Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Dr Anastasia Chalkidou
ORCID ID
Contact details
The Rayne Institute
4th Floor Lambeth Wing
St Thomas Hospital
London
SE1 7EH
United Kingdom
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Anastasia.Chalkidou@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
8495
Study information
Scientific title
Research study of 18-FLT (18F-3'-fluoro-3-deoxy-L-thymidine) positron emission tomography (PET/CT) sequential imaging to quantify tumour proliferation during radical radiotherapy in patients with non-small cell lung cancers and head and neck cancers
Acronym
Study hypothesis
Despite impressive advances in radiotherapy over recent years many tumours are still not cured by radical doses of radiation, partly because tumours respond to radiotherapy by growing more rapidly ('accelerated repopulation'). This makes treatment rather like running down an upward escalator. In this study an imaging technique is investigated that might help us identify whether accelerated repopulation is taking place in individual patients, when it begins, how fast it is progressing, and where in the tumour it is occurring. This could help to individualise patient treatments, both by modifying treatment schedules to minimise repopulation and by selectively raising doses delivered to rapidly repopulating tumour regions - with the aim of curing more patients using radiotherapy.
Twenty patients with either lung cancer or head and neck cancer who are being treated using radiotherapy will undergo a series of 6 positron emission tomography (PET) scans, imaging a novel thymidine-based tracer called fluoro-L-thymidine (FLT). FLT uptake measured in PET images has been found to correlate with levels of a biomarker of proliferation measured in surgical specimens, and is increasingly being investigated as a measure of tumour proliferation in cancer patients. To make the best use of the PET imaging data a set of technical processes will be established so that FLT tracer uptake per voxel can be measured accurately. These complex data will relate to the same parts of the tumour and therefore can be compared consistently across a series of scans. The sequences of PET images collected in the study will be comprehensively analysed exploring the time-course and spatial maps of tumour proliferation.
These data will enable the comparison of the effect of radiotherapy on DNA damage and provide proof of principle data on whether FLT relates to this. These data may then show how radiotherapy can be modified to minimise the scope for accelerated proliferation and target rapidly proliferating tumour regions.
Ethics approval
St Thomas REC, 12/04/2010, (ref: 10/H0802/2
Study design
Single-centre non-randomised interventional trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: National Cancer Research Network; Subtopic: Head and Neck Cancer, Lung Cancer; Disease: non small cell lung cancer
Intervention
1. Arterial line: Arterial line placed in the radial artery by experienced Intensive Care Unit physicians. Blood tests taken from this arterial line.
2. Biopsy material: Ultrasound guided fine needle aspiration for head and neck cancer patients once during radiotherapy.
3. PET/CT scan with new tracer: PET/CT scan with FLT. From injection to end of scanning is about 75 minutes. Undertaken by fully trained PET centre staff.
4. Radiotherapy mask: Radiotherapy mask will be used in head and neck patients to position the patient for the scanning.
5. Venepuncture: Blood test during each PET scan.
Follow-up length: 3 months
Study entry: registration only
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Stability of tumour FLT spatial uptake pattern throughout treatment, measured during treatment and 3 months afterwards.
Secondary outcome measures
1. Average time-course of overall tumour FLT uptake
2. Patient-to-patient differences in FLT uptake time-course
3. Characterisation of typical spatial pattern of tumour FLT uptake
4. Patient-to-patient variability in tumour FLT spatial uptake patterns
5. Relationships between CK-18Asp396 levels in blood and changes in tumour FLT uptake between scans
6. Comparison of FLT kinetics with SUV values
All the secondary outcomes will be measured at baseline, during radiotherapy and at 3 months follow up.
Overall trial start date
17/06/2010
Overall trial end date
31/01/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. About to undergo radical radiotherapy for one of the following:
1.1. Non-small cell lung cancer with staging between I - III and either the primary tumour or an involved lymph node being greater than 3 cm in maximum dimension
1.2. Squamous cell carcinoma of the head and neck region with staging between II - IVA and either the primary tumour or an involved lymph node being greater than 3 cm in maximum dimension
2. Over 18 years of age, either sex
3. Able to understand consent form
4. Fit for extra incovenience of longer stays in hospital on days of scans
5. Receiving chemotherapy concurrently with radiotherapy
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 20; UK sample size: 20
Participant exclusion criteria
1. Patient unfit to attend extra scanning visits
2. Tumour criteria not met
3. Clotting disorder for head and neck group
4. Severe claustrophobia or inability to tolerate PET/CT
5. Unable to provide written consent
6. Pregnant or breastfeeding women
7. Subjects taking nucleoside analog medications such as those used as antiretroviral agents
Recruitment start date
17/06/2010
Recruitment end date
31/01/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Rayne Institute
London
SE1 7EH
United Kingdom
Sponsor information
Organisation
Guy's and St. Thomas' NHS Foundation Trust (UK)
Sponsor details
2nd Floor
Conybeare House
Great Maze Pond
London
SE1 9RT
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK)
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in https://www.ncbi.nlm.nih.gov/pubmed/24694142