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

Non Invasive Imaging of [18F]VM4-037 With Positron-Emission-Tomography (PET): A Phase I Trial

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00935142

Acronym

[18F]VM4-037

Enrollment

Registered

2009-07-08

Start date

2012-01-31

Completion date

2012-11-30

Last updated

2013-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stage 4 Cancer

Keywords

stage IV cancer with no treatment options, non-curative

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

Interventions

DRUG[18F]VM4-037

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Toxicity (CTCAE 3.0)	1 week

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026