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An Open-label Study to Evaluate the Utility of the Apoptosis Imaging Biomarker 18F]ML10 to Assess the Response to Chemotherapy in Patients With Non-Hodgkin's Lymphoma(NHL).


N/A
18 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

An Open-label Study to Evaluate the Utility of the Apoptosis Imaging Biomarker 18F]ML10 to Assess the Response to Chemotherapy in Patients With Non-Hodgkin's Lymphoma(NHL).


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 agents. A biomarker that could permit imaging levels of ongoing apoptosis could
be a powerful tool in associated drug development programs by providing relevant data to
support proof of concept. In addition, use in the clinical setting may permit the tailoring
of treatment for individual patients balancing efficacy of treatment with known toxicity
levels. 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 Hodgkin's Lymphoma. All patients will have a baseline [18F]ML10 PET-CT
scan and a post-treatment scan after the initiation of the first course of intravenous
chemotherapy. The study aims to enrol unto 16 subjects with Non-Hodgkins Lymphoma.


Inclusion Criteria:



1. Capable of giving written informed consent, and willing and able to comply with the
requirements and restrictions listed in the consent form.

2. 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

3. A female subject is eligible to participate if she has non-childbearing potential

4. Male subject must agree to use one of the contraception methods listed

5. Able to lie comfortably on back for up to 70 minutes at a time.

6. WHO performance status 0, 1 or 2 -

Exclusion Criteria:

1. Patients with known history of Hepatitis B, C, non-A, non-B and HIV

2. Any clinically significant medical conditions that in the opinion of the investigator
would compromise the compliance with study procedures.

3. Pregnant or breast feeding females.

4. Any other prior anticancer therapy

5. Any new investigational agent, including an investigational anti-cancer agent

6. History of sensitivity to heparin or heparin-induced thrombocytopenia.

7. Males and females not able to comply with contraceptive guidelines during the study.

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Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

changes in [18F]ML10 uptake in tumours

Outcome Description:

Extent of changes in [18F]ML10 uptake in tumours following chemotherapy using visual and semi-quantitative parameters.

Outcome Time Frame:

between baseline at day 0 and between 14-20 days after

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United Kingdom: Research Ethics Committee

Study ID:

114238

NCT ID:

NCT01476085

Start Date:

July 2011

Completion Date:

October 2011

Related Keywords:

  • Cancer
  • Lymphoma
  • Lymphoma, Non-Hodgkin

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