Pre-operative CT to improve delineation of the tumorbed in radiotherapy for breast cancer.

Completed

• Conditions: Breast cancer; 10027656; 10006295

• Registration Number: NL-OMON33679
• Lead Sponsor: MAASTRO clinic

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

Female patients with proven breast cancer, to be treated with breast conserving therapy, and a visible mass on mammography or ultrasound > 0.5 cm.

Exclusion Criteria

* All contra-indications for breast conserving therapy, i.e. pregnancy, multicentricity, inoperable disease, or a too large tumor in a relatively too small breast.
* All contra-indications for intravenous contrast, i.e. iodine allergy, renal malfunction (kreatinine clearance < 60 ml/min), , previous allergic reaction to i.v. contrast, M. Kahler, use of NSAIDs, Diuretics or Metformine.
* Absence of tumor mass > 0.5 cm on mammography or ultrasound.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1) The percentage of the PTV-2 receiving < 85% of the dose, if treated with<br /><br>the RT-plan for PTV-1.<br /><br>2) The volume receiving > 95% of the prescribed dose.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Other endpoints will be interobserver variation, as measured by<br /><br>1) percent volume overlap of the PTVs;<br /><br>2) difference in standard deviation of the average PTV-1 and PTV-2;<br /><br>3) center of mass assay.</p><br>