PET Study to Study Tumour Apoptosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01428440
Recruitment Status : Terminated (The study was terminated early as the results did not support study objectives and were not as significant as expected.)
First Posted : September 5, 2011
Last Update Posted : January 12, 2017
Guys St Thomas Hospital
Imperial College London
Information provided by (Responsible Party):

Brief Summary:
Apoptosis or programmed cell death is disrupted in cancer cells allowing them to live longer. A number of anti-cancer agents induce apoptosis as a mechanism of drug action to get rid of cancers. A biomarker that would allow apoptosis in tumours to be imaged directly would provide a powerful new tool for oncology drug development and potentially contribute to improved patient care. In this study, we propose to evaluate [18F]ML10-PET for imaging tumour apoptosis in patients receiving standard chemotherapy treatment for their cancer.

Condition or disease Intervention/treatment Phase
Cancer Radiation: 18FML10 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Positron Emission Tomography (PET) Study to Evaluate 18FML10 as an Imaging Agent for Tumour Apoptosis
Study Start Date : December 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
no treatment Radiation: 18FML10
apoptosis imaging radio ligand

Primary Outcome Measures :
  1. Apoptosis imaging [ Time Frame: 2.5 years ]
    Evaluate feasibility of apoptosis imaging with [18F]ML10 PET/CT in

Secondary Outcome Measures :
  1. [18F]ML10 tumour uptake [ Time Frame: 2.5 years ]
    To explore the relationship between [18F]ML10 tumour uptake and tissue markers

  2. Image optimisation time [ Time Frame: 2.5 years ]
    To identify an optimal image acquisition time relative to treatment

  3. Develop Imaging protocols [ Time Frame: 2.5 years ]
    To develop simplified imaging protocols for future drug development studies

  4. serum markers [ Time Frame: 2.5 years ]
    To explore the potential role of serum markers in relation to imaging

  5. Oncology patients [ Time Frame: 2.5 years ]
    To evaluate oncology patient compliance and attitudes to imaging studies

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female patients >18 years of age at screening with histological or cytological diagnosis of non-Hodgkin's lymphoma, small cell lung cancer, breast or ovarian cancer who have been worked up clinically (see below) and due to receive standard chemotherapy treatment, but enrolled prior to the initiation of chemotherapy.
  • A female subject is eligible to participate if she is of non-childbearing potential or if she is of childbearing potential and agrees to use one of the contraception methods listed. Male subjects are eligible to participate if he also agrees to use one of the contraception methods listed.
  • Tumour that is considered by the investigator to be able to be imaged using PET (about 2cm in size or more)
  • Able to lie comfortably on back for up to 65 minutes at a time.
  • Capable of giving written informed consent, and willing and able to comply with the requirements and restrictions listed in the consent form.
  • Patients deemed to be fit to receive chemotherapy treatment by their oncologist.
  • WHO performance status 0, 1 or 2.

Exclusion Criteria:

  • Any medical or psychiatric diagnoses or symptoms or social situations that in the view of the investigator would limit compliance with study requirements.
  • Pregnant or breast feeding females.
  • Received any other anticancer therapy (radiotherapy, chemotherapy, or immunotherapy) or any other investigational agent, including an investigational anti-cancer agent within 28 days prior to the first [18F]ML10-PET scan.
  • History of sensitivity to heparin or heparin-induced thrombocytopenia.
  • Inability to comply with contraceptive guidelines during the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01428440

United Kingdom
GSK Investigational Site
London, United Kingdom, SE1 9RT
GSK Investigational Site
London, United Kingdom, W12 0NN
Sponsors and Collaborators
Guys St Thomas Hospital
Imperial College London
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline Identifier: NCT01428440     History of Changes
Other Study ID Numbers: 113236
First Posted: September 5, 2011    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: January 2017