Evaluation of 4D-contrast Enhanced PET-CT in Tumour Volume Definition
2 other identifiers
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 21, 2014
CompletedFirst Posted
Study publicly available on registry
November 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedNovember 7, 2014
November 1, 2014
3.5 years
October 21, 2014
November 6, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Routine CT scan plus 4D PET-CT scan
OTHERRoutine CT scan
OTHERInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, LS9 7TF, United Kingdom
Related Publications (1)
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.
PMID: 28978306DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2014
First Posted
November 7, 2014
Study Start
June 1, 2011
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
November 7, 2014
Record last verified: 2014-11