Breast Cancer FemaleNCT04343079
Intra-operative PET-CT: a Novel Approach to Determine Excision Margins in Lumpectomy Breast Cancer.
A study testing PET CT in people with Breast Cancer Female and Breast Neoplasms, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Examination of the feasibility of intra-operative pet CT to detect surgical margins in breast conservative surgery to prevent re-excision. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Breast Cancer Female, Breast Neoplasms
- What is being tested?
- PET CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2018to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- • 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 locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University Hospital Ghent
Ghent, Oost Vlaanderen, 9000
Menekse Goker, 0498677037, menekse.goker@uzgent.be
About this study
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
- Being tested
- PET CT
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET CTDiagnostic test
measurement of surgical margins during lumpectomy
| Study group | Role | What they receive |
|---|---|---|
| braeast cancer | Experimental | breast cancer patients Receives: Diagnostic Test: PET CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start1 Jan 2018
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04343079
- Sponsor's protocol ID
- EC/2017/0200
- Status last verified
- Jan 2024
- First submitted
- 20 Jan 2020
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41006264
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-operative PET-CT: a Novel Approach to Determine Excision Margins in Lumpectomy Breast Cancer.
- ClinicalTrials.gov ID
- NCT04343079
- Acronym / sponsor ID
- EC/2017/0200
- Conditions
- Breast Cancer Female, Breast Neoplasms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Examination of the feasibility of intra-operative pet CT to detect surgical margins in breast conservative surgery to prevent re-excision.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| braeast cancer | Experimental | Diagnostic Test: PET CTbreast cancer patients |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • female and 18 years of age or older
Key exclusion criteria (7 listed)
- • Pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET CTmeasurement of surgical margins during lumpectomy | Diagnostic test | braeast cancer |
Primary outcome
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.
Time frame: 2 year
study the feasibility of PET/CT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Derived from this study: PubMed 41006264De 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET CT in people with Breast Cancer Female and Breast Neoplasms, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04343079, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.