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A pilot study to investigate how best to integrate a PET-CT scan into the radiotherapy planning pathway for lymphoma

A pilot study to optimise the use of FDG PET-CT and deformable image co-registration for lymphoma radiotherapy planning

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN46587767
Enrollment
20
Registered
2016-06-28
Start date
2013-08-12
Completion date
Unknown
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High grade lymphoma Cancer

Interventions

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 radio

Sponsors

Leeds Teaching Hospitals NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
To assess the accuracy of image coregistration between pre-chemotherapy PET-CT and the post-chemotherapy planning CT scan.

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026