Clinical trial · Interventional
Non-Invasive Imaging of [18F]HX4 With Positron-Emission-Tomography (PET)
Non-Invasive Imaging of [18F]HX4 With Positron-Emission-Tomography (PAT): A Phase I Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Non invasive imaging of hypoxia with the aid of PET-scans could help to select the patients having a hypoxic tumour who could be treated with specific anti-hypoxic treatments such as bio-reductive drugs or hypoxic radio-sensitizers. Several 2-nitroimidazoles to which the compound to be tested, HX-4, belongs, labelled with Fluor-18 have already been used in patients. However, bad image quality and unpredictable kinetics limit their use. In extensive pre-clinical models, the combination of HX-4 labelled with Fluor-18 is a promising non-toxic new probe to determine hypoxia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Injection of HX-4 | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Procedure: Injection of HX-4
Primary outcomes (1)
- measure
- Toxicity (CTCAE 3.0)
- timeFrame
- 9 months
Secondary outcomes (1)
- measure
- Image Quality at different time points (Tumour-to-Background Ratio determined by PET-CT scan)
- timeFrame
- 9 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological or cytological confirmed solid tumour, primary or secondary stage IV and/ or tumours with no curative treatment options. * Normal white blood cell count and neutrophils * Normal platelet count * No anaemia requiring blood transfusion or erythropoietin * Adequate hepatic function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for the institution; ALT, AST, and alkaline phosphatase ≤ 2.5 x ULN for the institution). * Calculated Creatinin clearance at least 60 ml/min * No administration of Fluor-18 in the previous 24 hours * Capable of complying with study procedures
References
Publications (0)
Data not yet available