Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00414570
Status:
TERMINATED
Last Update Posted:
2019-08-28
First Post:
2006-12-19
Brief Title:
An Imaging 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 or Other Nucleoside Analogs
Sponsor:
AHS Cancer Control Alberta
Organization:
AHS Cancer Control Alberta
Study Overview
Official Title:
None
Status:
TERMINATED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Retirement of former Qualified Investigator and lack of resources to complete study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 18F-FLT uptake to those patients who do not demonstrate 18F-FLT uptake ii to correlate 18F-FLT uptake with hENT1 expression in biopsy samples where available iiito determine the presence or absence of uptake the relative uptake score RUS standardized uptake value SUV and tumor to background ratios TB 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
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 259 MBqkg 10 of 18F-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 PETCT or PET scanner The first 18F-FLT PET scan for each subject will occur within 4 weeks prior to commencement of hisher treatment Study subjects will have a follow-up 18F-FLT-PET scan at the time of disease progression to a maximum of two 18F-FLT PET scans The same imaging procedure will be followed for both 18F-FLT PET scans At the same time as the 18F-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 18F-FLT RUS SUV and TB The location and relative uptake of normal and abnormal 18F-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 Institutes Response Evaluation Criteria In Solid Tumours RECIST
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None