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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.
 
ClinicalTrials.gov Identifier: NCT01621529
Recruitment Status : Completed
First Posted : June 18, 2012
Last Update Posted : June 18, 2012
Sponsor:
Information provided by (Responsible Party):
Pierre Vera, Centre Henri Becquerel

Tracking Information
First Submitted Date June 14, 2012
First Posted Date June 18, 2012
Last Update Posted Date June 18, 2012
Study Start Date February 2010
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Contribution of 18FDG PET-Scan in Tumour Volume Determination in Patients Operated of Breast Cancer
Official Title Contribution of 18FDG PET-Scan in Tumour Volume Determination in Patients Operated of Breast Cancer
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.

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population patient with invasive non-lobular breast cancer, histologically proved
Condition Infiltrating Ductal Carcinoma
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June¬†15,¬†2012)
30
Original Actual Enrollment Same as current
Actual Study Completion Date May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01621529
Other Study ID Numbers CHB 09.01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pierre Vera, Centre Henri Becquerel
Study Sponsor Centre Henri Becquerel
Collaborators Not Provided
Investigators
Principal Investigator: Pierre VERA, PhD Centre H.Becquerel
PRS Account Centre Henri Becquerel
Verification Date June 2012