A pilot study to investigate how best to integrate a PET-CT scan into the radiotherapy planning pathway for lymphoma
| ISRCTN | ISRCTN46587767 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46587767 |
| Secondary identifying numbers | RD12/10519 |
- Submission date
- 22/06/2016
- Registration date
- 28/06/2016
- Last edited
- 10/07/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Robin Prestwich
Scientific
Scientific
Level 4 Bexley Wing
St. James's Institute of Oncology
Beckett Street
Leeds
LS9 7TF
United Kingdom
Study information
| Study design | Single centre non-randomised interventional pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A pilot study to optimise the use of FDG PET-CT and deformable image co-registration for lymphoma radiotherapy planning |
| Study objectives | 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(s) | NRES Committee Yorkshire & The Humber - Leeds East, 24/05/2013, ref: 13/YH/0139 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | - |
| Primary outcome measure | 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 study start date | 01/01/2013 |
| Completion date | 31/12/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 20 |
| Total final enrolment | 19 |
| Key inclusion criteria | 1. Age ≥18 years 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 |
| Key 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 |
| Date of first enrolment | 12/08/2013 |
| Date of final enrolment | 31/12/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Leeds Cancer Centre
Beckett Street
Leeds
LS9 7TF
United Kingdom
Leeds
LS9 7TF
United Kingdom
Sponsor information
Leeds Teaching Hospitals NHS Trust
Hospital/treatment centre
Hospital/treatment centre
R&D Department, Leeds Teaching Hospitals NHS Trust
34 Hyde Terrace
Leeds
LS2 9LN
England
United Kingdom
"ROR" |
https://ror.org/00v4dac24 |
|---|
Funders
Funder type
Hospital/treatment centre
The Leeds Teaching Hospitals Charitable Foundation
No information available
Results and Publications
| Intention to publish date | 01/01/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The main study results will be prepared for presentation and publication in a peer reviewed journal. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 06/09/2018 | 10/07/2023 | Yes | No |
Editorial Notes
10/07/2023: Publication reference and total final enrolment added.
13/07/2016: Internal review.
