Last updated: 11/03/2018 16:21:56

Evaluating the utility of the apoptosis imaging biomarker 18F]ML10 in patients with Non-Hodgkin's Lymphoma(NHL)

GSK study ID
114238
Clinicaltrials.gov ID
NCT01476085
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: 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).
Trial description: 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.
Primary purpose:
Diagnostic
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

changes in [18F]ML10 uptake in tumours

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

Secondary outcomes:

alterations in [18F]ML10 uptake with tumour volume and tumour metabolic changes

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

voxel-based uptake map of [18F]ML10 in the target lesion

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

Interventions:
  • Radiation: ML10
    • Enrollment:
    1
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Cancer
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    July 2011 to July 2011
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • 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
    • 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.
    Inclusion and exclusion criteria
    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. -

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    London, London, United Kingdom, W12 0NN
    Status
    Study Complete
    Contact us

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Other
    Actual primary completion date
    Not applicable
    Actual study completion date
    2011-26-07

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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