Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Retirement of former Qualified Investigator and lack of resources to complete study
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [18]F-FLT PET scan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [18]F-FLT PET scan
- description
- 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.
- interventionNames
- Drug: [18]F-FLT PET scan
Primary outcomes (2)
- measure
- 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
- timeFrame
- 5 Years
- measure
- correlate 18F-FLT uptake with hENT1 expression with biopsy samples where available
- timeFrame
- 5 Years
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available