Pancreatic Cancer | In Vivo Assessment of Hypoxia in Gastro-intestinal Cancer Using 18F-HX4-PET: an Optimization and Reproducibility Study
Pancreatic Cancer research study
What is the primary objective of this study?
Several studies have shown that tumour hypoxia may have a negative impact on the outcome of anticancer treatment. Assessment of tumor hypoxia at baseline or shortly after start of treatment may serve as a predictive marker to determine treatment efficacy at an early stage. Preferably, such an assessment is performed in vivo and non-invasively.Non-invasive imaging with positron emission tomography (PET) using the 2-nitroimidazole nucleoside analogue, 3-18F-fluoro-2-(4-((2-nitro-1H-imidazol-1-yl)methyl)-1H-1,2,3-triazol-1- yl)propan-1-ol (18F-HX4), was tested as a new marker of tumor hypoxia. Before hypoxia-measurements can be clinically implemented for response prediction, the reproducibility of the technique should be assessed for each specific tumor type. Knowledge of reproducibility is needed to determine what change in parameters between two examinations can be considered relevant in an individual patient. Assessment of reproducibility becomes even more important in early response monitoring since the changes in the tumor induced by the treatment may be smaller during the treatment compared to response monitoring after completion of treatment. Also, as image quality of 18F-HX4-PET increases with increasing time intervals after injection, determination of the optimal time point for measurement of hypoxia is warranted.
Who is eligible to participate?
Inclusion Criteria: - Patients with biopsy proven invasive carcinoma of the esophagus, pancreas or rectum. In pancreatic cancer cytological proof or a high suspicion on CT imaging is allowed, too. - Tumor size ≥ 1cm - WHO-performance score 0-2 - Written informed consent Exclusion Criteria: - Any psychological, familial, sociological or geographical condition potentially hampering adequate informed consent or compliance with the study protocol. - Surgery, radiation and/or chemotherapy foreseen within the timeframe needed for two PET scans.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:[F-18]HX4400 MBq [F-18]HX4, is administered in a single intravenous bolus injection, followed by a saline flush.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
OptimizationPatients undergo a [F-18]HX4 PET/CT scan 2,3 and 4h after [F-18]HX4 injection.
ReproducibilityPatients undergo two [F-18]HX4 PET/CT scans 3.5h after [F-18]HX4 injection within a 10-day time frame.
Start Date: May 2012
Completed Date: June 2014
Primary Outcome: Reproducibility of SUV measured with 18F-HX4 PET
Study sponsors, principal investigator, and references
Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)