Not provided
Not provided
Not provided
Not provided
patients did not want to participate
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [18F] HX4 PET imaging | Experimental | injection with [18F] HX4 and PET imaging at baseline and after 20 Gy radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| injection with [18F] HX4 and PET imaging | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Visualisation of tumor hypoxia with [18F] HX4 PET imaging | Visualisation of tumor hypoxia with [18F] HX4 PET imaging | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Observation of spatial and temporal stability of [18F] HX4 PET images | Observation of spatial and temporal stability of [18F] HX4 PET images | 2 year |
| Correlations with Complete Remission rates at 3 months restaging evaluation |
Not provided
Inclusion criteria
Exclusion criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Philippe Lambin, prof MD PhD | Maastro Clinic, The Netherlands | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MAASTRO clinic | Maastricht | 6229 ET | Netherlands |
Not provided
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| D007267 | Injections |
| D009682 | Magnetic Resonance Spectroscopy |
| C553729 | 3-fluoro-2-(4-((2-nitro-1H-imidazol-1-yl)methyl)-1H-1,2,3-triazol-1-yl)propan-1-ol |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D013057 | Spectrum Analysis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
Correlations with Complete Remission rates at 3 months restaging evaluation
| 2 year |
| Image quality of [18F] HX4-PET at different time points | Image quality of [18F] HX4-PET at different time points | 2 year |
| Kinetic analysis of HX4 | Kinetic analysis of HX4 | 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) | 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 | 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 | 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 | 2 year |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002623 |
| Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |