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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01621529
Recruitment Status : Completed
First Posted : June 18, 2012
Last Update Posted : June 18, 2012
Information provided by (Responsible Party):
Pierre Vera, Centre Henri Becquerel

Brief Summary:

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 or disease
Infiltrating Ductal Carcinoma

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.

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Contribution of 18FDG PET-Scan in Tumour Volume Determination in Patients Operated of Breast Cancer
Study Start Date : February 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patient with invasive non-lobular breast cancer, histologically proved

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01621529

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Centre Henri Becquerel
Rouen, France, 76000
Sponsors and Collaborators
Centre Henri Becquerel
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Principal Investigator: Pierre VERA, PhD Centre H.Becquerel
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Responsible Party: Pierre Vera, heads of nuclear medecine department, Centre Henri Becquerel Identifier: NCT01621529    
Other Study ID Numbers: CHB 09.01
First Posted: June 18, 2012    Key Record Dates
Last Update Posted: June 18, 2012
Last Verified: June 2012
Keywords provided by Pierre Vera, Centre Henri Becquerel:
Positron-Emission Tomography
PET Scan
Invasive Breast cancer
Surgery compare
Tumor measurement
Additional relevant MeSH terms:
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Carcinoma, Ductal
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary