Optimizing the Delineation of the Tumour Bed in Breast Irradiation
1 other identifier
interventional
25
1 country
1
Brief Summary
The aim of the present study is:
- 1.to verify whether the delineation of the tumour bed, based on the combination of the visible postoperative changes and the position of the surgical clips on a CT scan in treatment position acquired 1 week before the start of the radiotherapy (RT), provides an accurate localisation of the boost volume compared to the localisation of the tumour on a pre-operative CT-scan.
- 2.to document the changes that occur in the tumour bed as seen on a CT scan as a function of the delay between surgery and radiotherapy.
- 3.to determine the ideal number and the positioning of the clips needed to reproduce the best treatment volume for the boost.
- 4.to propose new guidelines for tumour bed definition and delineation based on the study findings.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable breast-cancer
Started Feb 2012
Typical duration for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 28, 2015
CompletedFirst Posted
Study publicly available on registry
December 10, 2015
CompletedDecember 10, 2015
February 1, 2012
1.8 years
September 28, 2015
December 7, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
the interobserver variability (IOV) (%) of the delineated Clinical Target Volume (CTV) boost (cm3) with and without the fusion of the pre-operative CT-scan.
2 years
the volume of the delineated CTVboost (cm3) with and without the fusion of the pre-operative CT-scan.
2 years
Secondary Outcomes (3)
the correlation of the Cavity Visibility Scale (CVS) to volume changes and IOV
2 Years
the volume changes over time (in case of adjuvant chemotherapy)
2 years
the usefulness of the surgical clips assessed by the 6 observers.
2 years
Study Arms (1)
extra treatment planning CT-scan
OTHERExtra pre-operative CT-scan for treatment planning in RT
Interventions
Beside the standard post-operative CT-scan, an extra pre-operative CT-scan is performed.
Eligibility Criteria
You may qualify if:
- Breast Cancer patients, without metastases, who will undergo breast conserving surgery and probably will receive adjuvant chemotherapy and thereafter radiotherapy.
You may not qualify if:
- Metastases at time of diagnosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UZ Leuven
Leuven, 3000, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Caroline Weltens, PhD
Universitaire Ziekenhuizen KU Leuven
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2015
First Posted
December 10, 2015
Study Start
February 1, 2012
Primary Completion
December 1, 2013
Study Completion
July 1, 2015
Last Updated
December 10, 2015
Record last verified: 2012-02