XEOS has reported results from the BrIMA clinical study showing that its AURA 10 specimen positron emission tomography and computed tomography system improved surgeons’ ability to identify and address positive margins during breast-conserving surgery. Published in JAMA Surgery, the 148-patient study adds post-clearance clinical evidence for an imaging platform designed to place molecular and three-dimensional specimen assessment inside the operating room.
Why breast-conserving surgery still leaves a costly and unresolved margin-assessment gap
Breast-conserving surgery aims to remove a tumour while preserving as much healthy breast tissue as possible. The balance is clinically and cosmetically important, but it depends on whether the surgeon can remove the cancer with an adequate surrounding margin during the first operation.
The difficulty is that final margin status is usually confirmed through postoperative histopathology. When cancer cells are subsequently found at or too close to the edge of the removed specimen, the patient may need another procedure. Reoperation can delay additional treatment, increase cost, add anaesthetic and surgical risk, and affect the eventual cosmetic result.
Positive margins are reported in approximately 12% to 30% of breast-conserving procedures. Existing intraoperative techniques include specimen radiography, ultrasound, palpation, frozen-section analysis, cytology and cavity-shave approaches. Each has trade-offs involving accuracy, speed, staffing, tissue sampling and operating-room disruption.
XEOS is attempting to close this gap with an imaging system that combines the metabolic sensitivity of positron emission tomography with the structural detail of computed tomography. The excised specimen is scanned inside the operating room, allowing the surgeon to inspect its margins while corrective tissue removal remains possible.
The value proposition is therefore not simply better imaging. It is the possibility of moving information that normally arrives after surgery into the period when the surgeon can still act on it. That timing advantage could reduce repeat operations, but only if the images are accurate, consistently interpretable and operationally practical.
How the BrIMA study changes the evidence base for specimen PET-CT in operating rooms
BrIMA was a prospective, open-label, multicentre and nonrandomized clinical study conducted at six breast cancer centres in Belgium, Germany and Italy. It evaluated 148 women undergoing breast-conserving surgery for early-stage breast cancer, including patients with invasive ductal carcinoma, invasive lobular carcinoma, ductal carcinoma in situ and disease treated before surgery.
Participants received a low dose of fluorodeoxyglucose before surgery. After removal, the breast specimen was placed in the mobile AURA 10 scanner, which generated high-resolution PET-CT images for interpretation by the surgeon. Suspicious margins could then prompt removal of additional tissue from the corresponding area of the surgical cavity.
Among 84 patients with invasive ductal carcinoma, the intraoperative success rate for addressing the invasive margin increased from 83.3% without margin assessment to 86.9% with routine intraoperative methods and 95.2% with specimen PET-CT. When invasive and in situ components were considered together, the success rate reached 94% with PET-CT, compared with 85% using standard intraoperative assessment.
Across all study groups, the success rate increased from 76.4% without intraoperative assessment and 81.8% with routine techniques to 91.9% with specimen PET-CT. The device influenced intraoperative decisions in 26 patients, including 19 whose positive margins were not detected by the standard methods used at participating centres.
These findings suggest that whole-specimen molecular imaging can provide information that conventional assessment may miss. The system examines the entire removed specimen in three dimensions rather than relying on selected slices, surfaces or two-dimensional projections.
The study also demonstrated that the technology could be incorporated across several European hospitals rather than functioning only at the developer’s original clinical site. Multicentre performance is important for a device that depends on surgeon interpretation, radiotracer coordination and integration with operating-room routines.
However, BrIMA was not a randomized trial assigning patients to PET-CT or standard care. Every enrolled patient underwent the investigational workflow, and the comparisons were made within the study framework. The results therefore support clinical utility, but they do not provide the same level of evidence as a randomized head-to-head trial measuring actual reoperation rates between separate treatment groups.
What the headline success rates reveal and what they do not establish about reoperations
The most commercially attractive interpretation is that better intraoperative detection could reduce the number of patients returning for a second operation. The BrIMA results make that outcome plausible, but they do not prove the size of the reduction that hospitals should expect in routine practice.
Initial histopathology found positive margins in 35 of the 148 patients. After surgeons removed additional oriented tissue in response to intraoperative findings, 22 patients still had final positive margins and 15 required reoperation. This produced an overall reoperation rate of 10%.
That result sits below the higher end of commonly reported reoperation ranges, but the absence of a randomized control group prevents a direct conclusion that AURA 10 caused the difference. Surgical technique, tumour characteristics, local margin practices and the participating centres’ expertise could also influence reoperation rates.
The endpoint itself measured whether positive margins were successfully addressed rather than whether PET-CT produced superior long-term patient outcomes. BrIMA did not establish improved local recurrence, disease-free survival, cosmetic satisfaction or quality of life. Those outcomes would require larger studies and longer follow-up.
The study’s immediate significance is therefore procedural. It shows that the images can change surgical decisions and detect some margin involvement missed by routine assessment. Whether those decisions consistently translate into fewer repeat procedures, better cosmetic outcomes and lower total costs remains the next evidence requirement.
This distinction matters for hospital adoption. Surgeons may find the information useful, but procurement committees and payers will want proof that the device changes measurable outcomes rather than adding another diagnostic step to an already complex procedure.
Why low positive predictive value creates a risk of unnecessary additional tissue removal
AURA 10 produced a negative predictive value of approximately 90% when invasive and in situ disease were considered together. This suggests that a negative scan may provide relatively strong reassurance that the specimen margin is clear.
The positive predictive value was considerably lower at 42%. In practical terms, some margins identified as suspicious on PET-CT did not contain cancer when assessed through final histopathology. For invasive disease alone, the positive predictive value was 32%.
That imbalance may make the system more effective as a rule-out tool than as a definitive confirmation that a margin contains tumour. A negative result could increase confidence in ending the operation, while a positive result still requires surgical judgement.
False-positive findings have consequences. Acting on every suspicious signal could lead to removal of additional healthy tissue. Although cavity shaving may reduce the risk of a second operation, excessive tissue removal can affect breast shape, cosmetic outcome and patient satisfaction, undermining one of the primary reasons for choosing breast-conserving surgery.
The device must therefore improve sensitivity without pushing surgeons toward indiscriminate additional excision. Interpretation thresholds, training and integration with other information will be crucial. Surgeons may need to consider PET-CT findings alongside tumour orientation, specimen radiography, palpation, preoperative imaging and the expected biological behaviour of the cancer.
Performance also varied across tumour subtypes. The invasive lobular carcinoma and ductal carcinoma in situ groups were small, limiting confidence in the reported estimates. Ductal carcinoma in situ proved particularly challenging, with several positive margins remaining after additional tissue removal.
The study supports broader investigation across breast cancer subtypes, but it does not justify assuming uniform performance. Tumour biology, metabolic activity and growth patterns could affect fluorodeoxyglucose uptake and image interpretation.
How radiotracer logistics and technical failures could limit routine surgical adoption
The AURA 10 workflow begins before the specimen reaches the scanner. Patients must receive an intravenous low-dose fluorodeoxyglucose injection before tumour excision, and the timing of surgery must remain within the protocol’s imaging window.
This creates dependencies involving nuclear medicine, pharmacy or radiopharmacy access, radiation-safety procedures and operating-room scheduling. Hospitals without established positron emission tomography infrastructure may find the workflow substantially harder to implement than centres already handling radiotracers.
An invited commentary accompanying the study also raised the possibility that fluorodeoxyglucose administration could interfere with sentinel lymph-node mapping. Further operational studies may be needed to establish how the imaging protocol interacts with commonly used breast surgery procedures and radiopharmaceutical schedules.
Technical reliability is another concern. Ten participants who had received the study-specific injection did not produce interpretable specimen PET-CT images because of device-related technical issues. The trial also recorded procedural deviations, including instances in which an incorrect specimen was imaged.
These events do not erase the positive findings, but they illustrate how a sophisticated system can fail through hardware, workflow or human factors. A diagnostic platform used during surgery must work within a narrow decision window. An uninterpretable scan cannot simply be repeated days later without losing its central advantage.
The device also requires surgeons or imaging specialists to interpret three-dimensional molecular images during an active procedure. Although the study found strong agreement among trained interpreters, adoption across hospitals will depend on reproducible training, competency standards and technical support.
A scan that takes around ten minutes may fit into some surgical workflows, especially when pathology alternatives require longer turnaround. However, preparation, tracer injection, system positioning, image acquisition and interpretation must all be considered when calculating the true procedural burden.
Why AURA 10 must compete with simpler margin-assessment tools and pathology workflows
XEOS is not competing only against the absence of intraoperative margin assessment. AURA 10 enters a field containing established and emerging approaches with different cost and complexity profiles.
Frozen sections and cytology can offer strong diagnostic accuracy, but they are labour-intensive and depend on pathology resources. Specimen radiography is easier to deploy but may provide limited information about soft-tissue and microscopic margin involvement. Ultrasound can be fast and accessible, although its performance is operator-dependent.
Cavity-shave margins provide another practical strategy by removing additional tissue from the surgical cavity regardless of whether imaging identifies a specific positive margin. This approach can reduce reoperation but may increase the volume of healthy tissue removed.
Newer technologies include fluorescence imaging, optical methods, radiofrequency spectroscopy, mass spectrometry and artificial intelligence-assisted imaging. Some may be less expensive or easier to integrate than PET-CT, even if they provide different levels of anatomical and metabolic information.
AURA 10’s differentiation is its combination of whole-specimen, three-dimensional structural imaging and metabolic signal inside the operating room. The platform has received United States Food and Drug Administration clearance, meaning the commercial question is shifting from basic regulatory access to clinical adoption and evidence generation.
Its competitive weakness is complexity. A hospital may appreciate richer imaging but still prefer a simpler method if the alternative produces acceptable outcomes at lower cost. The relevant comparison will not be whether PET-CT detects more abnormalities in isolation, but whether the incremental information justifies the equipment, tracer and staffing requirements.
What hospitals and payers will need before specimen PET-CT becomes a scalable platform
Health systems will first need a transparent economic case. Device purchase or leasing costs, maintenance, consumables, tracer supply, training and operating-room time must be compared with the cost of repeat surgery, additional pathology, delayed treatment and patient recovery.
The strongest commercial case may emerge in high-volume breast centres with elevated reoperation rates or existing nuclear medicine infrastructure. These hospitals may be able to spread fixed costs across more procedures and convert avoided repeat operations into measurable savings.
Smaller hospitals may face a different calculation. Even if the device improves intraoperative decisions, low procedural volume could make the economics unattractive. Referral networks or shared service models may be necessary if specimen PET-CT remains concentrated in specialist centres.
Payers will also need clarity on reimbursement. Without a dedicated payment pathway, hospitals may be reluctant to absorb the additional imaging expense, particularly when the financial benefit of avoiding a reoperation may accrue to a different part of the healthcare system.
Future trials should randomize patients to specimen PET-CT and an appropriate standard-care strategy, with reoperation as a prospective endpoint. Cosmetic outcomes, patient-reported quality of life, total treatment cost and time to adjuvant therapy would strengthen the value proposition.
Evidence from more diverse patient populations is also required. Every participant included in the BrIMA analysis was White, limiting confidence in generalizability. Larger studies should include broader racial and geographic representation, as well as more patients with lobular carcinoma, ductal carcinoma in situ and treatment before surgery.
Could specimen PET-CT expand beyond breast surgery or remain a specialist-centre technology?
The broader opportunity for XEOS lies in applying specimen PET-CT to other solid tumours where margin status influences recurrence, reoperation or the need for additional treatment. Potential applications could involve prostate, head and neck, thyroid, pancreatic and other oncologic procedures, depending on tracer suitability and tumour biology.
A platform used across several surgical specialties would improve the economic case because hospitals could distribute equipment costs across a larger procedural base. It would also position AURA 10 as operating-room molecular imaging infrastructure rather than a device limited to breast surgery.
Expansion will require indication-specific evidence. Different cancers have different tracers, margin definitions, specimen sizes and surgical workflows. Success in invasive ductal carcinoma cannot automatically be transferred to every tumour type.
BrIMA nevertheless moves specimen PET-CT beyond technical feasibility. It shows that intraoperative molecular imaging can identify clinically relevant margins that routine methods miss and can influence surgery while the patient remains in the operating room.
The unresolved issue is whether that additional information produces enough benefit to justify the system’s complexity. Low positive predictive value, nonrandomized evidence, technical failures and radiotracer logistics argue against immediate universal adoption.
XEOS has demonstrated that AURA 10 can change what surgeons see. The next challenge is proving that those additional images consistently change what matters most, including repeat surgery, preservation of healthy tissue, patient experience and total healthcare cost.
