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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00885248
Other study ID # 2008-0623
Secondary ID
Status Active, not recruiting
Phase N/A
First received April 20, 2009
Last updated April 20, 2009
Start date January 2009
Est. completion date December 2009

Study information

Verified date April 2009
Source Asan Medical Center
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Observational

Clinical Trial Summary

In suspecting pancreatic cancer, dynamic phase pancreatic CT is the most effective tool in diagnosis and staging. In addition, magnetic resolution image, endoscopic ultrasonography, endoscopic retrograde pancreatography, angiography can be performed.

After introduction of functional image, PET has been suggested in the role of diagnosis and staging of pancreatic cancer. Furthermore, recently fused images of PET and CT were available.

In this study, the researchers evaluate the role of integrated PET-CT in patients with pancreatic cancer and analysis the cost-effectiveness of the integrated PET-CT.


Description:

Compared to dynamic phase pancreatic CT, integrated PET-CT will be evaluated for sensitivity, specificity and accuracy of diagnosing and staging pancreatic cancer while the gold standard for pancratic cancer is operative specimen. If the operation can't be performed, EUS-FNA of the pancreatic mass or lymph node and additional imaging modality will be preferred to laparotomy.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 70
Est. completion date December 2009
Est. primary completion date November 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Pancreatic mass suspicious of pancreatic cancer

- No comorbidity, expected life expectancy less than 6 months

- Consent this study in letter

Exclusion Criteria:

- Refuse diagnostic and staging work-up

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Korea, Republic of Asan Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Staging of pancreatic cancer 6 months after study start No
Secondary Diagnosis of pancreatic cancer 6 months after study start No
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