Background: Ovarian cancer has the highest mortality among gynecologic cancers, primarily because it typically is diagnosed at a late stage and because of the development of chemoresistance in recurrent disease. Improving outcomes in women with platinumresistant ovarian cancer is a substantial unmet need. Activation of the glucocorticoidreceptor (GR) by cortisol has been shown to suppress the apoptotic pathways used by cytotoxic agents, limiting their efficacy. Selective GR modulation may be able to counteract cortisol’s antiapoptotic effects, enhancing chemotherapy’s efficacy. A previous phase 2 study has shown that adding intermittently dosed relacorilant, a selective GR modulator, to nab-paclitaxel improved outcomes, including progression-free survival (PFS) and overall survival (OS), with minimal added toxicity, in women with recurrent platinum-resistant ovarian cancer. The ROSELLA study aims to confirm and expand on these findings in a larger population. Methods ROSELLA is a phase 3, randomized, 2-arm, open-label, global multicenter study in women with recurrent, platinum-resistant, high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer. Eligible participants have received 1 to 3 lines of prior systemic anticancer therapy, including ≥1 prior line of platinum therapy and prior treatment with bevacizumab, with documented progressive disease or intolerance to the most recent therapy. There is no biomarker-based requirement for participant selection. Participants are randomized 1:1 to receive intermittently dosed relacorilant in combination with nabpaclitaxel or nab-paclitaxel monotherapy. The study’s primary efficacy endpoint is PFS as assessed by blinded independent central review. Secondary efficacy endpoints include OS, investigator-assessed PFS, objective response rate, best overall response, duration of response, clinical benefit rate at 24 weeks, and cancer antigen 125 response. The study is also evaluating safety and patient-reported outcomes.Trial Registration: ClinicalTrials.gov Identifier: NCT05257408; European Union Drug Regulating Authorities Clinical Trials Database Identifier: 2022-000662-18

Background: Ovarian cancer has the highest mortality among gynecologic cancers, primarily because it typically is diagnosed at a late stage and because of the development of chemoresistance in recurrent disease. Improving outcomes in women with platinumresistant ovarian cancer is a substantial unmet need. Activation of the glucocorticoidreceptor (GR) by cortisol has been shown to suppress the apoptotic pathways used by cytotoxic agents, limiting their efficacy. Selective GR modulation may be able to counteract cortisol’s antiapoptotic effects, enhancing chemotherapy’s efficacy. A previous phase 2 study has shown that adding intermittently dosed relacorilant, a selective GR modulator, to nab-paclitaxel improved outcomes, including progression-free survival (PFS) and overall survival (OS), with minimal added toxicity, in women with recurrent platinum-resistant ovarian cancer. The ROSELLA study aims to confirm and expand on these findings in a larger population. Methods ROSELLA is a phase 3, randomized, 2-arm, open-label, global multicenter study in women with recurrent, platinum-resistant, high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer. Eligible participants have received 1 to 3 lines of prior systemic anticancer therapy, including ≥1 prior line of platinum therapy and prior treatment with bevacizumab, with documented progressive disease or intolerance to the most recent therapy. There is no biomarker-based requirement for participant selection. Participants are randomized 1:1 to receive intermittently dosed relacorilant in combination with nabpaclitaxel or nab-paclitaxel monotherapy. The study’s primary efficacy endpoint is PFS as assessed by blinded independent central review. Secondary efficacy endpoints include OS, investigator-assessed PFS, objective response rate, best overall response, duration of response, clinical benefit rate at 24 weeks, and cancer antigen 125 response. The study is also evaluating safety and patient-reported outcomes.Trial Registration: ClinicalTrials.gov Identifier: NCT05257408; European Union Drug Regulating Authorities Clinical Trials Database Identifier: 2022-000662-18

Objective: Diagnostic cerebral angiograms (DCAs) are widely used in neurosurgery due to their high sensitivity and specificity to diagnose and characterize pathology using ionizing radiation. Eliminating unnecessary radiation is critical to reduce risk to patients, providers, and health care staff. We investigated if reducing pulse and frame rates during routine DCAs would decrease radiation burden without compromising image quality. Methods: We performed a retrospective review of prospectively acquired data after implementing a quality improvement protocol in which pulse rate and frame rate were reduced from 15 p/s to 7.5 p/s and 7.5 f/s to 4.0 f/s respectively. Radiation doses and exposures were calculated. Two endovascular neurosurgeons reviewed randomly selected angiograms of both doses and blindly assessed their quality. Results: A total of 40 consecutive angiograms were retrospectively analyzed, 20 prior to the protocol change and 20 after. After the intervention, radiation dose, radiation per run, total exposure, and exposure per run were all significantly decreased even after adjustment for BMI (all p<0.05). On multivariable analysis, we identified a 46% decrease in total radiation dose and 39% decrease in exposure without compromising image quality or procedure time. Conclusions We demonstrated that for routine DCAs, pulse rate of 7.5 with a frame rate of 4.0 is sufficient to obtain diagnostic information without compromising image quality or elongating procedure time. In the interest of patient, provider, and health care staff safety, we strongly encourage all interventionalists to be cognizant of radiation usage to avoid unnecessary radiation exposure and consequential health risks.

Objective: We sought to investigate how priming the tube between air versus air mixed with saline ex vivo influenced suction force. We examined how priming the tube influenced peak suction force and time to achieve peak suction force between both modalities. Methods: Using a Dwyer Instruments (Dwyer Instruments Inc., Michigan City, IN, USA), INC Digitial Pressure Gauge, we were able to connect a .072 inch aspiration catheter to a rotating hemostatic valve and to aspiration tubing. We recorded suction force measured in negative inches of Mercury (inHg) over 10 iterations between having the aspiration tube primed with air alone versus air mixed with saline. A test was used to compare results between both modalities. Results: Priming the tube with air alone compared to air mixed with saline was found to have an increased average max suction force (-28.60 versus -28.20 in HG, p<0.01). We also identified a logarithmic curve of suction force across time in which time to maximal suction force was more prompt with air compared with air mixed with saline (13.8 seconds versus 21.60 seconds, p<0.01). Conclusions Priming the tube with air compared to air mixed with saline suggests that not only is increased maximal suction force achieved, but also the time required to achieve maximal suction force is less. This data suggests against priming the aspiration tubing with saline and suggests that the first pass aspiration primed with air may have the greatest suction force.