Clinical trial · Interventional
Non-invasive Imaging With [18F]VM4-037
Non Invasive Imaging of [18F]VM4-037 With Positron-Emission-Tomography (PET): A Phase I Trial
NCT00935142CI-TRIAL-00009134[18F]VM4-037withdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to determine the toxicity of the hypoxia PET-tracer \[18F\]-VM4-037 in cancer patients in two dose-steps: * Step 1 (3-6 patients): a single dose of maximum 8 mCi (296 MBq) dose of \[18F\]VM4-037 via a bolus IV injection. * Step 2 (3-6 patients): a single dose of maximum 12 mCi (444 MBq) dose of \[18F\]VM4-037 via a bolus IV injection
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 |
|---|---|---|---|
| Stage 4 Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [18F]VM4-037 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Toxicity (CTCAE 3.0)
- timeFrame
- 1 week
Secondary outcomes (3)
- measure
- Image Quality
- timeFrame
- 1 week
- measure
- Correlation with circulating biomarkers of hypoxia
- timeFrame
- 1 week
- measure
- Correlation with [18F]-FDG on PET scans
- timeFrame
- 1 week
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 * WHO performance status 0 to 1 * Normal white blood cell count and formula * 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 * The patient is capable of complying with study procedures * 18 years or older Exclusion Criteria: * Only visible tumor sites in the upper abdomen (because the uptake of VM4-037 in the liver, stomach and the kidneys would interfere with image quality of the tumor) * Known hypersensitivity for sulfonamides * Recent (\< 3 months) myocardial infarction * Uncontrolled infectious disease * Less than 18 years old * Pregnancy * No concurrent anti-cancer agents or radiotherapy allowed
References
Publications (0)
Data not yet available
No reference posted for this study.