TY - JOUR
T1 - Evaluation of a Novel Absorbable Radiopaque Hydrogel in Patients Undergoing Image Guided Radiation Therapy for Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma
AU - Rao, Avani Dholakia
AU - Shin, Eun Ji
AU - Meyer, Jeffrey
AU - Thompson, Elizabeth L.
AU - Fu, Wei
AU - Hu, Chen
AU - Fishman, Elliot K.
AU - Weiss, Matthew
AU - Wolfgang, Christopher
AU - Burkhart, Richard
AU - He, Jin
AU - Kerdsirichairat, Tossapol
AU - Herman, Joseph M.
AU - Ding, Kai
AU - Narang, Amol
N1 - Funding Information:
Sources of support: Augmenix (Bedford, MA) provided a research grant to fund the clinical trial reported in this article; however, data were collected, analyzed, and reported independently from the sponsor. Research reported in this publication was supported in part by the National Cancer Institute of the National Institutes of Health under Award Number R37CA229417. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Funding Information:
Sources of support: Augmenix (Bedford, MA) provided a research grant to fund the clinical trial reported in this article; however, data were collected, analyzed, and reported independently from the sponsor. Research reported in this publication was supported in part by the National Cancer Institute of the National Institutes of Health under Award Number R37CA229417. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.Disclosures: Dr Rao reports grants from Augmenix (related to the submitted work), during the conduct of the study. Dr Shin reports grants from National Cancer Institute and Augmenix (related to the submitted work), during the conduct of the study. Dr Meyer reports grants from Augmenix (related to the submitted work), during the conduct of the study; other from UpToDate, Inc, outside the submitted work. Dr Hu reports grants from National Cancer Institute, grants from American College of Radiology, and personal fees from Merck & Co, outside the submitted work. Dr Herman reports grants, personal fees, other from Augmenix, and personal fees from Boston Scientific, during the conduct of the study (related to the submitted work); personal fees from Bristol-Meyers Squibb, grants, personal fees, and other from Astra-Zeneca, personal fees and other from Medtronic, grants from Oncosil, and grants from Galera, outside the submitted work. Dr Ding reports grants from National Cancer Institute and Augmenix (related to the submitted work), during the conduct of the study. Dr Narang reports grants from National Cancer Institute and Augmenix (related to the submitted work), during the conduct of the study. Drs Thompson, Fishman, Weiss, Wolfgang, Burkhart, He, Kerdsirichariat, and Wei Fu have nothing to disclose.
Funding Information:
Disclosures: Dr Rao reports grants from Augmenix (related to the submitted work), during the conduct of the study. Dr Shin reports grants from National Cancer Institute and Augmenix (related to the submitted work), during the conduct of the study. Dr Meyer reports grants from Augmenix (related to the submitted work), during the conduct of the study; other from UpToDate, Inc, outside the submitted work. Dr Hu reports grants from National Cancer Institute , grants from American College of Radiology , and personal fees from Merck & Co, outside the submitted work. Dr Herman reports grants, personal fees, other from Augmenix, and personal fees from Boston Scientific, during the conduct of the study (related to the submitted work); personal fees from Bristol-Meyers Squibb, grants, personal fees, and other from Astra-Zeneca, personal fees and other from Medtronic, grants from Oncosil, and grants from Galera, outside the submitted work. Dr Ding reports grants from National Cancer Institute and Augmenix (related to the submitted work), during the conduct of the study. Dr Narang reports grants from National Cancer Institute and Augmenix (related to the submitted work), during the conduct of the study. Drs Thompson, Fishman, Weiss, Wolfgang, Burkhart, He, Kerdsirichariat, and Wei Fu have nothing to disclose.
Publisher Copyright:
© 2020 American Society for Radiation Oncology
PY - 2020/11/1
Y1 - 2020/11/1
N2 - Purpose: We assessed the feasibility and safety of placing a radiopaque hydrogel in the pancreaticoduodenal groove via endoscopic ultrasound guidance in patients with borderline resectable/locally advanced pancreatic cancer (BR/LAPC). Methods and Materials: Hydrogel injections were done at time of fiducial placement to form blebs in the pancreaticoduodenal groove. Patients subsequently underwent simulation computed tomography (sim-CT) followed by hypofractionated stereotactic body radiotherapy (SBRT; 33 Gy in 5 fractions). Four to 8 weeks after SBRT, patients underwent CT re-evaluation for surgical candidacy and assessment of hydrogel location and size. Hydrogel placement was considered successful if identified in the pancreaticoduodenal groove on sim-CT scan. Stability was evaluated using equivalence testing analyses, with a null hypothesis of the presence of a ≥20% mean percentage change in volume and ≥2 mm change in the median and mean interbleb surface distance with a P value <.05 required to reject the null hypothesis and conclude equivalence. For patients undergoing pancreaticoduodenectomy, hydrogel sites were histologically examined for location and local inflammatory reactions. Results: Hydrogel placement was successful in 6 of the 6 evaluable patients. The average changes in median and mean interbleb distances were −0.43 mm and −0.35 mm, respectively, with P < .05. The average change in volume from sim-CT to post-SBRT CT was −1.0%, with P < .05. One patient experienced grade 3 nausea after fiducial/hydrogel placement, with no other adverse events to date. Conclusions: These data demonstrate feasibility and safety of injecting a hydrogel marker in the pancreaticoduodenal groove in patients with BR/LAPC and set the stage for a follow-up clinical trial to place hydrogel as a spacer between the pancreatic tumor and dose-limiting, radiosensitive duodenum.
AB - Purpose: We assessed the feasibility and safety of placing a radiopaque hydrogel in the pancreaticoduodenal groove via endoscopic ultrasound guidance in patients with borderline resectable/locally advanced pancreatic cancer (BR/LAPC). Methods and Materials: Hydrogel injections were done at time of fiducial placement to form blebs in the pancreaticoduodenal groove. Patients subsequently underwent simulation computed tomography (sim-CT) followed by hypofractionated stereotactic body radiotherapy (SBRT; 33 Gy in 5 fractions). Four to 8 weeks after SBRT, patients underwent CT re-evaluation for surgical candidacy and assessment of hydrogel location and size. Hydrogel placement was considered successful if identified in the pancreaticoduodenal groove on sim-CT scan. Stability was evaluated using equivalence testing analyses, with a null hypothesis of the presence of a ≥20% mean percentage change in volume and ≥2 mm change in the median and mean interbleb surface distance with a P value <.05 required to reject the null hypothesis and conclude equivalence. For patients undergoing pancreaticoduodenectomy, hydrogel sites were histologically examined for location and local inflammatory reactions. Results: Hydrogel placement was successful in 6 of the 6 evaluable patients. The average changes in median and mean interbleb distances were −0.43 mm and −0.35 mm, respectively, with P < .05. The average change in volume from sim-CT to post-SBRT CT was −1.0%, with P < .05. One patient experienced grade 3 nausea after fiducial/hydrogel placement, with no other adverse events to date. Conclusions: These data demonstrate feasibility and safety of injecting a hydrogel marker in the pancreaticoduodenal groove in patients with BR/LAPC and set the stage for a follow-up clinical trial to place hydrogel as a spacer between the pancreatic tumor and dose-limiting, radiosensitive duodenum.
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UR - http://www.scopus.com/inward/citedby.url?scp=85084985444&partnerID=8YFLogxK
U2 - 10.1016/j.prro.2020.01.013
DO - 10.1016/j.prro.2020.01.013
M3 - Article
C2 - 32151732
AN - SCOPUS:85084985444
SN - 1879-8500
VL - 10
SP - e508-e513
JO - Practical Radiation Oncology
JF - Practical Radiation Oncology
IS - 6
ER -