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

NCT ID: NCT04343079

Last Updated: 2024-01-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2025-12-31

Brief Summary

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

Conditions

Breast Cancer Female; Breast Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

braeast cancer

breast cancer patients

Group Type: EXPERIMENTAL

PET CT

Intervention Type: DIAGNOSTIC_TEST

measurement of surgical margins during lumpectomy

Interventions

PET CT

measurement of surgical margins during lumpectomy

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital Ghent

Ghent, Oost Vlaanderen, Belgium

Site Status: RECRUITING

Countries

Belgium

Facility Contacts

Menekse Goker

Role: primary

menekse.goker@uzgent.be

0498677037

References

De Crem AS, Tummers P, Depypere H, Braems G, Salihi R, Vergauwen G, Cisternino G, Van de Vijver K, De Visschere P, De Man K, Van den Broeck B, Hendrickx S, Veldeman L, Monten C, Debacker JM, Denys H, Goker M. Breast cancer Intraoperative Margin Assessment using specimen PET-CT (BIMAP). NPJ Breast Cancer. 2025 Sep 26;11(1):101. doi: 10.1038/s41523-025-00818-8.

Reference Type: DERIVED

PMID: 41006264 (View on PubMed)

Other Identifiers

EC/2017/0200

Identifier Type: -

Identifier Source: org_study_id