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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

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ClinicalTrials.gov Identifier: NCT00414570
Recruitment Status : Terminated (Retirement of former Qualified Investigator and lack of resources to complete study)
First Posted : December 21, 2006
Last Update Posted : August 28, 2019
Sponsor:
Collaborator:
Cross Cancer Institute
Information provided by (Responsible Party):
AHS Cancer Control Alberta

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: [18]F-FLT PET scan Early Phase 1

Detailed Description:
The proposed clinical trial will be an imaging, open label, non-randomized, single site pilot study in patients with locally advanced or metastatic pancreatic carcinoma who will be treated with gemcitabine or other nucleoside analogs. Study participants will receive an IV injection of 2.59 MBq/kg ± 10% of [18]F-FLT (range: 100 to 350 MBq). If clinically indicated, dynamic PET scan imaging may start immediately before the injection, followed by half-body or limited frame scanning, using either a PET/CT or PET scanner. The first [18]F-FLT PET scan for each subject will occur within 4 weeks prior to commencement of his/her treatment. Study subjects will have a follow-up [18]F-FLT-PET scan at the time of disease progression, to a maximum of two [18]F-FLT PET scans. The same imaging procedure will be followed for both [18]F-FLT PET scans. At the same time as the [18]F-FLT PET scans occur, the patients' index tumour lesions will be re-evaluated by the same imaging modality originally used to assess the index lesions. Images will be interpreted by an experienced Nuclear Medicine physician with regard to normal physiological uptake of [18]F-FLT (RUS, SUV, and T/B). The location and relative uptake of normal and abnormal [18]F-FLT biodistribution patterns will be noted and correlated with time to disease progression and hENT1 expression in biopsy samples, where available. A medical chart review will be done at regular intervals to assess response to treatment, time to disease progression, and overall survival. Disease progression will be determined using the National Cancer Institute's Response Evaluation Criteria In Solid Tumours (RECIST).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Actual Study Start Date : November 2007
Actual Primary Completion Date : February 6, 2019
Actual Study Completion Date : February 6, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: [18]F-FLT PET scan
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
Injection of [18]F-FLT radiopharmaceutical followed by PET imaging.
Other Name: [18]F-FLT Positron Emission Tomography scan




Primary Outcome Measures :
  1. 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 ]
  2. correlate 18F-FLT uptake with hENT1 expression with biopsy samples where available [ Time Frame: 5 Years ]

Secondary Outcome Measures :
  1. 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 ]
  2. to demonstrate the safety of 18F-FLT manufactured at the Edmonton PET Centre [ Time Frame: 5 Years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00414570


Locations
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Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
AHS Cancer Control Alberta
Cross Cancer Institute
Investigators
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Principal Investigator: Michael B Sawyer, MD Cross Cancer Institute

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Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT00414570    
Other Study ID Numbers: DX-FLT-001
First Posted: December 21, 2006    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: February 2019
Keywords provided by AHS Cancer Control Alberta:
Positron Emission Tomography (PET)
3'-deoxy-3'(18F)fluorothymidine ([18]F-FLT)
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases