PET Study to Study Tumour Apoptosis

Study Overview
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Brief Summary
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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.

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

Conditions
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Cancer

Intervention / Treatment
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* Radiation: 18FML10


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: no treatment<br> | Radiation: 18FML10<br>* apoptosis imaging radio ligand<br>|

What is the study measuring?
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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 |