Generative AI-based low-dose digital subtraction angiography for intra-operative radiation dose reduction: a randomized controlled trial.

Digital subtraction angiography (DSA) devices guide procedures across numerous diseases, performed on more than 100,000 patients daily worldwide. However, these procedures expose patients and healthcare providers to radiation, increasing the risk of health issues. Despite many low-dose DSA imaging methods proposed, none have been prospectively clinically validated. In this study, 46,829 patients (over 5 million DSA images) from 70 centers were used to iterate our previously developed generative artificial intelligence system (named GenDSA-V2). A total of 1,068 patients (533 in intervention arm and 535 in control arm), with suspected cerebral aneurysms (n = 435), lung cancer (n = 417) or advanced liver cancer (n = 216), meeting surgical criteria, were enrolled to validate the GenDSA-V2. The primary outcome was radiation dose, while secondary outcomes included efficiency, operation time and intraoperative complications. Group assignments were blinded to patients, surgeons and investigators, while technicians were aware but not involved in data collection or analysis. The GenDSA-V2 group showed substantially reduced radiation exposure, with an air kerma (AK) of 151.3 ± 125.1 mGy compared to 457.4 ± 407.4 mGy in the standard clinical protocols (SCP) group (mean difference = -306.1 mGy, 95% confidence interval (CI) = -342.3 to -269.9, P < 0.001 for superiority) and a dose-area product (DAP) of 4009.7 ± 2767.9 μGy m versus 12531.6 ± 9145.9 μGy m (mean difference = -8521.9 μGy m, 95% CI = -9333.1 to -7710.7, P < 0.001 for superiority). Mean operation time was 33.1 ± 10.8 min in the SCP group and 34.8 ± 11.8 min in the GenDSA-V2 group (mean difference = 1.7 min, 95% CI = 0.3 to 3.1, P < 0.001 for noninferiority). Complication rates were similar (SCP = 8.1%, GenDSA-V2 = 7.5%, mean difference = -0.6%, 95% CI = -3.8% to 2.6%, P < 0.001 for noninferiority). The GenDSA system reduces radiation exposure to both physicians and patients by approximately two-thirds during DSA-guided procedures, demonstrating substantial clinical and translational value. Chinese Clinical Trial Registry: ChiCTR2400084789 .