ClinicalTrials.gg
Status unknownNCT01999998Updated May 19, 2015

FDG PET-CT for Lymphoma Radiotherapy Planning Version 1.3

An interventional study of Radiotherapy in Improve the Radiotherapy Planning Process, sponsored by The Leeds Teaching Hospitals NHS Trust. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-19.

Sponsored by The Leeds Teaching Hospitals NHS Trust · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

Chemotherapy followed by radiotherapy is used to treat early stage lymphomas with excellent cure rates. However, a significant proportion of these patients develop cancers and heart diseases years later as a result of the radiotherapy. Therefore, there is a move to reduce radiation exposure without compromising cure rates. Radiotherapy is planned using a CT scan taken following chemotherapy when many of the original sites of the lymphoma are no longer visible using a CT scan taken following chemotherapy when many of the original sites of the lymphoma are no longer visible.

In order to safely minimise the volume treated with radiotherapy it is necessary to accurately reconstruct the extent of the lymphoma prior to chemotherapy on this 'planning' CT scan. A PETCT prior to chemotherapy is the best way of demonstrating the original extent of the lymphoma, but is taken in a different position to the radiotherapy treatment position. This aim of this study is to explore whether a PETCT scan taken prior to chemotherapy in the radiotherapy treatment position, in conjunction with advanced software to combine this scan with the subsequent radiotherapy planning CT, can be used to more accurately identify the lymphoma target. The study aims to recruit up to 20 patients with early stage Hodgkin lymphoma or high grade nonHodgkin lymphoma. A routine staging PETCT will be followed at the same session by a PETCT in the radiotherapy treatment position appropriate radiotherapy immobilisation devices. Participation in the study will not affect treatment decisions or the radiotherapy planning process. The PETCT in the radiotherapy planning position will be made available to the treating clinicians. The process of planning radiotherapy will not be systematically altered by the study. The study is aimed at determining how to improve the radiotherapy planning process in the future, in the hope of a reducing in the long term side effects of treatment whilst retaining high cure rates.

02

Conditions studied

  • Improve the Radiotherapy Planning Process
03

In context

Lead sponsor

The Leeds Teaching Hospitals NHS Trust is the lead sponsor of 100 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥18
  • WHO Performance status 02
  • Histologically proven Hodgkin lymphoma or high grade nonHodgkin lymphoma
  • Ann Arbor Stage I/II disease based upon clinical examination and any radiology investigations performed
  • Clinical decision to proceed with sequential chemotherapy and radiotherapy if stage I/II disease is confirmed on subsequent 18FDGPETCT staging
  • Residual disease in situ after biopsy
  • Able to provide fully informed written consent
  • Able to lie flat for 1 hour
  • Not be pregnant or breast feeding. Female patients of childbearing potential must agree to use effective contraception, be surgically sterile, or be postmenopausal.

Exclusion criteria

Exclusion Criteria:

  • Hypersensitivity to fluorine18 FDG
  • Hypersensitivity to iodinated contrast media or Gadolinium
  • Poorly controlled diabetes
  • Acute renal failure or moderate renal impairment (estimated glomerular filtration rate \< 30 mL/min)
  • Uncontrolled pain
  • Urinary incontinence
  • Female patients must not be pregnant and if of child bearing age using adequate contraception
  • Breast feeding
  • Serious psychiatric comorbidity
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Pilot

    Radiation: Radiotherapy

Interventions

  • RadiationRadiotherapy
06

What researchers measure

Primary outcomes

  1. PETCT scan taken prior to chemotherapy in the radiotherapy treatment position, in conjunction with advanced software to combine this scan with the subsequent radiotherapy planning CT, to more accurately identify the lymphoma target.

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • The Leeds Teaching Hospitals NHS Trust
    Leeds, LS9 7TF, United Kingdom
    • Robin Prestwich, PhD, FRCR, MRCP, BMBCh · Contact
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2013 and a primary completion of Apr 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 20, 2013
First posted
Dec 3, 2013
Start
Aug 2013
Primary completionEst.
Apr 2016
Last update
May 19, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 19, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01999998
Responsible party
Sponsor
First posted
Dec 3, 2013
Start date
Aug 2013
Primary completion
Apr 2016 (estimated)
Last update
May 19, 2015

Study contacts

Robin Prestwich, PhD, FRCR, MRCP, BMBCh
Contact
Robin.Prestwich@leedsth.nhs.uk
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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