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

Ghent University Hospital (UZ)

Status: Enrolling

Conditions: Breast Cancer Female; Breast Neoplasms

Treatments: Diagnostic Test: PET CT

Study type: Interventional

Funder types: Other

Identifiers

NCT04343079

EC/2017/0200

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

braeast cancer

Experimental group

Description:

breast cancer patients

Treatment:

Diagnostic Test: PET CT