Breast CancerSMART-PETNCT07884487
Surgical Margin Assessment Using Intra-operative High-resolution PET/CT in Patients With Cancers Referred to Surgical Resection, an Exploratory Pilot Study
A study testing FDG radiotracer in people with Breast Cancer and Head and Neck Cancers, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Reoperation is often required in surgical oncology because of positive resection margins and is associated with substantial physical, psychological, and economic consequences. Reoperation may also alter or delay the initiation of adjuvant therapy, potentially increasing the risk of local or distant recurrence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Head and Neck Cancers, Lung Cancer
- What is being tested?
- FDG radiotracer
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Jul 2026to Jul 2031
- Phase
- Interventional
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient ≥ 18 years old.
- Diagnosed with one of the targeted cancers who are referred for surgical resection.
- Patients with FDG-avid cancer as evaluated by pre-operative FDG-PET/CT.
- Patients willing to participate in the study and able to give a signed informed consent form.
Who cannot join
- Non-cooperative patients.
- Pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Cliniques universitaire Saint-Luc - Université catholique de Louvain
Brussels, 1200
About this study
Reoperation is often required in surgical oncology because of positive resection margins and is associated with substantial physical, psychological, and economic consequences. Reoperation may also alter or delay the initiation of adjuvant therapy, potentially increasing the risk of local or distant recurrence. When re-resection is not feasible, a positive resection margin may necessitate additional treatment (e.g., radiation therapy or chemotherapy) that might otherwise have been avoided if clear margins had been achieved during the initial operation. Moreover, obtaining a negative margin during reoperation does not necessarily result in improved oncologic outcomes. Therefore, achieving negative margins intraoperatively is a key objective in oncologic surgery.
The AURA 10 Specimen PET/CT imaging system, a novel technology developed by a Belgian company, has recently been introduced to the market. This system enables perioperative imaging of resected tumors within approximately 10 minutes, allowing prompt assessment of surgical margins. Preliminary studies have demonstrated the potential clinical utility of this technique in various cancers, including breast, head and neck, and prostate cancers (1-5). A recent multicenter study of patients with breast cancer reported a sensitivity of 91% and a specificity of 86% for assessing surgical margin status in invasive ductal carcinoma (IDC) (4).
Read more
The aim of this study is to evaluate the clinical utility of perioperative specimen PET/CT imaging for surgical margin assessment and the feasibility of implementing this technology in routine clinical practice. The study will initially focus on breast cancer, head and neck cancer, soft tissue sarcomas, lung cancer, colorectal liver metastases, and hepatobiliary and pancreatic malignancies.
Patients will be screened for study eligibility. Those who meet the eligibility criteria will be invited to participate and provide written informed consent. On the day of the scheduled operation, patients will receive an injection of the FDG radiotracer in the Department of Nuclear Medicine approximately 1 hour before surgery. They will then be transfered by authorized personnel to the operating room. Immediately after tumor resection, the surgical specimen will be imaged using the specimen PET/CT imager (AURA 10, Xeos); this process will take approximately 10 minutes. If the surgeon decides to re-excise additional tissue, that tissue will also be imaged. In addition, all resected lymph nodes will be imaged for research purposes only.
The specimen will then be transferred to the histopathology laboratory for standard-of-care evaluation. During the operation, the results of specimen PET/CT imaging will not influence the surgeon's intraoperative decision-making. Subsequent clinical decisions will be based on the results of standard-of-care evaluations and the treating physician's clinical judgment. The final surgical margin status, as determined by the pathologist, will be collected for study purposes. Patients will receive treatment and follow-up in accordance with the standard of care, and relevant follow-up data will be collected.
- Conditions
- Breast Cancer, Head and Neck Cancers, Lung Cancer, Sarcoma, Liver Metastases From Colorectal Cancer, Gastro Intestinal Cancers
- Being tested
- FDG radiotracer
- Medical subject headings
- Breast Neoplasms, Head and Neck Neoplasms, Lung Neoplasms, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDG radiotracerDiagnostic test
Injection of FDG radiotracer around one hour befor tumor surgical resection and perfoming specimen imaging using peri-operative PET/CT machine.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Other | Single arm, open-labled Receives: Diagnostic Test: FDG radiotracer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of perioperative specimen PET/CT (AURA 10, Xeos) for detecting tumor at the surgical margin on the resected mass.
Histopathological assessment of the resected specimen will serve as the reference standard for surgical margin status. Perioperative specimen PET/CT findings will be compared with the histopathology results.
Measured: 5 years
Secondary outcomes (1)
- Outcomes predictive value of surgical margin status on specimen PET/CT, including 5-year disease-free and 5-year overall survivals. - Proportion of participants with an intraoperative change in surgical plan based on specimen PET/CT findings.
- Disease-free survival is the time from surgery to the local or distant recurrence or death from any cause.
- Overall survival is the time from surgery to death from any cause.
- A change in surgical plan is defined as performing additional margin resection ("shaving") based on specimen PET/CT findings.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start20 Jul 2026
- Primary completionJul 2031 (estimated)
- Study completionJul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884487
- Sponsor's protocol ID
- 2026/04JUI/247
- Acronym
- SMART-PET
- Status last verified
- Oct 2026
- First submitted
- 31 Jul 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to participant confidentiality and data privacy considerations.