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PET Study to Study Tumour Apoptosis

This study has been completed.
Sponsor:
Collaborators:
Guys St Thomas Hospital
Imperial College London
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01428440
First received: August 25, 2011
Last updated: July 19, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention
Cancer
 Radiation: 18FML10

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Positron Emission Tomography (PET) Study to Evaluate 18FML10 as an Imaging Agent for Tumour Apoptosis

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Apoptosis imaging [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
    Evaluate feasibility of apoptosis imaging with [18F]ML10 PET/CT in


Secondary Outcome Measures:
  • [18F]ML10 tumour uptake [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
    To explore the relationship between [18F]ML10 tumour uptake and tissue markers

  • Image optimisation time [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
    To identify an optimal image acquisition time relative to treatment

  • Develop Imaging protocols [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
    To develop simplified imaging protocols for future drug development studies

  • serum markers [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
    To explore the potential role of serum markers in relation to imaging

  • Oncology patients [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
    To evaluate oncology patient compliance and attitudes to imaging studies


Biospecimen Retention:   Samples Without DNA

Blood samples to be taken for measurement of radioactivity and tumour biopsies taken also.


Enrollment: 24
Study Start Date: December 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
no treatment
none
 Radiation: 18FML10
apoptosis imaging radio ligand

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients included in this imaging study will come from four tumour groups - breast cancer, ovarian cancer, NHL and small cell lung cancer and planned to receive chemotherapy as their treatment.

Patients with PET-imageable tumour lesions (> 2cm) will be identified. Only patients who have been clinically worked up and deemed fit to receive chemotherapy will be approached to take part in the study.

Patients will be identified at multidisciplinary meetings and at specialist clinics at the Imperial College Healthcare NHS Trust (Hammersmith Hospital, Charing Cross Hospital), London, Guys and St Thomas Hospitals, London or associated hospitals where the clinical co-investigators have clinical duties.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01428440

Locations
United Kingdom
GSK Investigational Site
London, United Kingdom, W12 0NN
Sponsors and Collaborators
GlaxoSmithKline
Guys St Thomas Hospital
Imperial College London
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01428440     History of Changes
Other Study ID Numbers: 113236
Study First Received: August 25, 2011
Last Updated: July 19, 2012
Health Authority: United Kingdom: Ethics Committee

ClinicalTrials.gov processed this record on May 22, 2013