Accuracy of a Positron Emission Tomography (PET) and Beta Probe in the Staging of Ductal Carcinoma In Situ & Invasive Ductal Cancer of the Breast.

Not Applicable

Recruiting

• Conditions: Breast cancer; Cancer - Breast

• Registration Number: ACTRN12610000300077
• Lead Sponsor: Curtin University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-04-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

1.Patient with newly diagnosed DCIS or invasive carcinoma of the breast;
2.Planned to undergo surgical wide local excision;
3.Able to provide informed consent.

Exclusion Criteria

1.Planned mastectomy or neoadjuvant therapy;
2.Uncontrolled diabetes mellitus;
3.Pregnant at the time of surgery;
4.Unable to provide informed consent.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy of the PET probe. Counts per second in areas where the probe has detected FDG will be recorded on the data collection sheet. This will be compared to the histology results, and in particular the clearance of the surgical margins and where there was not clearance, distance between the DCIS of invasive tissue and the margin/s.[Review all data after one year worth of recruitment]

Secondary Outcome Measures

Name	Time	Method
Confirm probe protocol. A good sensitivity and specificity based on the primary outcome confirms the protocol (injection dose and timing) is correct.[Review all data after one year worth of recruitment]