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.
Verified March 2012 by Alberta Health Services
Sponsor:
Alberta Health Services
Information provided by (Responsible Party):
Alberta Health Services
ClinicalTrials.gov Identifier:
NCT00414570
First received: December 19, 2006
Last updated: March 19, 2012
Last verified: March 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Pancreatic Cancer |
Procedure: Positron-Emission Tomography (PET) 18F-FLT |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Alberta Health Services:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 30 |
| Study Start Date: | November 2006 |
| Estimated Study Completion Date: | November 2012 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00414570
Contacts
| Contact: Sandy McEwan, MD | 780-432-8524 | sandymce@cancerboard.ab.ca |
Locations
| Canada, Alberta | |
| Cross Cancer Institute | Recruiting |
| Edmonton, Alberta, Canada, T6G 1X2 | |
| Contact 780-432-8524 clinical_trials_cci@cancerboard.ab.ca | |
| Principal Investigator: Sandy McEwan, MD | |
Sponsors and Collaborators
Alberta Health Services
Investigators
| Principal Investigator: | Sandy McEwan, MD | Alberta Health Services |
More Information
No publications provided
| Responsible Party: | Alberta Health Services |
| ClinicalTrials.gov Identifier: | NCT00414570 History of Changes |
| Other Study ID Numbers: | SP-14-0054 / 23061 |
| Study First Received: | December 19, 2006 |
| Last Updated: | March 19, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Alberta Health Services:
|
Positron Emission Tomography (PET) 3'-deoxy-3'(18F)fluorothymidine ([18F]FLT) |
Additional relevant MeSH terms:
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine Alovudine Antimetabolites, Antineoplastic Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on May 19, 2013