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

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

NCT00935142

Sponsor

Maastricht Radiation Oncology

Status

Withdrawn

Last Update Posted

Jan 25, 2013Estimated

Enrollment

0Actual

Phase

Phase 1

Conditions

Stage 4 Cancer

Interventions

[18F]VM4-037

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
CaIX

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Nov 2012Actual

Completion Date

Nov 2012Actual

First Submitted Date

Jun 30, 2009

First Submission Date that Met QC Criteria

Jul 7, 2009

First Posted Date

Jul 8, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 24, 2013

Last Update Posted Date

Jan 25, 2013Estimated

Name	Class
Maastricht University Medical Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
[18F]VM4-037	Drug	Bolus IV injection of [18F]VM4-037

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Toxicity (CTCAE 3.0)		1 week

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Philippe Lambin, MD. PhD.	Maastro Clinic, The Netherlands	Principal Investigator

ID	Term
D009369	Neoplasms

Intervention Browse Module

MeSH Terms

ID	Term
C000598170	3-(4-(2-fluoroethoxy)phenyl)-2-(3-methyl-2-(4-((2-sulfamoylbenzo(d)thiazol-6-yloxy)methyl)-1H-1,2,3-triazol-1-yl)butanamido)propanoic acid

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided