Prostatic Neoplasms Clinical Trial
— HX4 SDOfficial title:
Non-invasive Imaging of Tumor Hypoxia With [18F]HX4 Positron-Emission-Tomography (PET): A Phase II Trial
NCT number | NCT02584400 |
Other study ID # | NL50833.068 |
Secondary ID | |
Status | Terminated |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | May 2016 |
Est. completion date | May 2017 |
Verified date | March 2019 |
Source | Maastricht Radiation Oncology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Regulation of tissue oxygen homeostasis is critical for cell function, proliferation and survival. Evidence for this continues to accumulate along with our understanding of the complex oxygen-sensing pathways present within cells. Several pathophysiological disorders are associated with a loss in oxygen homeostasis, including heart disease, stroke, and cancer. The microenvironment of tumors in particular is very oxygen heterogeneous, with hypoxic areas which may explain our difficulty treating cancer effectively. Prostate carcinomas are known to be hypoxic. Increasing levels of hypoxia within prostatic tissue is related to increasing clinical stage, patient age and a more aggressive prostate cancer. Several researches indicated that hypoxia might also play a role in esophageal cancer. In glial brain tumors, hypoxia is correlated with more rapid tumor recurrence and the hypoxic burden in newly diagnosed glioblastomas is linked to the biological aggressiveness. In brain metastases CA-IX expression (a marker for hypoxia) is correlated to the primary non-small cell lung carcinomas. Hypoxia enhances proliferation, angiogenesis, metastasis, chemoresistance and radioresistance of hepatocellular carcinoma. The hypoxic markers HIF-1α, VEGF, CA-IX and GLUT-1 were all over expressed in colorectal cancer and its liver metastases. Based on literature, hypoxia in tumors originating or disseminated to prostate, esophagus, brain and rectum cancer will be studied in this trial.
Status | Terminated |
Enrollment | 1 |
Est. completion date | May 2017 |
Est. primary completion date | May 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histological/cytological confirmed carcinoma of de esophagus, rectum or prostate or radiological suspicion for Grade IV glioma (primary brain tumor) or brain metastases - WHO performance status 0 to 2. - Adequate renal function (calculated creatinine clearance at least 60 ml/min). - The patient is willing and capable to comply with study procedures - 18 years or older - Have given written informed consent before patient registration Exclusion Criteria: - Recent (< 3 months) myocardial infarction - Pregnant or breast feeding and willing to take adequate contraceptive measures during the study |
Country | Name | City | State |
---|---|---|---|
Netherlands | MAASTRO Clinic | Maastricht | Limburg |
Lead Sponsor | Collaborator |
---|---|
Maastricht Radiation Oncology |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visualization of tumor hypoxia with [18F] HX4 PET imaging, valuated by the measurement of a tumor-to-background (T/B) ratio on the [18F]HX4 PET/CT | Visualization of tumor hypoxia with [18F] HX4 PET imaging | 4 years | |
Primary | Quantification of tumor hypoxia with [18F] HX4 PET imaging, evaluated by the measurement of a tumor-to-background (T/B) ratio on the [18F]HX4 PET/CT | Quantification of tumor hypoxia with [18F] HX4 PET imaging | 4 years | |
Secondary | Time between [18F] HX4 uptake with local and locoregional tumor recurrence and survival | Exploring the potential relationship of [18F] HX4 uptake with local and locoregional tumor recurrence and survival | 4 years | |
Secondary | Correlation of hypoxia imaging with blood hypoxia markers will be measured by the Pearson or Spearman correlation coefficient | Correlation of hypoxia imaging with blood hypoxia markers | 4 years | |
Secondary | Correlation of hypoxia imaging with tumor tissue biomarkers will be measured by the Pearson or Spearman correlation coefficient | Correlation of hypoxia imaging with tumor tissue biomarkers | 4 years | |
Secondary | Evaluation of tumor hypoxia changes during treatment by comparison of the PET uptake values in the tumor, measured before and during treatment | Evaluation of tumor hypoxia changes during treatment | 4 years | |
Secondary | Spatial correlation of [18F] HX4-PET with imaging pre-treatment using a correlation coefficient | Spatial correlation of [18F] HX4-PET with imaging pre-treatment (if present from routine clinical practice); performed by a rigid registration of the scans and a voxel wise comparison of the uptake within the tumor | 4 years | |
Secondary | Spatial correlation of [18F] HX4-PET with imaging three months after treatment using a correlation coefficient | Spatial correlation of [18F] HX4-PET with imaging three months after treatment (if present from routine clinical practice), performed by a rigid registration of the scans and a voxel wise comparison of the uptake within the tumor | 3 months |
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