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

NCT ID: NCT00935142

Last Updated: 2013-01-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-11-30

Brief Summary

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

Stage 4 Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

[18F]VM4-037

Bolus IV injection of \[18F\]VM4-037

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: collaborator

Maastricht Radiation Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe Lambin, MD. PhD.

Role: PRINCIPAL_INVESTIGATOR

Maastro Clinic, The Netherlands

Other Identifiers

CaIX

Identifier Type: -

Identifier Source: secondary_id

[18F]VM4-037

Identifier Type: -

Identifier Source: org_study_id