PET Study to Study Tumour Apoptosis

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01428440
• Other study ID #: 113236
• Status: Terminated
• Phase: Phase 2
• First received: August 25, 2011
• Last updated: January 11, 2017
• Start date: December 2009
• Est. completion date: July 2011

Study information

• Verified date: January 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Radiation:
• 18FML10
apoptosis imaging radio ligand

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	London

Sponsors (3)

Lead Sponsor	Collaborator
GlaxoSmithKline	Guys St Thomas Hospital, Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apoptosis imaging	Evaluate feasibility of apoptosis imaging with [18F]ML10 PET/CT in	2.5 years
Secondary	[18F]ML10 tumour uptake	To explore the relationship between [18F]ML10 tumour uptake and tissue markers	2.5 years
Secondary	Image optimisation time	To identify an optimal image acquisition time relative to treatment	2.5 years
Secondary	Develop Imaging protocols	To develop simplified imaging protocols for future drug development studies	2.5 years
Secondary	serum markers	To explore the potential role of serum markers in relation to imaging	2.5 years
Secondary	Oncology patients	To evaluate oncology patient compliance and attitudes to imaging studies	2.5 years