Intra-operative PET-CT: a Novel Approach to Determine Excision Margins in Lumpectomy Breast Cancer.

Breast Neoplasms Clinical Trial

Official title:

Intra-operative PET-CT: a Novel Approach to Determine Excision Margins in Lumpectomy Breast Cancer.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04343079
• Other study ID #: EC/2017/0200
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Examination of the feasibility of intra-operative pet CT to detect surgical margins in breast conservative surgery to prevent re-excision.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• • female and 18 years of age or older

• diagnosed with an early-stage (T1 or T2, and N0 or N1; according to the TNM-classification) invasive breast cancer

• eligible for breast conserving surgery

Exclusion Criteria:

• • Pregnancy or lactation

• Diabetes

• Multifocal tumor disease

• Diagnosis of inflammatory breast cancer

• Appointment at the nuclear medicine department for 18F-FDG administration would result in a unacceptable delay of surgery

• Subject has had exposure to ionizing radiation of more than 1 mSv in other research studies within the last 12 months

• Subject has recently (<60 days) or is simultaneously participating in another clinical trial.

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms

Intervention

Diagnostic Test:
• PET CT
measurement of surgical margins during lumpectomy

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent	Oost Vlaanderen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	investigate the ability of (micro)PET/CT to evaluate the excision margins and determine negativity of these margins, as compared to the gold standard of sectional histopathological evaluation.	study the feasibility of PET/CT	2 year