Quantification of Activity Lost to Delivery-System Residual and Decay in Yttrium-90 Radioembolization.

PURPOSE: To measure the decay activity loss and delivery system residual activity loss of yttrium-90 (Y90) radioembolization treatments across resin and glass microsphere activities. MATERIALS AND METHODS: For Y90 administrations between December 2009 and June 2017 at the study institution, the prescribed activity, prepared activity, and delivered activity were recorded. Six hundred sixty-two administrations were reviewed-345 glass (0.21-8.52 GBq) and 317 resin (0.18-3.28 GBq). Twenty-five patients (all resin) were excluded for arterial stasis or catheter clogging. The percentage and actual losses of activity lost to decay and to delivery system residual were calculated for glass and resin microspheres. RESULTS: The median time between activity premeasurement and administration was 2.20 hours, resulting in a median activity lost to decay of 0.030 GBq or 2.35%, with no significant difference observed between glass and resin despite differences in preparation (P = .0697). Resin showed significantly higher activity lost to delivery system residual than glass (0.039 GBq vs 0.010 GBq, 3.01% vs 0.61%, P < .001). The percent activity lost to residual varied with activity prepared, with a maximum of 20.1% and 16.2% for the smallest activities of resin and glass, respectively. CONCLUSIONS: Residual activity loss differs between glass and resin microspheres. For resin microspheres in particular, percent residual activity loss increases with lower prepared activities. Protocols for activity calculation and preparation, patient dosimetry, and regulatory compliance must take these losses into consideration prospectively.

Recommendations for radioembolisation after liver surgery using yttrium-90 resin microspheres based on a survey of an international expert panel.

INTRODUCTION: Guidelines on how to adjust activity in patients with a history of liver surgery who are undergoing yttrium-90 radioembolisation (90Y-RE) are lacking. The aim was to study the variability in activity prescription in these patients, between centres with extensive experience using resin microspheres 90Y-RE, and to draw recommendations on activity prescription based on an expert consensus. METHODS: The variability in activity prescription between centres was investigated by a survey of international experts in the field of 90Y-RE. Six representative post-surgical patients (i.e. comparable activity prescription, different outcome) were selected. Information on patients' disease characteristics and data needed for activity calculation was presented to the expert panel. Reported was the used method for activity prescription and whether, how and why activity reduction was found indicated. RESULTS: Ten experts took part in the survey. Recommendations on activity reduction were highly variable between the expert panel. The median intra-patient range was 44 Gy (range 18-55 Gy). Reductions in prescribed activity were recommended in 68% of the cases. In consensus, a maximum DTarget of 50 Gy was recommended. CONCLUSION: With a current lack of guidelines, large variability in activity prescription in post-surgical patients undergoing 90Y-RE exists. In consensus, DTarget ≤50 Gy is recommended. KEY POINTS: • BSA method does not account for a decreased remnant liver volume after surgery. • In post-surgical patients, a volume-based activity determination method is recommended. • In post-surgical patients, a mean D Target of ≤ 50Gy should be aimed for.

Yttrium-90 Radioembolization with Resin Microspheres without Routine Embolization of the Gastroduodenal Artery.

PURPOSE: To evaluate safety of resin microsphere radioembolization (RE) without prophylactic embolization of the gastroduodenal artery (GDA). MATERIALS AND METHODS: Between July 2013 and April 2015, all patients undergoing RE with resin microspheres for liver-dominant metastatic disease were treated without routine embolization of the GDA. Selective embolization of distal hepaticoenteric vessels was performed if identified by digital subtraction angiography, cone-beam computed tomography, or technetium-99m macroaggregated albumin scintigraphy. Resin microspheres were administered using 5% dextrose flush distal to the origin of the GDA in lobar or segmental fashion, with judicious use of an antireflux microcatheter in recognized high-risk situations. Gastrointestinal toxicity was evaluated by the performing physician for at least 3 months. RESULTS: RE with resin microspheres was performed in 62 patients undergoing 69 treatments. During planning angiography, embolization of 0 or 1 vessel (median, 1; range, 0-4) was performed in 86% of patients, most commonly the right gastric and supraduodenal arteries. Prophylactic embolization of the GDA was performed in only 2 patients (3%). In 6 treatments (9%), adjunctive embolization was required immediately before RE, and an antireflux microcatheter was used in 14% of treatments. Clinical follow-up was available in 60 of 62 patients (median, 134 d; range, 15-582 d). No signs or symptoms of gastric or duodenal ulceration were observed. CONCLUSIONS: RE using resin microspheres without embolization of the GDA can be performed safely.

The Role of Dual-Phase Cone-Beam CT in Predicting Short-Term Response after Transarterial Chemoembolization for Hepatocellular Carcinoma.

PURPOSE: To identify computational and qualitative features derived from dual-phase cone-beam CT that predict short-term response in patients undergoing transarterial chemoembolization for hepatocellular carcinoma (HCC). MATERIALS AND METHODS: This retrospective study included 43 patients with 59 HCCs. Six features were extracted, including intensity of tumor enhancement on both phases and characteristics of the corona on the washout phase. Short-term response was evaluated by modified Response Evaluation Criteria in Solid Tumors on follow-up imaging, and extracted features were correlated to response using univariate and multivariate analyses. RESULTS: Univariate and multivariate analyses did not reveal a correlation between absolute and relative tumor enhancement characteristics on either phase with response (arterial P = .21; washout P = .40; ∆ P = .90). On multivariate analysis of qualitative characteristics, the presence of a diffuse corona was an independent predictor of incomplete response (P = .038) and decreased the odds ratio of objective response by half regardless of tumor size. CONCLUSIONS: Computational features extracted from contrast-enhanced dual-phase cone-beam CT are not prognostic of response to transarterial chemoembolization in patients with HCC. HCCs that demonstrate a diffuse, patchy corona have reduced odds of achieving complete response after transarterial chemoembolization and should be considered for additional treatment with an alternative modality.

Superselective Chemoembolization of HCC: Comparison of Short-term Safety and Efficacy between Drug-eluting LC Beads, QuadraSpheres, and Conventional Ethiodized Oil Emulsion.

PURPOSE: To study the comparative short-term safety and efficacy of transcatheter arterial chemoembolization (TACE) with drug-eluting LC Beads loaded with doxorubicin (DEBDOX), doxorubicin-eluting QuadraSpheres (hqTACE), and conventional TACE using ethiodized oil for superselective C-arm computed tomography (CT)-guided treatment of hepatocellular carcinoma (HCC) after the onset of drug shortages. MATERIALS AND METHODS: From March 2010 to March 2011, 166 patients with HCC were treated with 232 superselective TACE procedures using C-arm cone-beam CT at one institution. Patients underwent treatment depending on the availability of materials after the onset of drug shortages. Conventional TACE with doxorubicin, cisplatin, and Ethiodol was performed for 159 procedures, DEBDOX TACE was performed for 47, and hqTACE was performed for 26. Toxicity and objective response were compared at 3 months after treatment. Data were stratified for the high-risk population (Child-Pugh class B, performance status 1, bilobar disease, and/or post-resection recurrence) and initial versus repeat treatment. Kruskal-Wallis H test, Mann-Whitney U test, and Fisher exact test were used to compare the groups, with Bonferroni correction where needed. RESULTS: Whole liver response rates trended higher for conventional TACE (conventional TACE, 65.4%; DEBDOX, 63.8%; hqTACE, 53.8%) (P = .085). Only minor trends for differences in toxicity were observed between the three groups. Low-risk patients had higher whole liver (P = .001) and treated lesion (P = .007) response rates when treated with conventional TACE, but no significant differences were seen for DEBDOX and hqTACE. Treatment-naive patients also had higher whole liver (P = .012) and treated lesion (P = .056) response rates. No advantages for drug-eluting microspheres were found. CONCLUSION: Within statistical power limitations, overall toxicity and efficacy were equivalent in patients treated with LC Beads, QuadraSpheres, or ethiodized oil emulsions, including in high-risk patients, when performed superselectively with cone-beam C-arm CT guidance.

Fusion dual-tracer SPECT-based hepatic dosimetry predicts outcome after radioembolization for a wide range of tumour cell types.

PURPOSE: Fusion dual-tracer SPECT imaging enables physiological rather than morphological voxel-based partitioning and dosimetry for (90)Y hepatic radioembolization (RE). We evaluated its prognostic value in a large heterogeneous cohort of patients with extensive hepatic malignancy. METHODS: A total of 122 patients with primary or secondary liver malignancy (18 different cell types) underwent SPECT imaging after intraarterial injection of (99m)Tc macroaggregated albumin (TcMAA) as a simulation of subsequent (90)Y microsphere distribution, followed by administration of an excess of intravenous (99m)Tc-labelled sulphur colloid (TcSC) as a biomarker for functional liver, and a second SPECT scan. TcMAA distribution was used to estimate (90)Y radiation absorbed dose in tumour (D T) and in functional liver. Laboratory and clinical follow-up were recorded for 12 weeks after RE, and radiographic responses according to (m)RECIST were evaluated at 3 and 6 months. Dose-response relationships were determined for efficacy and toxicity. RESULTS: Patients were treated with a median of 1.73 GBq activity of resin microspheres (98 patients) or glass microspheres (24 patients), in a whole-liver approach (97 patients) or a lobar approach (25 patients). The objective response rate was 41% at 3 months and 48% at 6 months. Response was correlated with D T (P < 0.01). Median overall survival was 10.1 months (95% confidence interval 7.4 - 12.8 months). Responders lived for 36.0 months compared to 8.7 months for nonresponders (P < 0.01). Stratified for tumour cell type, D T was independently associated with survival (P < 0.01). Absorbed dose in functional liver was correlated with toxicity grade change (P < 0.05) and RE-induced liver disease (P < 0.05). CONCLUSION: Fusion dual-tracer SPECT imaging offers a physiology-based functional imaging tool to predict efficacy and toxicity of RE. This technique can be refined to define dosing thresholds for specific tumour types and treatments, but appears generally predictive even in a heterogeneous cohort.

Emergent salvage direct intrahepatic portocaval shunt procedure for acute variceal hemorrhage.

PURPOSE: To review the safety and effectiveness of direct intrahepatic portocaval shunt (DIPS) creation with variceal embolization for acute variceal hemorrhage after a failed transjugular intrahepatic portosystemic shunt (TIPS) creation attempt or in patients with prohibitive anatomy. MATERIALS AND METHODS: Transjugular intrahepatic portosystemic shunt and DIPS procedures performed for variceal hemorrhage between January 2008 and July 2014 were reviewed. The default procedure was TIPS creation, with DIPS creation reserved for patients with unfavorable anatomy or who had technically unsuccessful TIPS creation. Thirteen patients underwent DIPS creation (mean age, 60 y ± 12; Child-Pugh class A/B/C, 8%/62%/30%; Model for End-stage Liver Disease score, 15 ± 5; range, 8-26) and 117 underwent TIPS creation. Four patients underwent a TIPS attempt and were converted to DIPS creation upon technical failure; 9 were treated primarily with DIPS creation because of preprocedural imaging revealing unfavorable anatomy (intrahepatic portal thrombosis, n = 2; venous distortion from prior hepatic resections, n = 2; severely angulated hepatic veins, n = 5). RESULTS: Direct intrahepatic portocaval shunt creation with variceal embolization (six gastric or esophageal; seven stomal, duodenal, or rectal) was successful in all patients; 11 also had concomitant variceal sclerotherapy. Mean DIPS procedure time was less than 2 hours. There was 1 major procedural complication. During a mean follow-up of 13.0 months ± 15.5, 1 patient developed DIPS thrombosis and recurrent hemorrhage; 1 patient underwent successful transplantation. Two deaths were observed within 30 days, neither associated with recurrent hemorrhage. CONCLUSIONS: Direct intrahepatic portocaval shunt creation appears to be a safe, expedient, and effective treatment for patients with acute variceal hemorrhage who are poor anatomic candidates for TIPS creation or who have undergone unsuccessful TIPS creation attempts.

Optimal imaging surveillance schedules after liver-directed therapy for hepatocellular carcinoma.

PURPOSE: To optimize surveillance schedules for the detection of recurrent hepatocellular carcinoma (HCC) after liver-directed therapy. MATERIALS AND METHODS: New methods have emerged that allow quantitative analysis and optimization of surveillance schedules for diseases with substantial rates of recurrence such as HCC. These methods were applied to 1,766 consecutive chemoembolization, radioembolization, and radiofrequency ablation procedures performed on 910 patients between 2006 and 2011. Computed tomography or magnetic resonance imaging performed just before repeat therapy was set as the time of "recurrence," which included residual and locally recurrent tumor as well as new liver tumors. Time-to-recurrence distribution was estimated by Kaplan-Meier method. Average diagnostic delay (time between recurrence and detection) was calculated for each proposed surveillance schedule using the time-to-recurrence distribution. An optimized surveillance schedule could then be derived to minimize the average diagnostic delay. RESULTS: Recurrence is 6.5 times more likely in the first year after treatment than in the second. Therefore, screening should be much more frequent in the first year. For eight time points in the first 2 years of follow-up, the optimal schedule is 2, 4, 6, 8, 11, 14, 18, and 24 months. This schedule reduces diagnostic delay compared with published schedules and is cost-effective. CONCLUSIONS: The calculated optimal surveillance schedules include shorter-interval follow-up when there is a higher probability of recurrence and longer-interval follow-up when there is a lower probability. Cost can be optimized for a specified acceptable diagnostic delay or diagnostic delay can be optimized within a specified acceptable cost.

Management of High Hepatopulmonary Shunting in Patients Undergoing Hepatic Radioembolization.

PURPOSE: To review the safety of hepatic radioembolization (RE) in patients with high (≥ 10%) hepatopulmonary shunt fraction (HPSF) using various prophylactic techniques. MATERIALS AND METHODS: A review was conducted of 409 patients who underwent technetium 99m-labeled macroaggregated albumin scintigraphy before planned RE. Estimated pulmonary absorbed radiation doses based on scintigraphy and hepatic administered activity were calculated. Outcomes from dose reductions and adjunctive catheter-based prophylactic techniques used to reduce lung exposure were assessed. RESULTS: There were 80 patients with HPSF ≥ 10% who received RE treatment (41 resin microspheres for metastases, 39 glass microspheres for hepatocellular carcinoma). Resin microspheres were used in 17 patients according to consensus guideline-recommended dose reduction; 38 patients received no dose reduction because the expected lung dose was < 30 Gy. Prophylactic techniques were used in 25 patients (with expected lung dose ≤ 74 Gy), including hepatic vein balloon occlusion, variceal embolization, or bland arterial embolization before, during, or after RE delivery. Repeated scintigraphy after prophylactic techniques to reduce HPSF in seven patients demonstrated a median change of -40% (range, +32 to -69%). Delayed pneumonitis developed in two patients, possibly related to radiation recall after chemoembolization. Response was lower in patients treated with resin spheres with dose reduction, with an objective response rate of 13% and disease control rate of 47% compared with 56% and 94%, respectively, without dose reduction (P = .023, P = .006). CONCLUSIONS: Dose reduction recommendations for HPSF may compromise efficacy. Excessive shunting can be reduced by prophylactic catheter-based techniques, which may improve the safety of performing RE in patients with high HPSF.

Watershed Hepatocellular Carcinomas: The Risk of Incomplete Response following Transhepatic Arterial Chemoembolization.

PURPOSE: Hepatocellular carcinomas (HCCs) bridging two or more Couinaud-Bismuth segments of the liver ("watershed tumors") can recruit multiple segmental arteries. The primary hypothesis of this study was that fewer watershed tumors show complete response (CR) after chemoembolization, with shorter time to local recurrence. Secondary analysis on the impact on transplantation eligibility in the presence of progressive disease was also performed. MATERIALS AND METHODS: A total of 155 transplantation-eligible patients whose HCC met Milan criteria (watershed, n = 83; nonwatershed, n = 72) and was treated with chemoembolization were included. Cone-beam computed tomography (CT) was used for guidance and for confirmation of circumferential uptake. Local response to chemoembolization per modified Response Evaluation Criteria In Solid Tumors and local disease-free survival (DFS) for the index tumor were calculated. Differences were assessed by univariate and multivariate analyses. RESULTS: CR after a single of chemoembolization was observed in 55.4% of watershed tumors and in 72.2% of nonwatershed tumors (P = .045). Estimated DFS intervals were 151 days (95% confidence interval [CI], 93-245 d) and 336 days (95% CI, 231-747 d; P = .040) in the watershed and nonwatershed groups, respectively. Worse DFS was observed with a Model for End-Stage Liver Disease score > 20 (P = .0001), higher Child-Pugh-Turcotte score (P = .049), and watershed location (P = .040). Waiting list drop-off rates were statistically similar between groups. CONCLUSIONS: Hepatocellular carcinomas located in the watershed region of the liver have a poorer response to chemoembolization than those located elsewhere. These tumors are associated with worse DFS and require additional treatments to maintain transplantation eligibility per Milan criteria. Cone-beam CT can identify crossover supply and confirm complete geographic drug uptake, possibly reducing (but not eliminating) the risk of incomplete response.

Limitations of body surface area-based activity calculation for radioembolization of hepatic metastases in colorectal cancer.

PURPOSE: To calculate absorbed radiation doses in patients treated with resin microspheres prescribed by the body surface area (BSA) method and to analyze dose-response and toxicity relationships. MATERIALS AND METHODS: A retrospective review was performed of 45 patients with colorectal carcinoma metastases who received single-session whole-liver resin microsphere radioembolization. Prescribed treatment activity was calculated using the BSA method. Liver volumes and whole-liver absorbed doses (D(WL)) were calculated. D(WL) was correlated with toxicity and radiographic and biochemical response. RESULTS: The standard BSA-based administered activity (range, 0.85-2.58 GBq) did not correlate with D(WL) (mean, 50.4 Gy; range, 29.8-74.7 Gy; r = -0.037; P = .809) because liver weight was highly variable (mean, 1.89 kg; range, 0.94-3.42 kg) and strongly correlated with D(WL) (r = -0.724; P < .001) but was not accounted for in the BSA method. Patients with larger livers were relatively underdosed, and patients with smaller livers were relatively overdosed. Patients who received D(WL) > 50 Gy experienced more toxicity and adverse events (> grade 2 liver toxicity, 46% vs 17%; P < .05) but also responded better to the treatment than patients who received D(WL)< 50 Gy (disease control, 88% vs 24%; P < .01). CONCLUSIONS: Using the standard BSA formula, the administered activity did not correlate with D(WL). Based on this short-term follow-up after salvage therapy in patients with late stage metastatic colorectal carcinoma, dose-response and dose-toxicity relationships support using a protocol based on liver volume rather than BSA to prescribe the administered activity.

Pulmonary interstitial lymphography: A prospective trial with potential impact on stereotactic ablative radiotherapy planning for early-stage lung cancer.

This prospective feasibility trial investigated pulmonary interstitial lymphography to identify thoracic primary nodal drainage (PND). A post-hoc analysis of nodal recurrences was compared with PND for patients with early-stage lung cancer; larger studies are needed to establish correlation. Exploratory PND-inclusive stereotactic ablative radiotherapy plans were assessed for dosimetric feasibility.

Carbon dioxide contrast enhancement for C-arm CT utility for treatment planning during hepatic embolization procedures.

A pilot study was performed to evaluate the use of carbon dioxide (CO2) as a contrast medium for C-arm computed tomography (CT). C-arm CT using CO2 was performed during embolization procedures in12 patients with hepatic malignancies and severe iodine allergy or high risk for nephrotoxicity. C-arm CT using gadolinium or iodinated contrast medium was performed for comparison. Of segmental arteries identified by conventional contrast enhancement, 96% were also seen with CO2 enhancement, but subsegmental arteries were not reliably depicted. CO2 enhancement identified 60% of tumors. Small, hypovascular, and infiltrative tumors were difficult to detect. CO2 is a promising alternative intraarterial contrast agent for C-arm CT.

Prophylactic topically applied ice to prevent cutaneous complications of nontarget chemoembolization and radioembolization.

Cutaneous complications can result from nontarget deposition during transcatheter arterial chemoembolization or radioembolization. Liver tumors may receive blood supply from parasitized extrahepatic arteries (EHAs) that also perfuse skin or from hepatic arteries located near the origin of the falciform artery (FA), which perfuses the anterior abdominal wall. To vasoconstrict cutaneous vasculature and prevent nontarget deposition, ice packs were topically applied to at-risk skin in nine chemoembolization treatments performed via 14 parasitized EHAs, seven chemoembolization treatments near the FA origin, and five radioembolization treatments in cases in which the FA could not be prophylactically coil-embolized. No postprocedural cutaneous complications were encountered.

Intravascular ultrasound-guided mesocaval shunt creation in patients with portal or mesenteric venous occlusion.

Extrahepatic mesocaval shunts were successfully created in three patients with refractory variceal hemorrhage, complete portal vein or superior mesenteric vein occlusion, and contraindications to shunt surgery. The use of intravascular ultrasound guidance and covered stents allowed safe and effective transvenous shunt creation without the necessity of percutaneous transabdominal mesenteric venous puncture.

Preoperative embolization of replaced right hepatic artery prior to pancreaticoduodenectomy.

Aberrancy of the hepatic arterial anatomy is common. Because of its course directly adjacent to the head of the pancreas, a replaced right hepatic artery (RHA) is vulnerable to invasion by peri-pancreatic malignancies. Division of the RHA at the time of pancreaticoduodenectomy, however, may result in hepatic infarction and/or bilioenteric anastomotic complications. We report two cases of patients undergoing preoperative embolization of tumor encased replaced RHAs to allow for sufficient collateralization prior to pancreaticoduodenectomy.

Yttrium-90 radioembolization of renal cell carcinoma metastatic to the liver.

PURPOSE: To investigate the safety and efficacy of yttrium-90 ((90)Y) hepatic radioembolization treatment of patients with liver-dominant metastatic renal cell carcinoma (RCC) refractory to immunotherapy and targeted therapies. MATERIALS AND METHODS: Between March 2006 and December 2010, six patients with metastatic RCC underwent eight radioembolization treatments with (90)Y-labeled resin microspheres for unresectable liver-dominant metastases. All six patients had previous hepatic tumor progression despite targeted therapies or immunotherapies. All had bilobar disease and required whole-liver treatment. Clinical and biochemical toxicities were recorded, and tumor response was assessed every 2-3 months after treatment by cross-sectional imaging. RESULTS: The median dose delivered was 1.89 Gbq (range 0.41-2.03 Gbq). Grade 1 and 2 toxicities were noted in all patients, primarily fatigue. Follow-up imaging was available for five patients. In follow-up periods from 2-64 months (mean 25 months), three patients showed complete responses, and 1 patient showed a partial response by standard imaging criteria, and these patients are alive at 64 months, 55 months, 17 months, and 7 months after treatment. Two patients with rapid progression of disease died within 2 months of treatment, although hepatic malignancy or failure was not the cause of death in either patient. CONCLUSIONS: (90)Y radioembolization is a promising option for liver-dominant metastatic RCC with potential for providing long-term survival in patients refractory to or intolerant of targeted therapies.

Percutaneous cholecystostomy for acute cholecystitis: ten-year experience.

PURPOSE: To review the clinical course of patients with acute cholecystitis treated by percutaneous cholecystostomy, and to identify risk factors retrospectively that predict outcome. MATERIALS AND METHODS: A total of 106 patients diagnosed with acute cholecystitis were treated by percutaneous cholecystostomy during a 10-year period. Seventy-one (67%) presented to the emergency department (ED) specifically for acute cholecystitis, and 35 (23%) were inpatients previously admitted for other conditions. Outcomes of the two groups were compared with respect to severity of illness, leukocytosis, bile culture, liver function tests, imaging features, time intervals from onset of symptoms to medical and percutaneous intervention, and whether surgical cholecystectomy was later performed. RESULTS: Overall, 72 patients (68%) showed an improvement clinically, whereas 34 (32%) showed no improvement or a clinically worsened condition after cholecystostomy. Patients who presented to the ED primarily with acute cholecystitis fared better (84% of patients showed improvement) than inpatients (34% showed improvement; P < .0001). Gallstones were identified in 54% of patients who presented to the ED, whereas acalculous cholecystitis was more commonly diagnosed in inpatients (54%). Patients with sepsis had worse outcomes overall (P < .0001). Bacterial bile cultures were analyzed in 95% of patients and showed positive results in 52%, with no overall effect on outcome. There was no correlation between the time of onset of symptoms until antibiotic therapy or cholecystostomy in either group. Long-term outcomes for both groups were better for those who later underwent cholecystectomy (P < .0001). CONCLUSIONS: Outcomes after percutaneous cholecystostomy for acute cholecystitis are better when the disease is primary and not precipitated by concurrent illness.

Applying a structured innovation process to interventional radiology: a single-center experience.

PURPOSE: To determine the feasibility and efficacy of applying an established innovation process to an active academic interventional radiology (IR) practice. MATERIALS AND METHODS: The Stanford Biodesign Medical Technology Innovation Process was used as the innovation template. Over a 4-month period, seven IR faculty and four IR fellow physicians recorded observations. These observations were converted into need statements. One particular need relating to gastrostomy tubes was diligently screened and was the subject of a single formal brainstorming session. RESULTS: Investigators collected 82 observations, 34 by faculty and 48 by fellows. The categories that generated the most observations were enteral feeding (n = 9, 11%), biopsy (n = 8, 10%), chest tubes (n = 6, 7%), chemoembolization and radioembolization (n = 6, 7%), and biliary interventions (n = 5, 6%). The output from the screening on the gastrostomy tube need was a specification sheet that served as a guidance document for the subsequent brainstorming session. The brainstorming session produced 10 concepts under three separate categories. CONCLUSIONS: This formalized innovation process generated numerous observations and ultimately 10 concepts to potentially to solve a significant clinical need, suggesting that a structured process can help guide an IR practice interested in medical innovation.