,
  • Patient has signed informed consent

Exclusion Criteria:

  • Carcinoma other than breast ductal carcinoma.
  • Patients for whom no target tumor is assessable.
  • Patients for whom surgery first of their breast cancer is not indicated (tumor spread, metastasis, general health, co-morbidities).
  • Pregnant women, or likely to be during breastfeeding.
  • Major protected (under supervision and under guardianship)
  • Failure to submit to medical supervision of the study for reasons of geography, social or psychological
  • Incomplete tumor resection
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01621529

Locations
France
Centre Henri Becquerel
Rouen, France, 76000
Sponsors and Collaborators
Centre Henri Becquerel
Investigators
Principal Investigator: Pierre VERA, PhD Centre H.Becquerel
  More Information

No publications provided

Responsible Party: Pierre Vera, heads of nuclear medecine department, Centre Henri Becquerel
ClinicalTrials.gov Identifier: NCT01621529     History of Changes
Other Study ID Numbers: CHB 09.01
Study First Received: June 14, 2012
Last Updated: June 15, 2012
Health Authority: France: Institutional Ethical Committee

Keywords provided by Centre Henri Becquerel:
Positron-Emission Tomography
PET Scan
FDG
SUV
Invasive Breast cancer
Surgery compare
Tumor measurement

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma, Ductal
Carcinoma, Ductal, Breast
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary

ClinicalTrials.gov processed this record on September 18, 2014