18F-Fluciclovine (Axumin) PET/MRI accurately detected disease progression and tumor prolapse in brain metastases in patients with solid tumors and ruled out disease in non-progressors, according to findings from an ongoing study of the diagnostic performance of this imaging agent, which were presented at the
The Neuro Oncology article reported that 18F-Fluciclovine PET/MRI had a 91% diagnostic accuracy rate (95% CI, 62%-98%) for differentiating between progression and treatment-induced changes.2 The sensitivity rate was 100% (95% CI, 34%-100%; n = 2/2) with this modality, meaning that it correctly identified all true progression events. The specificity rate was 89% (95% CI, 57%-98%; n = 8/9); 1 false positive was shown.
Additionally, 18F-Fluciclovine PET/MRI had a negative predictive value of 100% (95% CI, 68%-100%), meaning that it did not miss any true progressions, translating to a false negative rate of 0% (95% CI, 0%-66%). The positive predictive value was 67% (95% CI, 21%-94%).
At SNO 2025, lead study author Marina R. Schinker, BS, presented updates that occurred after abstract submission, including 1 additional true positive report, 1 additional true negative report, and 1 event that was ruled a treatment-related change awaiting final 6-month follow-up.1 Additionally, 3 false negatives were reported in 1 patient; all were found to be invasive ductal carcinoma.
“We saw a respectable accuracy [which] gives us optimism that this is going to be a good tracer for differentiating between progression of disease and treatment-related changes, especially in comparison [with] MRI,” Schinker said in the presentation. Schinker is a client-based researcher at the University of Washington School of Medicine and Public Health in Madison.
Amino acid–based PET imaging is recommended by international working groups for the imaging of brain malignancies like brain metastases.2 However, post-treatment MRI changes can mimic disease recurrence, and conventional MRI often lacks reliable specificity.1 Misclassifying treatment-induced changes as progression of disease or vice versa can lead to unnecessary surgery, delayed treatment, or ineffective disease management.
18F-Fluciclovine is FDA approved as a diagnostic agent for PET imaging in patients with suspected prostate cancer recurrence based on elevated blood prostate-specific antigen levels following prior treatment.3 However, the imaging agent also has high tumor-to-brain contrast, which makes it an attractive candidate for imaging treated brain metastases, Schinker noted. This study is the first to examine the use of 18F-Fluciclovine after multimodal therapy in patients with brain metastases.
This trial enrolled 11 patients with a total of 14 treated brain metastases for which there was concern for progression vs treatment-induced changes that were equivocal on prior MRI.1,2 Patients in this study had previously received multimodal therapy (radiation therapy and immunotherapy, targeted therapy, and/or chemotherapy). Most patients were male (55%). Primary tumor types included lung cancer (37%), melanoma (18%), renal cell carcinoma (18%), breast cancer (18%), and kidney adenocarcinoma (9%).
Patients were confirmed to have brain metastases on MRI and then received radiotherapy and IMMT followed by bimonthly MRIs. Patients were then stratified into tumor prolapse (SUVmax of at least 4.8) vs treatment-induced change (SUVmax of less than 4.8) groups. Then, 6 lesions underwent surgical resection, and 5 lesions were clinically followed for at least 6 months.
Schinker presented a case study of a patient with a breast primary tumor and a previously treated right cerebellar metastasis who was deemed to have progression of disease during this study.1 This patient had an SUVmax of 13, underwent surgical resection, and the ruling of disease progression to recurrent carcinoma was verified pathologically.
She presented another case study of a false positive that was shown in a patient with melanoma as their primary tumor. This patient had an SUVmax that was 9.0—above the 4.8 cutoff—and was thus ruled to have progressive disease. However, metastasis resection and pathology showed treatment-related change only. The investigators hypothesized that active treatment with immunotherapy that this patient was receiving may have contributed to the heightened SUVmax that led to a false positive classification.
This ongoing trial has enrolled 16 patients so far and plans to enroll 30 total patients; however, Schinker noted that patient recruitment has been challenging due to the enrollment requirements.
“Larger cohorts will be needed to accurately characterize the operating characteristics of this tracer,” Schinker concluded.
Disclosures: Schinker had no disclosures to declare.
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Usually, when one insider buys stock, it might not be a monumental event. But when multiple insiders are buying like they did in the case of Navigator Global Investments Limited (ASX:NGI), that sends out a positive message to the company’s shareholders.
While insider transactions are not the most important thing when it comes to long-term investing, logic dictates you should pay some attention to whether insiders are buying or selling shares.
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In the last twelve months, the biggest single purchase by an insider was when Independent Non-Executive Director Lindsay Megan Wright bought AU$209k worth of shares at a price of AU$2.09 per share. We do like to see buying, but this purchase was made at well below the current price of AU$2.94. While it does suggest insiders consider the stock undervalued at lower prices, this transaction doesn’t tell us much about what they think of current prices.
While Navigator Global Investments insiders bought shares during the last year, they didn’t sell. You can see a visual depiction of insider transactions (by companies and individuals) over the last 12 months, below. By clicking on the graph below, you can see the precise details of each insider transaction!
Check out our latest analysis for Navigator Global Investments
Navigator Global Investments is not the only stock that insiders are buying. For those who like to find small cap companies at attractive valuations, this free list of growing companies with recent insider purchasing, could be just the ticket.
Over the last quarter, Navigator Global Investments insiders have spent a meaningful amount on shares. Overall, two insiders shelled out AU$240k for shares in the company — and none sold. This makes one think the business has some good points.
Another way to test the alignment between the leaders of a company and other shareholders is to look at how many shares they own. I reckon it’s a good sign if insiders own a significant number of shares in the company. Navigator Global Investments insiders own about AU$100m worth of shares. That equates to 7.0% of the company. We’ve certainly seen higher levels of insider ownership elsewhere, but these holdings are enough to suggest alignment between insiders and the other shareholders.
It is good to see recent purchasing. And the longer term insider transactions also give us confidence. Along with the high insider ownership, this analysis suggests that insiders are quite bullish about Navigator Global Investments. Nice! So these insider transactions can help us build a thesis about the stock, but it’s also worthwhile knowing the risks facing this company. For instance, we’ve identified 2 warning signs for Navigator Global Investments (1 is potentially serious) you should be aware of.
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