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Trial record 51 of 2070 for:    Pancreatic Cancer AND Digestive System Neoplasms

In Vivo Assessment of Hypoxia in Gastro-intestinal Cancer Using 18F-HX4-PET: an Optimization and Reproducibility Study (HYPE)

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ClinicalTrials.gov Identifier: NCT01995084
Recruitment Status : Completed
First Posted : November 26, 2013
Last Update Posted : January 14, 2015
Sponsor:
Information provided by (Responsible Party):
H.W.M. van Laarhoven, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief 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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Esophageal Cancer Rectal Cancer Drug: [F-18]HX4 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: In Vivo Assessment of Hypoxia in Gastro-intestinal Cancer Using 18F-HX4-PET: an Optimization and Reproducibility Study
Study Start Date : May 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Optimization
Patients undergo a [F-18]HX4 PET/CT scan 2,3 and 4h after [F-18]HX4 injection.
Drug: [F-18]HX4
400 MBq [F-18]HX4, is administered in a single intravenous bolus injection, followed by a saline flush.
Other Names:
  • [18 F]-3-Fluoro-2-(4-((2-nitro-1H-imidazol-1-yl)methyl)-
  • 1H-1,2,3-triazol-1-yl)propan-1-ol

Experimental: Reproducibility
Patients undergo two [F-18]HX4 PET/CT scans 3.5h after [F-18]HX4 injection within a 10-day time frame.
Drug: [F-18]HX4
400 MBq [F-18]HX4, is administered in a single intravenous bolus injection, followed by a saline flush.
Other Names:
  • [18 F]-3-Fluoro-2-(4-((2-nitro-1H-imidazol-1-yl)methyl)-
  • 1H-1,2,3-triazol-1-yl)propan-1-ol




Primary Outcome Measures :
  1. Reproducibility of SUV measured with 18F-HX4 PET [ Time Frame: Within 10 days ]
    Tumor SUVmean, SUVmax, Uptake Ratio

  2. Optimal time frame between administration of 18F-HX4 and PET scan [ Time Frame: 2-4h after injection ]
    Tumor SUVmean, SUVmax, Uptake Ratio



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01995084


Locations
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Netherlands
Academic Medical Center
Amsterdam, Netherlands, 1105AZ
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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Responsible Party: H.W.M. van Laarhoven, M.D., Ph.D., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT01995084     History of Changes
Other Study ID Numbers: NL40274.018.12
First Posted: November 26, 2013    Key Record Dates
Last Update Posted: January 14, 2015
Last Verified: January 2015
Keywords provided by H.W.M. van Laarhoven, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
hypoxia
HX4
PET
cancer
Additional relevant MeSH terms:
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Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Hypoxia
Gastrointestinal Diseases
Intestinal Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Imidazole
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action