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FDG PET-CT for Lymphoma Radiotherapy Planning Version 1.3

Primary Purpose

Improve the Radiotherapy Planning Process

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Radiotherapy
Sponsored by
The Leeds Teaching Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Improve the Radiotherapy Planning Process

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • 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

Sites / Locations

  • The Leeds Teaching Hospitals NHS TrustRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pilot

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 20, 2013
Last Updated
May 18, 2015
Sponsor
The Leeds Teaching Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01999998
Brief Title
FDG PET-CT for Lymphoma Radiotherapy Planning Version 1.3
Official Title
A Pilot Study to Optimise the Use of FDG PET-CT and Deformable Image Co-registration for Lymphoma Radiotherapy Planning
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
April 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Leeds Teaching Hospitals NHS Trust

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Improve the Radiotherapy Planning Process

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pilot
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robin Prestwich, PhD, FRCR, MRCP, BMBCh
Email
Robin.Prestwich@leedsth.nhs.uk
Facility Information:
Facility Name
The Leeds Teaching Hospitals NHS Trust
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robin Prestwich, PhD, FRCR, MRCP, BMBCh

12. IPD Sharing Statement

Learn more about this trial

FDG PET-CT for Lymphoma Radiotherapy Planning Version 1.3

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