"EARLY FEASIBILITY STUDY FOR EVALUATION OF THE TRACEIT® TISSUE SPACER FOR CREATING SPACE BETWEEN THE DUODENUM AND PANCREAS IN PATIENTS WITH BORDERLINE RESECTABLE OR LOCALLY ADVANCED PANCREATIC CANCER UNDERGOING A COURSE OF SBRT (THE TIPS PILOT STUDY)"
Johns Hopkins Kimmel Cancer Center in Baltimore
To evaluate the feasibility, radiotherapy benefits, and safety when using TraceIT Tissue Spacer to create space between the pancreas and duodenum.
Inclusion Criteria:1.Age equal to 18 years old2.Biopsy-confirmed BRPC and LAPC in the head or neck of the pancreas that is able to be visualized via CT or other imaging modality (e.g., PET) with no evidence of distant metastasis (AJCC clinical stage IIA-III) as defined by the NCCN guidelines: 3.Tumor is clearly delineable from duodenum with at least 1mm of space visible and no invasion of the duodenum is seen at time of EUS performed for either diagnosis or fiducial placement.4.Subject is able to comply with motion management guidelines5.Radiotherapy or chemoradiotherapy for treatment of the disease is indicated with the intent for eventual surgical resection6.In Investigator’s opinion, medically fit to undergo endoscopy for fiducial marker implantation and TraceIT administration7.Subjects Screening/Baseline laboratory testing must meet the following laboratory value criteria:a.White blood cell count: equal to 3.0 x 109/Lb.Absolute neutrophil count (ANC): equal to 1.5 x 109/L c.Platelets: equal to 100 x 109/Ld.Total bilirubin: equal to 2.0 times upper limit of normal (ULN)e.AST and ALT: equal to 3.0 times institutional upper normal limitf.Serum creatinine: less than 1.5 times ULN g.INR: less than 1.5h.Serum pregnancy: Negativei.Hemoglobin: equal to 8.0 g/dl8.Zubrod Performance Status 0-29.Subject or authorized representative, has been informed of the nature of the study and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) of the respective clinical site10.Life expectancy of at least 9 monthsExclusion:1.Patients for whom radiotherapy is contraindicated2.Previous thoracic or abdominal radiotherapy3.Any GI abnormality that would interfere with the ability to access the injection site 4.Presence of tumor invasion detected on EUS at time of biopsy 5.Previous Whipple procedure or other resection of pancreatic tumor prior to screening6.Active gastroduodenal ulcer or watery diarrhea7.History of Chronic Renal Failure8.Documented history of uncontrolled diabetes (i.e., symptomatic hyperglycemia that cannot be medically managed, fasting blood glucose level above 300 mg/dL, and/or frequent swings between hyperglycemia and hypoglycemia)9.Currently enrolled in another investigational drug or device trial that clinically interferes with this study10.Unable to comply with the study requirements or follow-up schedule11.Any condition or comorbidity that the Investigator believes would interfere with the intent of the study or would make participation not in the best interest of the subject12.Pregnancy, breast-feeding, women of child-bearing age must use contraceptives.
Multicenter prospective, single-arm early feasibility study. Six (6) subjects with either borderline resectable or locally advanced pancreatic cancer (defined per NCCN guidelines) having completed induction chemotherapy and for whom a course of SBRT is indicated will be enrolled. Enrolled subjects will undergo placement of intrapancreatic fiducial markers and peri-duodenal administration of TraceIT hydrogel within the same endoscopic ultrasound transduodenal procedure. The hydrogel will be distributed in small volumes (generally ~1 to 2 mL and up to a total of 20 mL) at several areas along the proximal portion of the duodenum in the areas closest to the head of the pancreas (HOP). SBRT simulation planning will be performed prior to and following TraceIT placement for evaluation and comparison of duodenal dose / dose distribution and to assess differences in SBRT dosing parameters. The pre- and post-TraceIT injection simulation planning will be performed using the identical technique and similar set-up, and with appropriate respiratory motion control (e.g., feedback-guided inspiratory breath-hold gating, end expiratory gating during free breathing or abdominal compression as appropriate). In accordance with standard medical practice, within 2-6 weeks after completion of therapy, subjects will be restaged to determine whether they may progress to surgery. If surgical resection is attempted and successful, pathological data will be recorded within the study eCRF.All subjects will be evaluated at minimum 3 and 6 months post-TraceIT administration. An MR will be performed at the 6 month visit to evaluate for TraceIT presence. Throughout the duration of the study, subjects will be clinically evaluated and assessed for duodenal adverse events using the grading of the NCI Common Terminology Criteria for Adverse Events (CTCAEv4). Quality of life data will be collected using the EORTC QLQ-PAN26 and QLQ-C30 questionnaires.Additional longer-term follow-up clinic visits will be performed in accordance with standard of care, at minimum, 12 and 18 months.
03/05/2019 05:03 AM