PET Study to Study Tumour Apoptosis

NCT ID: NCT01428440

Last Updated: 2017-01-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2011-07-31

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.

Conditions

Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

no treatment

Group Type: OTHER

18FML10

Intervention Type: RADIATION

apoptosis imaging radio ligand

Interventions

18FML10

apoptosis imaging radio ligand

Intervention Type: RADIATION

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role: collaborator

Imperial College London

OTHER

Sponsor Role: collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

London, London, United Kingdom

GSK Investigational Site

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

113236

Identifier Type: -

Identifier Source: org_study_id