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Evaluation of 4D-contrast Enhanced PET-CT in Tumour Volume Definition

Primary Purpose

Lung Carcinoma, Lower Oesophageal Carcinoma, Pancreatic Carcinoma

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
4D PET-CT Scan
No intervention
Sponsored by
The Leeds Teaching Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Lung Carcinoma

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All Sexes

Inclusion Criteria:

  • Age ≥18
  • WHO Performance status 02 (Appendix A)
  • Histologically proven non small cell lung carcinoma, distal oesophageal carcinoma or pancreatic adenocarcinoma
  • Clinical decision made to proceed with a course of radiotherapy of curative intent with or without concurrent chemotherapy
  • Measurable primary tumour and/or locoregional metastatic lymph nodes on preradiotherapy imaging
  • 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:

  1. Hypersensitivity to Fluorine18 fludeoxyglucose (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. Claustrophobia precluding imaging
  6. Uncontrolled pain
  7. Urinary incontinence
  8. Female patients must not be pregnant and if of child bearing age using adequate contraception
  9. Breast feeding
  10. Serious psychiatric comorbidity

Sites / Locations

  • Leeds Teaching Hospitals NHS TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Routine CT scan plus 4D PET-CT scan

Routine CT scan

Arm Description

Outcomes

Primary Outcome Measures

Whole body 4D PET-CT for improved Target Definition/Delineation (feasibility and benefit) (ability to identify the cancer and ability to show areas within the cancer that are potentially more active allowing target of higher dose to these areas)
To evaluate the feasibility and potential benefit of utilising 4D PET-CT for improved Target Definition/Delineation and to assess optimal segmentation of PET data

Secondary Outcome Measures

Full Information

First Posted
October 21, 2014
Last Updated
November 6, 2014
Sponsor
The Leeds Teaching Hospitals NHS Trust
Collaborators
The Leeds Teaching Hospitals Charitable Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02285660
Brief Title
Evaluation of 4D-contrast Enhanced PET-CT in Tumour Volume Definition
Official Title
Evaluation of 4D-contrast Enhanced PET-CT in Tumour Volume Definition for Patients With Lung, Lower Oesophageal and Pancreatic Carcinomas.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
The aim of high dose radiotherapy treatment is to deliver enough radiation to the tumour to kill all the cancer cells while at the same time giving a low dose of radiation to the normal parts of the body to reduce the side effects of treatment. This requires the cancer specialist to accurately identify the areas of cancer on a computed tomography (CT) scan. Positron emission tomography computed tomography (PETCT) scans use radioactive sugar that is injected into the patient. This sugar goes into cancer cells and shows up as a bright spot on the PET scan, allowing the doctors to see tumours more accurately. Some cancers move with breathing, for example lung, pancreas and oesophageal (or gullet) cancers. Fourdimensional CT scanning (4DCT) is a special type of CT scan that allows the motion of the tumour to be seen and measured accurately. This information can then be used to help ensure that the radiotherapy correctly treats the moving tumour. The aim of this study is to see if there are possible benefits to combining PET with 4DCT to get a 4D PETCT scan for tumours that move with breathing. This study is divided into three cancer types; lung, lower oesophagus and pancreatic cancer. First the investigators are going to test the use of 4D PETCT in the radiotherapy planning of these tumours to see if it helps the doctor to identify the cancer. Secondly, the investigators are going to see if the 4D PETCT helps to show areas within the cancer that are potentially more active. This might then allow us to target a higher dose to these areas, which could potentially improve the chance of controlling and curing the cancer. Patients' standard treatment will not be altered by participating in the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Carcinoma, Lower Oesophageal Carcinoma, Pancreatic Carcinoma

7. Study Design

Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Arm Title
Routine CT scan plus 4D PET-CT scan
Arm Type
Other
Arm Title
Routine CT scan
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
4D PET-CT Scan
Intervention Type
Other
Intervention Name(s)
No intervention
Primary Outcome Measure Information:
Title
Whole body 4D PET-CT for improved Target Definition/Delineation (feasibility and benefit) (ability to identify the cancer and ability to show areas within the cancer that are potentially more active allowing target of higher dose to these areas)
Description
To evaluate the feasibility and potential benefit of utilising 4D PET-CT for improved Target Definition/Delineation and to assess optimal segmentation of PET data
Time Frame
Up to two hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Eligibility Criteria
Inclusion Criteria: Age ≥18 WHO Performance status 02 (Appendix A) Histologically proven non small cell lung carcinoma, distal oesophageal carcinoma or pancreatic adenocarcinoma Clinical decision made to proceed with a course of radiotherapy of curative intent with or without concurrent chemotherapy Measurable primary tumour and/or locoregional metastatic lymph nodes on preradiotherapy imaging 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 fludeoxyglucose (FDG) Hypersensitivity to iodinated contrast media Poorly controlled diabetes Acute renal failure or moderate renal impairment (estimated glomerular filtration rate < 30 mL/min) Claustrophobia precluding imaging 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
Andrew Scarsbrook
Phone
01132068212
Email
andrew.scarsbrook@leedsth.nhs.uk
Facility Information:
Facility Name
Leeds Teaching Hospitals NHS Trust
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Scarsbrook
Phone
01132068212
Email
andrew.scarsbrook@leedsth.nhs.uk

12. IPD Sharing Statement

Citations:
PubMed Identifier
28978306
Citation
Scarsbrook A, Ward G, Murray P, Goody R, Marshall K, McDermott G, Prestwich R, Radhakrishna G. Respiratory-gated (4D) contrast-enhanced FDG PET-CT for radiotherapy planning of lower oesophageal carcinoma: feasibility and impact on planning target volume. BMC Cancer. 2017 Oct 4;17(1):671. doi: 10.1186/s12885-017-3659-9.
Results Reference
derived

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Evaluation of 4D-contrast Enhanced PET-CT in Tumour Volume Definition

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