Thorax CancerDWIMRICSPLNCT02482181
Diffusion Weighted Magnetic Resonance Imaging for the Characterization of Solitary Pulmonary Lesions
An observational study of Thorax Cancer, run by ÇAĞLAYAN ÇAKIR at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study, is to investigate the value of diffusion weighted imaging on the differential diagnosis of solitary pulmonary lesions. Read more about this study
- Who is it for?
- Ages 20 to 78 yearsHealthy volunteers can take part
- Conditions the study is for
- Thorax Cancer
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2011to Dec 2011
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 78 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Magnetic resonance imaging (MRI) was applied to a total of 46 patients between January 2011 and July 2011, who presented.
Who may be able to join
- All patients had a solitary pulmonary nodule or mass.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study, is to investigate the value of diffusion weighted imaging on the differential diagnosis of solitary pulmonary lesions.
Read the detailed description
When a patient is diagnosed with a lung lesion, the differential diagnosis is important, since the treatment is determined by the lesion character. The goal in the evaluation of solitary pulmonary lesions is to distinguish malignant lesions from benign lesions in as non-invasive a manner as possible. As computed tomography is widely used, the diagnosis of solitary pulmonary lesions has become easier. The size, features of the edges, shape, internal structure (calcification, fat content, cavitation, etc.), density, satellite nodule, growth rate and contrast involvement of the lesion are important properties which help to distinguish benign lesions from malignant ones. However, as the distinction is not absolute at all times, other imaging methods such as positron emission tomography and magnetic resonance are preferred. The importance of this issue is the high five-year survival rate in early-diagnosed lung cancer cases.
Diffusion is the randomized microscopic motion of water molecules. It is known that diffusion is a sensitive parameter of tissue characterization at a microscopic level. Nowadays, diffusion is measured in vivo with diffusion weighted MRI and ADC measurements.
Diffusion weighted imaging has a wide use on oncologic patients for the purpose of diagnosis. In addition, it is used in the distinction of acute cerebral infarction and epidermoid or arachnoid cysts. Recently, it has also been used in the characterization of cystic or solid lesions in the thoracic cavity. In this study, the investigators aimed to evaluate the accuracy of differentiation of solitary pulmonary lesions.
- Conditions
- Thorax Cancer
- Keywords
- diffusion weighted magnetic resonance imaging
What is being measured
The primary outcome is the main question the study is designed to answer.
On diffusion weighted images, the signal intensities of the lesions were visually compared to the SI of the thoracic spinal cord using a 5-point scale.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study startJan 2011
- Primary completionDec 2011
- Study completionDec 2011
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 Thorax CancerStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- ÇAĞLAYAN ÇAKIR
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ÇAĞLAYAN ÇAKIR, Trakya University
- Investigators
- HAKAN GENÇHELLAÇ, MD, Study director, TURKEY,EDİRNE ,TRAKYA UNİVERSİTY HOSPİTAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02482181
- Sponsor's protocol ID
- TRAKYA22
- Acronym
- DWIMRICSPL
- Status last verified
- Jun 2015
- First submitted
- 19 Jun 2015
- Last updated
- 26 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Cakir C, Genchellac H, Temizoz O, Polat A, Sengul E, Duygulu G. Diffusion Weighted Magnetic Resonance Imaging for the Characterization of Solitary Pulmonary Lesions. Balkan Med J. 2015 Oct;32(4):403-9. doi: 10.5152/balkanmedj.2015.15663. Epub 2015 Oct 1.
PubMed 26740901
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diffusion Weighted Magnetic Resonance Imaging for the Characterization of Solitary Pulmonary Lesions
- ClinicalTrials.gov ID
- NCT02482181
- Acronym / sponsor ID
- DWIMRICSPL / TRAKYA22
- Conditions
- Thorax Cancer
- Keywords
- diffusion weighted magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- ÇAĞLAYAN ÇAKIRUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 26 Jun 2015 (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 purpose of this study, is to investigate the value of diffusion weighted imaging on the differential diagnosis of solitary pulmonary lesions.
Detailed description
When a patient is diagnosed with a lung lesion, the differential diagnosis is important, since the treatment is determined by the lesion character. The goal in the evaluation of solitary pulmonary lesions is to distinguish malignant lesions from benign lesions in as non-invasive a manner as possible. As computed tomography is widely used, the diagnosis of solitary pulmonary lesions has become easier. The size, features of the edges, shape, internal structure (calcification, fat content, cavitation, etc.), density, satellite nodule, growth rate and contrast involvement of the lesion are important properties which help to distinguish benign lesions from malignant ones. However, as the distinction is not absolute at all times, other imaging methods such as positron emission tomography and magnetic resonance are preferred. The importance of this issue is the high five-year survival rate in early-diagnosed lung cancer cases.
Diffusion is the randomized microscopic motion of water molecules. It is known that diffusion is a sensitive parameter of tissue characterization at a microscopic level. Nowadays, diffusion is measured in vivo with diffusion weighted MRI and ADC measurements.
Diffusion weighted imaging has a wide use on oncologic patients for the purpose of diagnosis. In addition, it is used in the distinction of acute cerebral infarction and epidermoid or arachnoid cysts. Recently, it has also been used in the characterization of cystic or solid lesions in the thoracic cavity. In this study, the investigators aimed to evaluate the accuracy of differentiation of solitary pulmonary lesions.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 20 to 78 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Magnetic resonance imaging (MRI) was applied to a total of 46 patients between January 2011 and July 2011, who presented.
Key inclusion criteria (1 listed)
- All patients had a solitary pulmonary nodule or mass.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
On diffusion weighted images, the signal intensities of the lesions were visually compared to the SI of the thoracic spinal cord using a 5-point scale.
Time frame: 1 year
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 26 Jun 2015.
- Derived from this study: PubMed 26740901Cakir C, Genchellac H, Temizoz O, Polat A, Sengul E, Duygulu G. Diffusion Weighted Magnetic Resonance Imaging for the Characterization of Solitary Pulmonary Lesions. Balkan Med J. 2015 Oct;32(4):403-9. doi: 10.5152/balkanmedj.2015.15663. Epub 2015 Oct 1.
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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.
HAKAN GENÇHELLAÇ, MD study director
TURKEY,EDİRNE ,TRAKYA UNİVERSİTY HOSPİTAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thorax Cancer, run by ÇAĞLAYAN ÇAKIR at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 26 Jun 2015. 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 Turkey (Türkiye). 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?
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?
On diffusion weighted images, the signal intensities of the lesions were visually compared to the SI of the thoracic spinal cord using a 5-point scale. (time frame: 1 year). 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 NCT02482181, 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 26 Jun 2015.