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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by AHS Cancer Control Alberta
Sponsor:
Information provided by (Responsible Party):
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT00414570
First received: December 19, 2006
Last updated: February 4, 2014
Last verified: February 2014

December 19, 2006
February 4, 2014
November 2006
October 2014   (final data collection date for primary 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 [ Time Frame: 5 Years ]
  • correlate 18F-FLT uptake with hENT1 expression with biopsy samples where available [ Time Frame: 5 Years ]
  • 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
  • correlate 18F-FLT uptake with hENT1 expression with biopsy samples where available
Complete list of historical versions of study NCT00414570 on ClinicalTrials.gov Archive Site
  • determine the presence or absence of uptake, the relative uptake score (RUS) and tumor background ratios of 18F-FLT in patients with known carcinoma of the pancreas and assess this uptake in relation to time of disease progression [ Time Frame: 5 Years ]
  • to demonstrate the safety of 18F-FLT manufactured at the Edmonton PET Centre [ Time Frame: 5 Years ]
  • determine the presence or absence of uptake, the relative uptake score (RUS) and tumor background ratios of 18F-FLT in patients with known carcinoma of the pancreas and assess this uptake in relation to time of disease progression
  • to demonstrate the safety of 18F-FLT manufactured at the Edmonton PET Centre
Not Provided
Not Provided
 
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
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

The objective of this pilot study are (i) to compare response to chemotherapy, time to disease progression and overall survival in patients with pancreatic cancer who will be treated with gemcitabine who demonstrate 18F-FLT uptake to those patients who do not demonstrate 18F-FLT uptake; (ii) to correlate 18F-FLT uptake with hENT1 expression with biopsy samples where available; (iii)to determine the presence or absence of uptake, the relative uptake score (RUS) and tumor to background ratios of 18F-FLT in patients with known carcinoma of the pancreas and assess this uptake in relation to time to disease progression; and (iv) to demonstrate the safety of 18F-FLT manufactured at the Edmonton PET Centre.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Pancreatic Cancer
Procedure: Positron-Emission Tomography (PET) 18F-FLT
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
October 2014
October 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Sandy McEwan, MD 780-432-8524 sandymce@cancerboard.ab.ca
Canada
 
NCT00414570
SP-14-0054 / 23061
Yes
AHS Cancer Control Alberta
AHS Cancer Control Alberta
Not Provided
Principal Investigator: Sandy McEwan, MD AHS Cancer Control Alberta
AHS Cancer Control Alberta
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP