PET Study to Study Tumour Apoptosis

Phase 2

Terminated

• Conditions: Cancer
• Interventions: Radiation: 18FML10

• Registration Number: NCT01428440
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Study First Submitted: 2011-08-25
• Study First Submitted QC: 2011-09-01
• Study First Posted: 2011-09-05
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
no treatment	18FML10	-

Primary Outcome Measures

Name	Time	Method
Apoptosis imaging	2.5 years	Evaluate feasibility of apoptosis imaging with \[18F\]ML10 PET/CT in

Secondary Outcome Measures

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

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 London, United Kingdom