EUS-guided PDT in Pancreatic Tumors

Inclusion Criteria:

1. Histological/cytological diagnosis of locally advanced or small volume metastatic
pancreatic cancer or other solid pancreatic tumor that is not amendable to curative
surgical resection or the patient is unfit for surgery

2. Measureable disease as defined by the Response Evaluation Criteria in Solid Tumors
(RECIST)

3. ECOG performance status 0,1 or 2

4. Estimated life expectancy of at least 12 weeks

5. Capable of giving informed consent

6. adequate biliary drainage (serum bilirubin < 2.5 ULN) with no evidence of active
uncontrolled infection (patients on antibiotics are eligible)

7. Women of childbearing potential with a negative pregnancy test (qualitative serum HCG)
prior to study entry and must be using adequate contraception method and continue this
for one week after PDT

8. Must be willing and able to travel to study site for screening, treatment and all
follow up visits

Exclusion Criteria:

1. Evidence of metastases other than lung or liver and if lung or liver metastases are
present, greater than three lesions, and any lesion greater than 5cm. in diameter

2. Porphyria; Pregnant or breast-feeding

3. Locally advanced disease involving >50% circumference of the duodenum or a major
artery (hepatic, gastro-duodenal) with in the treatment area

4. ECOG performance status of 3 or 4

5. Previous treatment with curative intent for current disease in the last 12 weeks (i.e.
prior resection, radical radiotherapy or chemotherapy)

6. Any psychiatric disease making reliable informed consent impossible

7. A history of documented hemorrhagic diathesis or coagulopathy, currently on
therapeutic anticoagulation. History of prior or concomitant other malignancy that
will interfere with the response evaluation

8. Any evidence of severe of uncontrolled systemic disease or laboratory finding that in
the view of the investigator makes it unsafe for the patient to participate in the
study

9. Contrast allergy not amendable to treatment with steroids and antihistamines