An Early Phase 1 interventional study of [18]F-FLT PET scan in Pancreatic Cancer, sponsored by AHS Cancer Control Alberta. Terminated at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-28.
Sponsored by AHS Cancer Control Alberta · Early Phase 1, Interventional, and Diagnostic
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.
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).
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's enrollment of 11 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →AHS Cancer Control Alberta is the lead sponsor of 182 studies on the registry; 31 are open to participants now.
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Exclusion Criteria:
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.
Also known as: [18]F-FLT Positron Emission Tomography scan
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
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
This study is terminated, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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AHS Cancer Control Alberta