NCT04343079

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 13, 2020

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 23, 2024

Status Verified

January 1, 2024

Enrollment Period

7 years

First QC Date

January 20, 2020

Last Update Submit

January 20, 2024

Conditions

Breast Cancer FemaleBreast Neoplasms

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

braeast cancer

EXPERIMENTAL

breast cancer patients

Diagnostic Test: PET CT

Interventions

PET CTDIAGNOSTIC_TEST

measurement of surgical margins during lumpectomy

braeast cancer

Eligibility Criteria

Age18 Years - 85 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen with breast cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, Oost Vlaanderen, 9000, Belgium

RECRUITING

Related Publications (1)

  • 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.

    PMID: 41006264DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Positron-Emission TomographyTomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomography, X-Ray ComputedMultimodal ImagingRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2020

First Posted

April 13, 2020

Study Start

January 1, 2018

Primary Completion

December 31, 2024

Study Completion

December 31, 2025

Last Updated

January 23, 2024

Record last verified: 2024-01

Locations

BE(1)