Lung CancerNCT03403127
PET CT Re-Planning NSCLC (4DCT-PET)
A study testing PET/CT Scans in people with Lung Cancer and Non-Small Cell Lung Cancer, run by University Health Network, Toronto.
Trial summary
This study will see whether the addition of more frequent planning CTs during the course of radiation, and of Positron Emission Tomography (PET), a diagnostic test similar to CT, prior to and during a course of radiation may provide information that could potentially be used during the treatment to improve the initial… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Non-Small Cell Lung Cancer
- What is being tested?
- PET/CT Scans
- Type of treatment
- Injection or infusion
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2008to 28 Apr 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age equal to or more than 18 years old
- Patients with NSCLC consenting for radiotherapy to the primary tumor and / or mediastinal / hilar lymph nodes. Prescription doses should be 60Gy or higher.
- Chemo-RT patients of any stage of NSCLC
- Patients with a measurable tumor on CT scan.
- Patients who are able to lie supine for two consecutive 25 minutes sessions.
Who cannot join
- Trimodality patients who will have surgery within 2 months post RT
- Previous radiotherapy to intended treatment volumes.
- Patients with recurrent disease
- Active malignancy other than lung cancer
- Pregnancy
- Failure to provide written informed consent
About this study
Official title: Prospective Study of CT and PET Imaging During a Course of Radical Radiotherapy to Determine the Dosimetric Benefits of Re-Planning in Non-Small Cell Lung Cancer
This study will see whether the addition of more frequent planning CTs during the course of radiation, and of Positron Emission Tomography (PET), a diagnostic test similar to CT, prior to and during a course of radiation may provide information that could potentially be used during the treatment to improve the initial radiation plan.
- Conditions
- Lung Cancer, Non-Small Cell Lung Cancer
- Being tested
- PET/CT Scans
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CT ScansDiagnostic test
PET Imaging requires the use of an investigational drug, a radioactively-labelled sugar called 18F-Fluorodeoxyglucose (FDG). FDG is glucose labelled with a radioactive fluorine atom. It is given by intravenous injection and is particularly absorbed by cancer cells. The radioactive signal given off by the FDG can then be detected by the PET scanner providing an image of the cancer (or tumour).
What is being measured
The primary outcome is the main question the study is designed to answer.
GTV volumes
The ratio of the GTV volumes defined using 4D CT (GTV4DCT) planning scans is a prognostic parameter for NSCLC.
Measured: 2 weeks post RT treatment
GTV volumes
The ratio of the GTV volumes defined using 4D CT (GTV4DCT) planning scans is a prognostic parameter for NSCLC
Measured: 4 weeks post RT Treatment
GTV volumes
The ratio of the GTV volumes defined using 4D CT (GTV4DCT) planning scans is a prognostic parameter for NSCLC
Measured: 7 weeks post RT Treatment
GTV volumes
he ratio of the GTV volumes defined using 4D CT (GTV4DCT) planning scans is a prognostic parameter for NSCLC
Measured: 3 months post RT treatment
GTV volumes
The ratio of the GTV volumes defined using FDG PET (GTVPET) planning scans
Measured: 2 weeks post RT Treatment
GTV Volumes
The ratio of the GTV volumes defined using FDG PET (GTVPET) planning scans
Measured: 4 weeks post RT Treatment
GTV Volumes
The ratio of the GTV volumes defined using FDG PET (GTVPET) planning scans
Measured: 7 weeks post RT Treatment
GTV volumes
The ratio of the GTV volumes defined using FDG PET (GTVPET) planning scans
Measured: 3 months post RT treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start20 May 2008
- Primary completion25 Mar 2013
- Study completion28 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03403127
- Sponsor's protocol ID
- 08-0269
- Status last verified
- Aug 2020
- First submitted
- 11 Jan 2018
- Last updated
- 14 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of CT and PET Imaging During a Course of Radical Radiotherapy to Determine the Dosimetric Benefits of Re-Planning in Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03403127
- Acronym / sponsor ID
- 08-0269
- Conditions
- Lung Cancer, Non-Small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 20 May 2008 (actual)
- Primary completion
- 25 Mar 2013 (actual)
- Study completion
- 28 Apr 2020 (actual)
- First posted
- 18 Jan 2018 (actual)
- 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.
This study will see whether the addition of more frequent planning CTs during the course of radiation, and of Positron Emission Tomography (PET), a diagnostic test similar to CT, prior to and during a course of radiation may provide information that could potentially be used during the treatment to improve the initial radiation plan.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age equal to or more than 18 years old
- Patients with NSCLC consenting for radiotherapy to the primary tumor and / or mediastinal / hilar lymph nodes. Prescription doses should be 60Gy or higher.
- Chemo-RT patients of any stage of NSCLC
- Patients with a measurable tumor on CT scan.
- Patients who are able to lie supine for two consecutive 25 minutes sessions.
Key exclusion criteria (6 listed)
- Trimodality patients who will have surgery within 2 months post RT
- Previous radiotherapy to intended treatment volumes.
- Patients with recurrent disease
- Active malignancy other than lung cancer
- Pregnancy
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 |
|---|---|---|
| PET/CT ScansPET Imaging requires the use of an investigational drug, a radioactively-labelled sugar called 18F-Fluorodeoxyglucose (FDG). FDG is glucose labelled with a radioactive fluorine atom. It is given by intravenous injection and is particularly absorbed by cancer cells. The radioactive signal given off by the FDG can then be detected by the PET scanner providing an image of the cancer (or tumour). | Diagnostic test | – |
Primary outcome
GTV volumes
Time frame: 2 weeks post RT treatment
The ratio of the GTV volumes defined using 4D CT (GTV4DCT) planning scans is a prognostic parameter for NSCLC.
GTV volumes
Time frame: 4 weeks post RT Treatment
The ratio of the GTV volumes defined using 4D CT (GTV4DCT) planning scans is a prognostic parameter for NSCLC
GTV volumes
Time frame: 7 weeks post RT Treatment
The ratio of the GTV volumes defined using 4D CT (GTV4DCT) planning scans is a prognostic parameter for NSCLC
GTV volumes
Time frame: 3 months post RT treatment
he ratio of the GTV volumes defined using 4D CT (GTV4DCT) planning scans is a prognostic parameter for NSCLC
GTV volumes
Time frame: 2 weeks post RT Treatment
The ratio of the GTV volumes defined using FDG PET (GTVPET) planning scans
GTV Volumes
Time frame: 4 weeks post RT Treatment
The ratio of the GTV volumes defined using FDG PET (GTVPET) planning scans
GTV Volumes
Time frame: 7 weeks post RT Treatment
The ratio of the GTV volumes defined using FDG PET (GTVPET) planning scans
GTV volumes
Time frame: 3 months post RT treatment
The ratio of the GTV volumes defined using FDG PET (GTVPET) planning scans
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing PET/CT Scans in people with Lung Cancer and Non-Small Cell Lung Cancer, run by University Health Network, Toronto.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 14 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GTV volumes (time frame: 2 weeks post RT treatment). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2020.