Evaluation Of 4D-contrast Enhanced PET-CT In Tumour Volume Definition

Study Overview

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

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.

N/A

Lung Carcinoma
Lower Oesophageal Carcinoma
Pancreatic Carcinoma

PROCEDURE: 4D PET-CT Scan
OTHER: No intervention

RD11/9711
11/YH/0213 (OTHER Identifier) (OTHER: Research Ethics Committee)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2014-10-21	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2014-11-06
First Submitted that Met QC Criteria 2014-11-06	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2014-11-07
First Posted (ESTIMATED) 2014-11-07	Results First Posted N/A	Last Verified 2014-11

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
OTHER: Routine CT scan plus 4D PET-CT scan	PROCEDURE: 4D PET-CT Scan
OTHER: Routine CT scan	PROCEDURE: 4D PET-CT Scan OTHER: No intervention

Participant Group/Arm

Intervention/Treatment

OTHER: Routine CT scan plus 4D PET-CT scan

PROCEDURE: 4D PET-CT Scan

OTHER: Routine CT scan

PROCEDURE: 4D PET-CT Scan

OTHER: No intervention

Primary Outcome Measures	Measure Description	Time Frame
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	Up to two hours

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Andrew Scarsbrook

Phone Number: 01132068212

Email: andrew.scarsbrook@leedsth.nhs.uk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

The Leeds Teaching Hospitals Charitable Foundation

Investigators

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Learn

Resources

Patients

Caregivers

Clinical Trial Record