Optimizing the Delineation of the Tumour Bed in Breast Irradiation

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02626858

Enrollment

Registered

2015-12-10

Start date

2012-02-29

Completion date

2015-07-31

Last updated

2015-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Detailed description

Start of the study: february 2012

Interventions

DEVICEextra treatment planning CT-scan

Beside the standard post-operative CT-scan, an extra pre-operative CT-scan is performed.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Inclusion criteria

* Breast Cancer patients, without metastases, who will undergo breast conserving surgery and probably will receive adjuvant chemotherapy and thereafter radiotherapy.

Exclusion criteria

* Metastases at time of diagnosis

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026