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

Phase 1
18 Years
Not Enrolling
Stage 4 Cancer

Thank you

Trial Information

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

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

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Toxicity (CTCAE 3.0)

Outcome Time Frame:

1 week

Safety Issue:


Principal Investigator

Philippe Lambin, MD. PhD.

Investigator Role:

Principal Investigator

Investigator Affiliation:



Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:




Start Date:

January 2012

Completion Date:

November 2012

Related Keywords:

  • Stage 4 Cancer
  • stage IV cancer with no treatment options
  • non-curative