PET Study to Study Tumour Apoptosis

A Positron Emission Tomography (PET) Study to Evaluate 18FML10 as an Imaging Agent for Tumour Apoptosis

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.

Study Overview

• Status: Terminated
• Conditions: Cancer
• Intervention / Treatment: Radiation: 18FML10

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 9RT
    • GSK Investigational Site
  • London, United Kingdom, W12 0NN
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: no treatment	Radiation: 18FML10; apoptosis imaging radio ligand

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apoptosis imaging	Evaluate feasibility of apoptosis imaging with [18F]ML10 PET/CT in	2.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
[18F]ML10 tumour uptake	To explore the relationship between [18F]ML10 tumour uptake and tissue markers	2.5 years
Image optimisation time	To identify an optimal image acquisition time relative to treatment	2.5 years
Develop Imaging protocols	To develop simplified imaging protocols for future drug development studies	2.5 years
serum markers	To explore the potential role of serum markers in relation to imaging	2.5 years
Oncology patients	To evaluate oncology patient compliance and attitudes to imaging studies	2.5 years

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Collaborators: Imperial College London; Guy's and St Thomas' NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: August 25, 2011
• First Submitted That Met QC Criteria: September 1, 2011
• First Posted (Estimate): September 5, 2011

Study Record Updates

• Last Update Posted (Estimate): January 12, 2017
• Last Update Submitted That Met QC Criteria: January 11, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 113236