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

Stage 4 Cancer Clinical Trial

— [18F]VM4-037  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00935142
• Other study ID #: [18F]VM4-037
• Secondary ID: CaIX
• Status: Withdrawn
• Phase: Phase 1
• First received: June 30, 2009
• Last updated: January 24, 2013
• Start date: January 2012
• Est. completion date: November 2012

Study information

• Verified date: January 2013
• Source: Maastricht Radiation Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Stage 4 Cancer

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht Radiation Oncology	Maastricht University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity (CTCAE 3.0)		1 week	Yes
Secondary	Image Quality		1 week	No
Secondary	Correlation with circulating biomarkers of hypoxia		1 week	No
Secondary	Correlation with [18F]-FDG on PET scans		1 week	No