Lung CarcinomaNCT02285660
Evaluation of 4D-contrast Enhanced PET-CT in Tumour Volume Definition
A study testing 4D PET-CT Scan in people with Lung Carcinoma and Lower Oesophageal Carcinoma, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lung Carcinoma, Lower Oesophageal Carcinoma, Pancreatic Carcinoma
- What is being tested?
- 4D PET-CT Scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2011to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- Urinary incontinence
- Female patients must not be pregnant and if of child bearing age using adequate contraception
- Breast feeding
- Serious psychiatric comorbidity
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, LS9 7TF
Andrew Scarsbrook, 01132068212, andrew.scarsbrook@leedsth.nhs.uk
About this study
Official title: Evaluation of 4D-contrast Enhanced PET-CT in Tumour Volume Definition for Patients With Lung, Lower Oesophageal and Pancreatic Carcinomas.
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.
Read more
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.
- Being tested
- 4D PET-CT Scan, No intervention
- Medical subject headings
- Lung Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4D PET-CT ScanProcedure or surgery
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Routine CT scan plus 4D PET-CT scan | Other | Not described Receives: Procedure: 4D PET-CT Scan |
| Routine CT scan | Other | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2014 (estimated)
- Study startJun 2011
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- The Leeds Teaching Hospitals Charitable Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02285660
- Sponsor's protocol ID
- RD11/9711
- Other IDs
- 11/YH/0213
- Status last verified
- Nov 2014
- First submitted
- 21 Oct 2014
- Last updated
- 7 Nov 2014
- Results posted
- No
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.
PubMed 28978306
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of 4D-contrast Enhanced PET-CT in Tumour Volume Definition for Patients With Lung, Lower Oesophageal and Pancreatic Carcinomas.
- ClinicalTrials.gov ID
- NCT02285660
- Acronym / sponsor ID
- RD11/9711
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- The Leeds Teaching Hospitals Charitable Foundation
- Study start
- Jun 2011
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 7 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine CT scan plus 4D PET-CT scan | Other | Procedure: 4D PET-CT Scan |
| Routine CT scan | Other | Other: No intervention |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4D PET-CT Scan | Procedure or surgery | Routine CT scan plus 4D PET-CT scan |
| No intervention | Other | Routine CT scan |
Primary outcome
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)
Time frame: Up to two hours
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2014.
- Derived from this study: PubMed 28978306Scarsbrook 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4D PET-CT Scan in people with Lung Carcinoma and Lower Oesophageal Carcinoma, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew Scarsbrook (01132068212, andrew.scarsbrook@leedsth.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: Up to two hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02285660, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2014.