Clinical trial NCT01428440: PET Study to Study Tumour Apoptosis
Official title: A Positron Emission Tomography (PET) Study to Evaluate 18FML10 as an Imaging Agent for Tumour Apoptosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cancer
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: Guy's and St Thomas' NHS Foundation Trust
name: Imperial College London
First posted: 2011-09-05
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Apoptosis imaging
timeFrame: 2.5 years
Secondary outcomes:
measure: [18F]ML10 tumour uptake
timeFrame: 2.5 years
measure: Image optimisation time
timeFrame: 2.5 years
measure: Develop Imaging protocols
timeFrame: 2.5 years
measure: serum markers
timeFrame: 2.5 years
measure: Oncology patients
timeFrame: 2.5 years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: