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An Imaging Pilot Study of 18F-fluoro-3'-Deoxy-3'-L-fluorothymidine (18F-FLT) in Patients With Locally Advanced or Metastatic Pancreatic Cancer Who Will be Treated With Gemcitabine


N/A
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

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Trial Information

An Imaging Pilot Study of 18F-fluoro-3'-Deoxy-3'-L-fluorothymidine (18F-FLT) in Patients With Locally Advanced or Metastatic Pancreatic Cancer Who Will be Treated With Gemcitabine


Inclusion Criteria:



- male or female ≥ 18 years of age. If female of child bearing potential and outside
of the window of 10 days since the first day of the last menstrual period, a negative
pregnancy test

- patients with known locally advanced or metastatic carcinoma of the pancreas

- planned gemcitabine treatment

- calculated creatinine clearance >50ml/min (calculated by Crockcraft and Gault
equation)

- able and willing to follow instructions and comply with the protocol

- provide written consent prior to participation in this study

- Karnofsky Performance Scale Score 60-100

Exclusion Criteria:

- Bilirubin ≥200 umol/L

- AST or ALT ≥5 times the upper limits of normal

- Serious medical conditions which may prevent a patient from tolerating experimental
chemotherapy such as: congestive heart failure, unstable angina, unstable ventricular
arrhythmia, uncontrolled psychiatric conditions, serious infections, uncontrolled
diabetes

- uncontrolled brain metastasis. Patients who have stable brain metastasis treated
with radiation or surgery who are symptomatic and a stable dose of dexamethasone are
eligible

- nursing females

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

compare response to chemotherapy, time to disease progression and overall survival in pancreatic cancer patients treated with gemcitabine who demonstrate 18F-FLT uptake to those patients who do not demonstrate 18F-FLT uptake

Outcome Time Frame:

5 Years

Principal Investigator

Sandy McEwan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Alberta Health Services

Authority:

Canada: Health Canada

Study ID:

SP-14-0054 / 23061

NCT ID:

NCT00414570

Start Date:

November 2006

Completion Date:

November 2012

Related Keywords:

  • Pancreatic Cancer
  • Positron Emission Tomography (PET)
  • 3'-deoxy-3'(18F)fluorothymidine ([18F]FLT)
  • Pancreatic Neoplasms

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