- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00935142
Non-invasive Imaging With [18F]VM4-037 ([18F]VM4-037)
January 24, 2013 updated by: Maastricht Radiation Oncology
Non Invasive Imaging of [18F]VM4-037 With Positron-Emission-Tomography (PET): A Phase I Trial
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
Study Overview
Study Type
Interventional
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Toxicity (CTCAE 3.0)
Time Frame: 1 week
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Image Quality
Time Frame: 1 week
|
1 week
|
Correlation with circulating biomarkers of hypoxia
Time Frame: 1 week
|
1 week
|
Correlation with [18F]-FDG on PET scans
Time Frame: 1 week
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Philippe Lambin, MD. PhD., Maastro Clinic, The Netherlands
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (ACTUAL)
November 1, 2012
Study Completion (ACTUAL)
November 1, 2012
Study Registration Dates
First Submitted
June 30, 2009
First Submitted That Met QC Criteria
July 7, 2009
First Posted (ESTIMATE)
July 8, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
January 25, 2013
Last Update Submitted That Met QC Criteria
January 24, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- [18F]VM4-037
- CaIX
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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