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Breast CancerBrIMANCT04999917

Specimen PET-CT Imaging for Intraoperative Margin Assessment in Breast Cancer

A study testing high-resolution PET-CT specimen imaging. in people with Breast Cancer and Breast Cancer Invasive, run by XEOS Medical at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Breast-conserving surgery (BCS) has become the standard-of-care for surgical management of the majority of women with early-stage breast cancer. Successful BCS entails excision of the tumor with an adequate amount of surrounding healthy breast parenchyma, such that negative resection margins are obtained. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
high-resolution PET-CT specimen imaging.
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
206 participants
Where
1 siteBelgium
Study dates
17 Jun 2022to 3 Apr 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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • females with an age over 18 years;
  • confirmed breast cancer (IDC, DCIS, ILC) with indication to undergo BCS;
  • a minimal tumor size of 1.0 cm (in at least one dimension):
  • IDC group: assessed preoperatively on ultrasound;
  • DCIS subgroup: assessed preoperatively on mammogram;
  • ILC subgroup: assessed preoperatively on ultrasound;
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  • NAT subgroup: assessed after NAT and before surgery on ultrasound;
  • patients with IDC who have received NAT (i.e. chemotherapy, immunotherapy or endocrine therapy until eight weeks before BCS) may participate in the study;
  • vacuum-assisted core breast biopsy is allowed in the DCIS subgroup only;
  • able to understand treatment protocol and informed consent form;
  • estimated by the investigator to be compliant for study participation.

Who cannot join

  • general or local contra-indication for BCS;
  • previous breast surgery;
  • inflammatory breast cancer;
  • radiotherapy of the ipsilateral breast;
  • vacuum-assisted core breast biopsy for all patients allocated to the IDC, ILC or NAT subgroup (vacuum-assisted core breast biopsy is allowed in the DCIS subgroup as long as the residual tumor size on mammogram is at least 1.0 cm);
  • patients with DCIS only or ILC, and that have received NAT;
Show all 10Show fewer
  • blood glucose level over 200 mg/dL on the day of surgery;
  • pregnancy or lactation;
  • participation in other clinical studies with a radiation exposure of more than 1 mSv in the past year;
  • active bacterial, viral or fungal infection.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Gynecology department

    Ghent, Flanders, 9000

Other trials in Belgium

About this study

Official title: High-resolution PET-CT Imaging for Intraoperative Margin Assessment in Early-stage Breast Cancer: a Prospective Multicentric Interventional Clinical Study

Breast-conserving surgery (BCS) has become the standard-of-care for surgical management of the majority of women with early-stage breast cancer. Successful BCS entails excision of the tumor with an adequate amount of surrounding healthy breast parenchyma, such that negative resection margins are obtained. Despite efforts to obtain tumor-free margins, approximately 20-30% of women still require reoperation.

The rationale of this study is to examine the contribution of the adjunctive use of perioperative high-resolution PET-CT specimen imaging in early-stage breast cancer to the identification of all positive resection margins during breast-conserving surgery. Histopathological findings of the breast tumor specimen are applied as the gold standard.

After a successful screening phase and after informed consent is provided, the patient will enroll the study. The preparations for the BCS proceed following the routine protocol (i.e. as if the patient would not participate in the study). In addition to these standard preparations, on the day of surgery the patient will receive a study-specific injection with a low dose of a radiotracer substance (18F-FDG; 0.8 MBq/kg). Before injection, the blood sugar level will be measured by a small finger prick. If the blood sugar level is good, the radiotracer substance will be intravenously administered. The injection is given at the nuclear medicine department between 30 minutes and 3 hours before surgery. After the injection was given, the patient will be transferred to the operating theatre. The breast tumor will be removed in the same way as if the patient is not participating in the study. As soon as the tumor is excised, it will be imaged using the specimen PET-CT scanner in the operating theatre. While waiting for these 3D images, the surgeon will remove the lymph nodes, if applicable. The breast surgeon will then evaluate the 3D images of the removed breast tumor. In case of suspected positive margins, the surgeon will excise additional breast tissue to ensure that all tumor tissue is excised during this surgery. For scientific purposes only and if available, the cavity shaves and resected lymph nodes will also be imaged with the specimen PET-CT scanner. No clinical decisions that could affect further treatment will be based on this. After surgery, all excised tissues will be sent to the pathology department. This is standard routine and is also done for patients not participating in the study. A routine follow-up visit will be planned with the surgeon. During that routine visit, a staff member of the study team will ask additional study-related questions regarding possible complications. If the latter is not possible during the standard follow-up visit, a staff member of the study team will contact the patient by phone call 1-3 weeks after surgery. The study is completed after this follow-up visit or phone call.

Being tested
high-resolution PET-CT specimen imaging.
Keywords
PET-CT, margin assessment, breast conserving surgery
Medical subject headings
Breast Neoplasms, Breast Carcinoma In Situ

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • high-resolution PET-CT specimen imaging.Diagnostic test

    A single intravenous injection of 18F-FDG (0.80 MBq/kg) is given between 30 minutes and 3 hours before tumor resection.

    Surgical resection of the breast tumor (= main specimen) under general anesthesia.

    The main specimen is imaged using the Aura 10 PET-CT Specimen Imager (XEOS Medical, Ghent, Belgium). In case of positive margins, the surgeon will perform oriented cavity shaving. The cavity shaves and lymph nodes (if any) are also imaged using the Aura 10 PET-CT Specimen Imager (for scientific purposes only).

    The main specimen and if applicable the cavity shaves and lymph node(s) are processed following standard-of-care routine: from tissue samples to HE-stained and IHC-stained sections. The histopathological margin status shall be reported according to the ASCO-CAP guidelines, and shall be compared to the PET-CT images of the resected specimens.

Study groups in NCT04999917
Study groupRoleWhat they receive
intraoperative high-resolution PET-CT imaging of resected breast tumor.ExperimentalNot described
Receives: Diagnostic Test: high-resolution PET-CT specimen imaging.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Perioperative addressing positive margins of the invasive component in IDC.

    The primary effectiveness endpoint is a measure of perioperative success in addressing positive margins of the invasive component with the adjunctive use of high-resolution PET-CT specimen imaging as detected by permanent pathology in the IDC subgroup.

    Measured: Perioperative (day 0).

Secondary outcomes (11)

  1. Perioperative addressing positive margins of the invasive component in breast cancer.

    A measure of perioperative success in addressing positive margins of the invasive component with the adjunctive use of high-resolution PET-CT specimen imaging as detected by permanent pathology in:

    • the total study population excluding the DCIS subgroup (IDC + ILC + NAT);
    • the ILC subgroup;
    • the NAT subgroup.

    Measured: Perioperative (day 0).

  2. Perioperative addressing any positive margin in breast cancer.

    A measure of perioperative success in addressing any positive margin with the adjunctive use of high-resolution PET-CT specimen imaging as detected by permanent pathology in:

    • the total study population (IDC + DCIS + ILC + NAT);
    • the IDC subgroup;
    • the DCIS subgroup;
    • the ILC subgroup;
    • the NAT subgroup.

    Measured: Perioperative (day 0).

  3. Perioperative success in obtaining final negative margins of the invasive component in breast cancer.

    A measure of perioperative success in obtaining final negative margins of the invasive component as detected by permanent pathology (1) by the additional use of high-resolution PET-CT imaging and (2) by additional use of standard-of-care in:

    • the total study population excluding DCIS (IDC + ILC + NAT);
    • the IDC subgroup;
    • the ILC subgroup;
    • the NAT subgroup.

    Measured: Perioperative (day 0).

  4. Perioperative success in obtaining final negative margins in breast cancer.

    A measure of perioperative success in obtaining final negative margins (invasive and/or in situ component) as detected by permanent pathology (1) by the additional use of high-resolution PET-CT imaging and (2) by additional use of standard-of-care in:

    • the total study population (IDC + DCIS + ILC + NAT);
    • the IDC subgroup;
    • the DCIS subgroup;
    • the ILC subgroup;
    • the NAT subgroup.

    Measured: Perioperative (day 0).

  5. Final positive margins of the invasive component after breast-conserving surgery.

    A measure of the number of patients with final positive resection margins of the invasive component after BCS in:

    • the total study population excluding DCIS (IDC + ILC + NAT);
    • the IDC subgroup;
    • the ILC subgroup;
    • the NAT subgroup.

    Measured: Perioperative (day 0).

  6. Final positive margins of any margin after breast-conserving surgery.

    A measure of the number of patients with final positive resection margins (invasive and/or in situ component) after BCS in:

    • the total study population (IDC + DCIS + ILC + NAT);
    • the IDC subgroup;
    • the DCIS subgroup;
    • the ILC subgroup;
    • the NAT subgroup.

    Measured: Perioperative (day 0).

  7. Diagnostic performance based on the invasive component of breast cancer.

    Sensitivity, specificity, positive and negative predictive value, failure rate and, interobserver reproducibility of high-resolution PET-CT imaging based on the invasive component of:

    • the total study population excluding DCIS (IDC + ILC + NAT);
    • the IDC subgroup;
    • the ILC subgroup;
    • the NAT subgroup.

    Measured: Perioperative (day 0).

  8. Diagnostic performance based on any margin of breast cancer.

    Sensitivity, specificity, positive and negative predictive value, failure rate and, interobserver reproducibility of high-resolution PET-CT imaging based on any margin of:

    • the total study population (IDC + DCIS + ILC + NAT);
    • the IDC subgroup;
    • the DCIS subgroup;
    • the ILC subgroup;
    • the NAT subgroup.

    Measured: Perioperative (day 0).

  9. Reoperation rate.

    The number of patients that require a second or a third surgery due to positive margins at initial primary breast-conserving surgery and the type of repeat surgery (BCS or mastectomy).

    Measured: Follow-up visit (+/- week 2).

  10. Resected tissue volume.

    The volume (mm³) of resected main specimen, and possible cavity shaves after PET-CT imaging and possible cavity shaves after standard-of-care approach.

    Measured: Perioperative (day 0).

  11. Detection of malignant cells in cavity shaves and resected lymph nodes.

    A measure of success in detecting malignant cells in resected lymph nodes and cavity shaves with the adjunctive use of high-resolution PET-CT specimen imaging as detected by permanent pathology.

    Measured: Perioperative (day 0).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2021
  2. Study start17 Jun 2022
  3. Primary completion27 Mar 2025
  4. Study completion3 Apr 2025

Resources

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
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
206 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04999917
Sponsor's protocol ID
BrIMA
Acronym
BrIMA
Status last verified
Nov 2025
First submitted
2 Aug 2021
Last updated
5 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Goker M, Hahn M, Kraemer XE, Harrach H, Vanhoeij M, Vergauwen G, Van de Vijver K, De Man K, Schmidt F, Guergan S, Vergucht V, Di Micco R, Cisternino G, Gentilini OD. Specimen PET-CT Imaging for Intraoperative Margin Assessment in Early-Stage Breast Cancer: The BrIMA Nonrandomized Clinical Trial. JAMA Surg. 2026 Aug 1;161(8):785-794. doi: 10.1001/jamasurg.2026.2090.

    PubMed 42307959

Questions about this trial

What is this clinical trial studying?

A study testing high-resolution PET-CT specimen imaging. in people with Breast Cancer and Breast Cancer Invasive, run by XEOS Medical 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 11 inclusion and 10 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: finished, as of the sponsor's last update on 5 Dec 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perioperative addressing positive margins of the invasive component in IDC. (time frame: Perioperative (day 0).). 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 NCT04999917, 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 5 Dec 2025.

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