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RecruitingNCT04343079Updated Jan 23, 2024

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

An interventional study of PET CT in Breast Cancer Female and Breast Neoplasms, sponsored by University Hospital, Ghent. Recruiting at 1 site in Belgium. Open to female participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-01-23.

Sponsored by University Hospital, Ghent · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Registered 2 years after the study started (first participant enrolled Jan 2018, registered Jan 2020).
  • Started Jan 2018; still recruiting 8 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
Female
01

Study summary

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

02

Conditions studied

  • Breast Cancer Female
  • Breast Neoplasms

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03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 100 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

University Hospital, Ghent is the lead sponsor of 665 studies on the registry; 156 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    braeast cancer

    breast cancer patients

    Diagnostic Test: PET CT

Interventions

  • Diagnostic testPET CT

    measurement of surgical margins during lumpectomy

06

What researchers measure

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

    Time frame: 2 year

07

Study locations

1 of 1 sites recruiting
  • University Hospital Ghent
    Ghent, Oost Vlaanderen 9000, Belgium
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04343079
Lead sponsor
University Hospital, Ghent
Responsible party
Sponsor
First posted
Apr 13, 2020
Start date
Jan 1, 2018
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Jan 23, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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