In Vivo Assessment of Hypoxia in Gastro-intestinal Cancer Using 18F-HX4-PET: an Optimization and Reproducibility Study
Information source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pancreatic Cancer; Esophageal Cancer; Rectal Cancer
Intervention: [F-18]HX4 (Drug)
Phase: N/A
Status: Completed
Sponsored by: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Summary
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.
Clinical Details
Official title: In Vivo Assessment of Hypoxia in Gastro-intestinal Cancer Using 18F-HX4-PET: an Optimization and Reproducibility Study
Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Primary outcome: Reproducibility of SUV measured with 18F-HX4 PETOptimal time frame between administration of 18F-HX4 and PET scan
Detailed description:
Background of the 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.
Objective of the study:
In this study, we first intend to investigate the optimal time point for measurement of
hypoxia in esophageal, pancreatic and rectal cancer using 18F-HX4-PET and then assess
reproducibility of hypoxia measurements in these tumor types.
Study design:
In this study two steps will be taken. 1) First, as 18F-HX4-PET image quality may improve
when allowing for relatively longer time intervals after injection, in three patients with
esophageal, pancreatic or rectal cancer 18F-HX4-PET scans will be performed 90, 180 and 240
minutes after injection of 18F-HX4. The time-point with the best image quality (in terms of
tumor-to-background-ratio) will be chosen for the reproducibility study. 2) In the second
step, patients with proven esophageal, pancreatic or rectal cancer will undergo an
18F-HX4-PET twice within one week before start of treatment. 18F-HX4-PET will be performed
at 90, 180 or 240 minutes after injection of 18F-HX4, depending on the results of the first
part of the study. Reproducibility of hypoxia measured by 18F-HX4-PET will be assessed. In
those patients for whom tumor tissue is available which has not been treated with radiation
or chemotherapy, levels of hypoxia measured by 18F-HX4-PET will be compared with endogenous
hypoxia markers (HIF1-alfa, CA9, GLUT1, PAI-1, VEGF) using immunohistochemistry. In those
patients that underwent 18F-HX4-PET before start of neoadjuvant treatment, levels of hypoxia
measured by 18F-HX4-PET will be compared to pathological response after neoadjuvant
treatment.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Academic Medical Center, Amsterdam 1105AZ, Netherlands
Additional Information
Starting date: May 2012
Last updated: January 13, 2015
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