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

NCT00414570 | Terminated Early Phase 1

• 1 other identifier: DX-FLT-001
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives 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 (or other nucleoside analogs) who demonstrate \[18\]F-FLT uptake to those patients who do not demonstrate \[18\]F-FLT uptake; (ii) to correlate \[18\]F-FLT uptake with hENT1 expression in biopsy samples where available; (iii)to determine the presence or absence of uptake, the relative uptake score (RUS), standardized uptake value (SUV), and tumor to background ratios (T/B) of \[18\]F-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 \[18\]F-FLT.

Conditions

Pancreatic Cancer

Keywords

Positron Emission Tomography (PET); 3'-deoxy-3'(18F)fluorothymidine ([18]F-FLT)

Outcome Measures

Primary Outcomes (2)

• 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

  5 Years

• correlate 18F-FLT uptake with hENT1 expression with biopsy samples where available

  5 Years

Secondary Outcomes (2)

• 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

  5 Years

• to demonstrate the safety of 18F-FLT manufactured at the Edmonton PET Centre

  5 Years

Study Arms (1)

[18]F-FLT PET scan

EXPERIMENTAL

Radioactive dose of 2.59 MBq/kg (range 100 - 350 MBq) \[18\]F-FLT per injection prior to Positron Emission Tomography (PET) imaging. \[18\]F-FLT PET scans at baseline/pre-treatment and at disease progression, up to a maximum of two separate \[18\]F-FLT PET scans per participant.

Drug: [18]F-FLT PET scan

Interventions

[18]F-FLT PET scan DRUG

Injection of \[18\]F-FLT radiopharmaceutical followed by PET imaging.

Also known as: [18]F-FLT Positron Emission Tomography scan

[18]F-FLT PET scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead
• Cross Cancer Institute: collaborator

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Michael B Sawyer, MD

  Cross Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2006
• First Posted: December 21, 2006
• Study Start: November 1, 2007
• Primary Completion: February 6, 2019
• Study Completion: February 6, 2019
• Last Updated: August 28, 2019

Record last verified: 2019-02

Locations

CA (1)