Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RD12/10519
Study information
Scientific title
A pilot study to optimise the use of FDG PET-CT and deformable image co-registration for lymphoma radiotherapy planning
Acronym
Study hypothesis
Study aim is to evaluate the impact of pre-chemotherapy PET-CT performed in the radiotherapy treatment position upon the accuracy of subsequent radiotherapy target volume definition
Ethics approval
NRES Committee Yorkshire & The Humber - Leeds East, 24/05/2013, ref: 13/YH/0139
Study design
Single centre non-randomised interventional pilot study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
High grade lymphoma
Intervention
The study aims to recruit up to 20 patients with early stage Hodgkin lymphoma or high grade non-Hodgkin lymphoma. A routine staging PET-CT will be followed at the same session by a PET-CT in the radiotherapy treatment position appropriate radiotherapy immobilisation devices.
Participation in the study will not affect treatment decisions or the radiotherapy planning process. The process of planning radiotherapy will not be systematically altered by the study.
Intervention type
Device
Phase
Drug names
Primary outcome measures
The impact of pre-chemotherapy PET-CT performed in the radiotherapy treatment position upon the subsequent radiotherapy target volume on retrospective analysis. (This will not alter routine treatment for participants). This endpoint will be evaluated using methods of positional analysis to compare radiotherapy target volumes that are constructed with and without the benefit of the PET-CT acquired in the radiotherapy position.
Secondary outcome measures
To assess the accuracy of image coregistration between pre-chemotherapy PET-CT and the post-chemotherapy planning CT scan.
Overall trial start date
01/01/2013
Overall trial end date
31/12/2017
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age ≥18
2. WHO Performance status 0-2 (Appendix A)
3. Histologically proven Hodgkin lymphoma or high grade non-Hodgkin lymphoma
4. Ann Arbor Stage I/II disease based upon clinical examination and any radiology investigations performed
5. Clinical decision to proceed with sequential chemotherapy and radiotherapy if stage I/II disease is confirmed on subsequent PET-CT staging
6. Residual disease in situ after biopsy (either palpable or on any imaging acquired pre-PET-CT)
7. Able to provide fully informed written consent
8. Able to lie flat for 1 hour
9. Not be pregnant or breast feeding. Female patients of childbearing potential must agree to use effective contraception, be surgically sterile, or be post-menopausal
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20
Participant exclusion criteria
1. Hypersensitivity to 18Fluorine-FDG
2. Hypersensitivity to iodinated contrast media
3. Poorly controlled diabetes
4. Acute renal failure or moderate renal impairment (estimated glomerular filtration rate < 30 mL/min)
5. Uncontrolled pain
6. Urinary incontinence
7. Female patients must not be pregnant and if of child bearing age using adequate contraception
8. Breast feeding
9. Serious psychiatric comorbidity
Recruitment start date
12/08/2013
Recruitment end date
31/12/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Leeds Cancer Centre
Beckett Street
Leeds
LS9 7TF
United Kingdom
Funders
Funder type
Hospital/treatment centre
Funder name
The Leeds Teaching Hospitals Charitable Foundation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The main study results will be prepared for presentation and publication in a peer reviewed journal.
Intention to publish date
01/01/2017
Participant level data
Available on request
Results - basic reporting
Publication summary