Status:
TERMINATED
Evaluating the Utility of the Apoptosis Imaging Biomarker 18F]ML10 in Patients With Non-Hodgkin's Lymphoma(NHL)
Lead Sponsor:
GlaxoSmithKline
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study aims to evaluate the potential of 2-(5- Fluoro pentyl)-2-methyl malonic acid (\[18F\]ML10), as an apoptosis imaging biomarker and its potential to predict response in patients with Non Hodg...
Detailed Description
Apoptosis or programmed cell death mechanisms are disrupted in cancer cells allowing them to live longer and grow faster than normal cells. Apoptosis is a key target for several novel anti-cancer agen...
Eligibility Criteria
Inclusion
- Capable of giving written informed consent, and willing and able to comply with the requirements and restrictions listed in the consent form.
- Male or female patients \>18 years of age at screening with histological or cytological diagnosis of Non-Hodgkin's Lymphoma and due to receive intravenous chemotherapy for the first time
- A female subject is eligible to participate if she has non-childbearing potential
- Male subject must agree to use one of the contraception methods listed
- Able to lie comfortably on back for up to 70 minutes at a time.
- WHO performance status 0, 1 or 2 -
Exclusion
- Patients with known history of Hepatitis B, C, non-A, non-B and HIV
- Any clinically significant medical conditions that in the opinion of the investigator would compromise the compliance with study procedures.
- Pregnant or breast feeding females.
- Any other prior anticancer therapy
- Any new investigational agent, including an investigational anti-cancer agent
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Males and females not able to comply with contraceptive guidelines during the study.
- \-
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01476085
Start Date
July 1 2011
End Date
October 1 2011
Last Update
July 1 2013
Active Locations (1)
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1
GSK Investigational Site
London, London, United Kingdom, W12 0NN