Non-invasive Imaging With [18F]VM4-037 (NCT00935142)

Study 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 studied

Stage 4 Cancer

Keywords

stage IV cancer with no treatment options
non-curative

In context

Lead sponsor

Maastricht Radiation Oncology is the lead sponsor of 104 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 1
Primary purpose: Diagnostic
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 0 participants (actual)

Interventions

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

What researchers measure

Primary outcomes

Toxicity (CTCAE 3.0)
Time frame: 1 week

Secondary outcomes

Image Quality
Time frame: 1 week
Correlation with circulating biomarkers of hypoxia
Time frame: 1 week
Correlation with [18F]-FDG on PET scans
Time frame: 1 week

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 25, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00935142
Lead sponsor: Maastricht Radiation Oncology
Collaborators: Maastricht University Medical Center
Responsible party: Sponsor
First posted: Jul 8, 2009
Start date: Jan 2012
Primary completion: Nov 2012
Completion: Nov 2012
Last update: Jan 25, 2013

Study contacts

Philippe Lambin, MD. PhD.

principal investigator · Maastro Clinic, The Netherlands

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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Discussion

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