Radiopaque Hydrogel in Patients Undergoing Radiotherapy for Pancreatic Cancer

Inclusion Criteria:

1. Age ≥18 years old
2. BR/LAPC pancreatic carcinoma disease
3. Radiotherapy or chemoradiotherapy for treatment of the disease is indicated with the intent for eventual surgical resection
4. Subjects Screening/Baseline laboratory testing must meet the following laboratory value criteria:

   1. White blood cell count: ≥ 3.0 x 109/L
   2. Absolute neutrophil count (ANC): ≥ 1.5 x 109/L
   3. Platelets: ≥ 100 x 109/L
   4. Total bilirubin: ≤ 2.0 times upper limit of normal (ULN)
   5. AST (Aspartate Aminotransferase) and ALT (Alanine Aminotransferase): ≤ 3.0 times institutional upper normal limit
   6. Serum creatinine: 1.5 times ULN (upper limit of normal)
   7. INR (international normalized ratio): \< 1.5
   8. Serum pregnancy: Negative
   9. Hemoglobin: ≥ 8.0 g/dl
5. Zubrod Performance Status 0-2
6. 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 site.

Exclusion Criteria:

1. Previous thoracic radiotherapy
2. Any GI (gastrointestinal) abnormality that would interfere with the ability to access the injection site
3. Active gastroduodenal ulcer or watery diarrhea
4. Active bleeding disorder or a clinically significant coagulopathy defined as a PTT (Partial thromboplastin time) \>35s or INR\>1.4 or platelet count less than 100,000 per mm3.
5. Active inflammatory or infectious process involving the gastrointestinal tract based on positive diagnosis or suspected diagnosis in the presence of fever\>38°C or WBC\>12,000/uL.
6. Compromised immune system: WBC (white blood count) \<4000/uL or \>12,000/uL.
7. History of Chronic Renal Failure.
8. 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 study.
10. Unable to comply with the study requirements or follow-up schedule.
11. 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 subject.
12. Pregnancy, breast-feeding, women of child-bearing age must use contraceptives