Non-invasive Imaging With [18F]VM4-037

Maastricht Radiation Oncology

Status and phase: Withdrawn; Phase 1

Conditions: Stage 4 Cancer

Treatments: Drug: [18F]VM4-037

Study type: Interventional

Funder types: Other

Identifiers

NCT00935142

[18F]VM4-037

CaIX

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)