Last updated: 11/03/2018 14:44:41
PET study to study tumour apoptosis
GSK study ID
113236
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
Official title: A Positron Emission Tomography (PET) Study to evaluate 18FML10 as an imaging agent for tumour apoptosis
Trial description: Apoptosis or programmed cell death is disrupted in cancer cells allowingthem to live longer. A number of anti-cancer agents induce apoptosis as a mechanism ofdrug action to get rid of cancers. A biomarker that would allow apoptosis in tumours tobe imaged directly would provide a powerful new tool for oncology drug developmentand potentially contribute to improved patient care. In this study, we propose to evaluate[18F]ML10-PET for imaging tumour apoptosis in patients receiving standardchemotherapy treatment for their cancer.
Primary purpose:
Diagnostic
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
[18F]ML10 tumour and normal tissue uptake for each positron emission tomography (PET) scan expressed as Standardised uptake value (SUV)
Timeframe: Up to 2.5 years
Secondary outcomes:
Correlation between [18F]ML10 tumor uptake and tissue apoptotic markers
Timeframe: Up to 2.5 years
Time course of [18F]ML10 PET signal for each PET scan
Timeframe: Up to 2.5 years
[18F]ML10 tissue uptake parameter-Area under the time-activity curve (AUC)
Timeframe: Up to 2.5 years
[18F]ML10 tissue uptake parameter-Maximal tissue radioactivity (Cmax)
Timeframe: Up to 2.5 years
[18F]ML10 tissue uptake parameter-Time to reach maximal activity (Tmax)
Timeframe: Up to 2.5 years
Correlation between surrogate serum markers of apoptosis and uptake of [18F]ML10
Timeframe: Up to 2.5 years
Assessment of participant study evaluation questionnaires
Timeframe: Up to 2.5 years
Interventions:
Enrollment:
7
Primary completion date:
2011-22-07
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Cancer
Product
Not applicable
Collaborators
Guys St Thomas Hospital, Imperial College London
Study date(s)
December 2009 to July 2011
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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.
- 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.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
London, London, United Kingdom, W12 0NN
Status
Study Complete
Study documents
No study documents available.
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Other
Actual primary completion date
2011-22-07
Actual study completion date
2011-22-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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