Optimizing the Delineation of the Tumour Bed in Breast Irradiation

NCT ID: NCT02626858

Last Updated: 2015-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2015-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Start of the study: february 2012

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

extra treatment planning CT-scan

Extra pre-operative CT-scan for treatment planning in RT

Group Type OTHER

extra treatment planning CT-scan

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

extra treatment planning CT-scan

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Caroline Weltens, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UZ Leuven

Leuven, , Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

s54017

Identifier Type: -

Identifier Source: org_study_id