Non-small Cell Lung CancerNCT03053804
Clinical Application of MR-PET in Non-small Cell Lung Cancer: Diagnosis, Treatment Outcome, and Prognosis Prediction
A study testing MR/PET in people with Non-small Cell Lung Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
It is a study that hypothesize that MR/PET can have better information than current CT image study, about the medical or surgical treatment outcome of lung cancer Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- MR/PET
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2015to Dec 2018
- 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 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: > 20 years old.
- Patients have confirmed lung cancer by histopathological methods (fiber, bronchoscopy, lung biopsy, open chest biopsy, pleural effusion exfoliated cells, sputum exfoliated cells)
- Patients voluntarily to join this study and signed informed consents.
Who cannot join
- Any body metal implants (pacemaker implantation, nerve stimulator, vascular stent, aneurysm clip, eye foreign body, the inner metal prosthesis) or artificial heart valves
- Patients with claustrophobia to MRI examination
- Patients who are reluctant to comply with follow-up and subsequent examination
- The other condition that do not meet the inclusion criteria.
- Pregnancy.
- Age < 20 years old.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taipei, 100
Yeun-Chung Chang, MD, 02-23123456*65566, ycc5566@ntu.edu.tw
About this study
Official title: Clinical Application of MR-PET in Non-small Cell Lung Cancer: Diagnosis, Treatment, Outcome, and Prognosis Prediction
It is a study that hypothesize that MR/PET can have better information than current CT image study, about the medical or surgical treatment outcome of lung cancer
Read the detailed description
The investigators analyze tumor size、ADCmean、ADCmin、DCE、SUVmax、SUVmin、etc in MR/PET study，to compare its efficacy with other image studies in tumor malignancy grade, systemic involvement detection, treatment outcome after medical target therapy and treatment outcome after surgery.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- MR/PET
- Keywords
- MR/PET, Non-small cell lung cancer (NSCLC)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR/PETRadiation
MR/PET with contrast media and FDG-18
| Study group | Role | What they receive |
|---|---|---|
| MR/PET | Experimental | hypothesize that MR/PET can have better information than current CT image study Receives: Radiation: MR/PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline PET/MR parameters at 2 months after treatment
Measured: 2 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study startMar 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital, Yun-Lin Branch
- Responsible party
- Sponsor
- Investigators
- Yeun-Chung Chang, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03053804
- Sponsor's protocol ID
- 201501073RINA
- Status last verified
- Nov 2016
- First submitted
- 30 Oct 2016
- Last updated
- 15 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of MR-PET in Non-small Cell Lung Cancer: Diagnosis, Treatment, Outcome, and Prognosis Prediction
- ClinicalTrials.gov ID
- NCT03053804
- Acronym / sponsor ID
- 201501073RINA
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- MR/PET, Non-small cell lung cancer (NSCLC)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital, Yun-Lin Branch
- Study start
- Mar 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 15 Feb 2017 (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.
It is a study that hypothesize that MR/PET can have better information than current CT image study, about the medical or surgical treatment outcome of lung cancer
Detailed description
The investigators analyze tumor size、ADCmean、ADCmin、DCE、SUVmax、SUVmin、etc in MR/PET study，to compare its efficacy with other image studies in tumor malignancy grade, systemic involvement detection, treatment outcome after medical target therapy and treatment outcome after surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MR/PET | Experimental | Radiation: MR/PEThypothesize that MR/PET can have better information than current CT image study |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: > 20 years old.
- Patients have confirmed lung cancer by histopathological methods (fiber, bronchoscopy, lung biopsy, open chest biopsy, pleural effusion exfoliated cells, sputum exfoliated cells)
- Patients voluntarily to join this study and signed informed consents.
Key exclusion criteria (6 listed)
- Any body metal implants (pacemaker implantation, nerve stimulator, vascular stent, aneurysm clip, eye foreign body, the inner metal prosthesis) or artificial heart valves
- Patients with claustrophobia to MRI examination
- Patients who are reluctant to comply with follow-up and subsequent examination
- The other condition that do not meet the inclusion criteria.
- 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 |
|---|---|---|
| MR/PETMR/PET with contrast media and FDG-18 | Radiation | MR/PET |
Primary outcome
Change from Baseline PET/MR parameters at 2 months after treatment
Time frame: 2 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
- Individual participant dataSharing planned: No
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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.
Yeun-Chung Chang, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MR/PET in people with Non-small Cell Lung Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 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: status not confirmed, as of the sponsor's last update on 15 Feb 2017. 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 Taiwan. 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 Yeun-Chung Chang (02-23123456*65566, ycc5566@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline PET/MR parameters at 2 months after treatment (time frame: 2 months after treatment). 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 15 Feb 2017.