Condition category
Cancer
Date applied
22/06/2016
Date assigned
28/06/2016
Last edited
13/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Robin Prestwich

ORCID ID

Contact details

Level 4 Bexley Wing
St. James's Institute of Oncology
Beckett Street
Leeds
LS9 7TF
United Kingdom

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

Sponsor information

Organisation

Leeds Teaching Hospitals NHS Trust

Sponsor details

R&D Department
Leeds Teaching Hospitals NHS Trust
34 Hyde Terrace
Leeds
LS2 9LN
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes

13/07/2016: Internal review.