Spectroscopy From Duodenum



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:January 2013
Contact:Michael B Wallace, M.D.
Email:Wallace.Michael@mayo.edu
Phone:(904)953-7382

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Duodenal Spectroscopy Study for Cancer Diagnosis

Purpose of this study is to understand the clinical feasibility of duodenal spectroscopy to
adenocarcinoma patients.

Pancreatic cancer (PC) is the most lethal of all major cancers with a five year survival
rate of 5 %. While stage I and II tumors leads to an improvement in survival, almost all PCs
are currently diagnosed at more advanced non-resectable stages since minimally invasive
technique which is capable of screening early-stage PC does not exist. Serum CA19-9 is not
recommended as a screening technique because of its low sensitivity and specificity. Imaging
modalities such as MRI, CT, EUS and ERCP are more accurate but are not appropriate screening
tools due to their high cost, discomfort and complications. Therefore, there is a strong
demand for a screening tool with high sensitivity and specificity which is highly acceptable
for the patient. The investigators would like to look at the spectroscopy technique for
pancreatic cancer diagnosis via an upper endoscopy. A definite diagnosis of the patient is
made with histology, cytology or imaging diagnosis. Therefore this study can be positioned
as a feasibility study.

Inclusion Criteria:

- Common inclusion criterion

- Age is 18 years or older.

- Informed consent was obtained.

- Inclusion criterion for normal cohort

- An upper GI endoscopy is scheduled to check upper abdominal symptoms.

- No findings of pancreatic disorder as documented by CT or MRI or EUS

- Inclusion criterion for PC suspicious cohort * A EUS or ERCP is scheduled to
suspected pancreatic disorder.

Exclusion Criteria:

- Common exclusion criterion

- Severe cardiac disease

- Severe respiratory disease

- Bleeding disorders

- Pregnancy
We found this trial at
3
sites
4500 San Pablo Rd S
Jacksonville, Florida 32224
(904) 953-2000
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