A Phase 2 interventional study of injection with [18F] HX4 and PET imaging in Cervix Cancer, sponsored by Maastricht Radiation Oncology. Terminated at 1 site in Netherlands. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-08.
Sponsored by Maastricht Radiation Oncology · Phase 2, Interventional, and Diagnostic
The aim of this study is:
Tumor hypoxia is the situation where tumor cells are or have been deprived of oxygen. Hypoxic tumor cells are usually more resistant to radiotherapy and chemotherapy and more likely to develop metastasis. In Cervix cancer, tumor hypoxia is known to be an important prognostic factor for long term survival. [18F]HX4 is being developed as a diagnostic radiopharmaceutical for PET imaging to find a marker for hypoxia that can be used in standard clinical practice. Current hypoxia tracers lack reliable image quality and kinetics. Because of the short half life and clearance, the investigators expect that [18F]HX4 will have a higher tumor to background ratio than current nitro-imidazole hypoxia markers such as [18F]-misonidazole. In a recent phase 1 clinical study from van Loon et al, PET-imaging with [18F]HX4 was feasible without any toxicity. The clinical use of a reliable, non-invasive and easy to use hypoxia imaging agent could allow selection of patients most likely to benefit from hypoxia modifying therapies.
1,879 studies on the registry are indexed under Uterine Cervical Neoplasms; 565 are open to participants now.
This study's enrollment of 4 is below the median of 100 across 1,375 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Maastricht Radiation Oncology is the lead sponsor of 104 studies on the registry; 9 are open to participants now.
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Exclusion criteria
injection with \[18F\] HX4 and PET imaging at baseline and after 20 Gy radiotherapy
Other: injection with [18F] HX4 and PET imaging
A standard clinical \[18F\]FDG PET-CT will be performed for the radiotherapy planning. After a minimum time interval of 24 hours, baseline \[18F\]HX4 PET scans will be performed: Based on the phase I trial1 444 MBq (12 mCi) \[18F\]HX4 is administrated via a bolus IV injection. The first image acquisition is started together with the administration of \[18F\]HX4 (30-40 min dynamic). Static scans are acquired at 90 min, 180 min and 240 min p.i
Also known as: 3-[18F]fluoro- 2-(4-((2-nitro-1H-imidazol-1-yl)methyl)-1H-1,2,3-triazol-1- yl)propan-1-ol
Visualisation of tumor hypoxia with [18F] HX4 PET imaging
Visualisation of tumor hypoxia with \[18F\] HX4 PET imaging
Time frame: 2 year
Observation of spatial and temporal stability of [18F] HX4 PET images
Observation of spatial and temporal stability of \[18F\] HX4 PET images
Time frame: 2 year
Correlations with Complete Remission rates at 3 months restaging evaluation
Correlations with Complete Remission rates at 3 months restaging evaluation
Time frame: 2 year
Image quality of [18F] HX4-PET at different time points
Image quality of \[18F\] HX4-PET at different time points
Time frame: 2 year
Kinetic analysis of HX4
Kinetic analysis of HX4
Time frame: 2 year
Correlation of hypoxia imaging with blood hypoxia markers (osteopontin, circulating CA-IX)
Correlation of hypoxia imaging with blood hypoxia markers (osteopontin, circulating CA-IX)
Time frame: 2 year
Correlation of hypoxia imaging with tumor tissue biomarkers (HPV, CA-IX, VEGF, EGFR, CD44, HIF-1α, mir-210) and autophagy related genes
Correlation of hypoxia imaging with tumor tissue biomarkers (HPV, CA-IX, VEGF, EGFR, CD44, HIF-1α, mir-210) and autophagy related genes
Time frame: 2 year
Spatial correlation of [18F] HX4-PET with [18F] FDG PET pre-treatment
Spatial correlation of \[18F\] HX4-PET with \[18F\] FDG PET pre-treatment
Time frame: 2 year
Spatial correlation of [18F] HX4-PET with [18F] FDG PET three months after treatment
Spatial correlation of \[18F\] HX4-PET with \[18F\] FDG PET three months after treatment
Time frame: 2 year
This study is terminated, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Maastricht Radiation Oncology