A pilot study to investigate how best to integrate a PET-CT scan into the r... | Not Recruiting
A pilot study to investigate how be... | Not Recruiting
A pilot study to investigate how best to integrate a PET-CT scan into the radiotherapy planning pathway for lymphoma

Location not identified by Google services

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Medical Conditions
  • High grade lymphoma
Primary Contact Details
Dr Robin Prestwich
See all trial contact details
Recruitment Status
Not Recruiting
Trial source and source ID number
ISRCTN46587767
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
Not provided at time of registration
Research Details
  • 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
Phase
Sorry, this information is not available
Study Design
Single centre non-randomised interventional pilot study
Study Type
Interventional
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
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.
Publication(s)
Sorry, this information is not available
Result Reports
Sorry, this information is not available
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
Adult
Who Can Participate
Patient
Number of Participants
20
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 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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Leeds
LS9 7TF
Trial Contact(s)
Primary Trial Contact
Dr Robin Prestwich
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A pilot study to optimise the use of FDG PET-CT and deformable image co-registration for lymphoma radiotherapy planning
EudraCT Number
Sorry, this information is not available
Funder(s)
  • The Leeds Teaching Hospitals Charitable Foundation
Other Study ID Numbers
RD12/10519
Sponsor(s)
Leeds Teaching Hospitals NHS Trust
Key Dates

Recruitment Start Date

12 Aug 2013

Recruitment End Date

31 Dec 2016

Trial Start Date

01 Jan 2013

Trial End Date

31 Dec 2017

Date added to source

28 Jun 2016

Date updated in source

13 Jul 2016