Adenocarcinoma of LungNCT06441357
Differentiating the Invasiveness of Lung Adenocarcinoma by Dual Energy CT Parameter
An observational study of Adenocarcinoma of Lung, run by Tang-Du Hospital at 1 site in China.
Trial summary
The core purpose of this study is to investigate whether the extracellular volume (ECV) fraction measured in delay phase by dual energy computed tomography (DECT) can distinguish precancerous lesions from early-stage lung adenocarcinomas, which could assist clinical decision making for surgery operation indication and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma of Lung
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 30 Jun 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pulmonary nodules who intend to have contrast enhanced CT in Tangdu hospital.
Who may be able to join
- patients older than 18 years old with pulmonary nodules (diameter≤3 cm).
- pathologically confirmed as lung adenocarcinoma.
- without history of other malignancies.
- accurate hematocrit within 1 week before contrast enhanced dual energy CT examination.
Who cannot join
- with a history of allergy to iodine contrast agents and other reasons who are unable to complete the examination.
- without histopathology of invasion stage, such as AAH, AIS, MIA and IAC.
- history of chemotherapy, radiotherapy, or other anti-tumor therapy before contrast enhanced dual energy CT.
- poor image quality.
- contrast enhanced dual energy CT scans ≥ 4 weeks before surgery.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tangdu Hospital
Xi'an, Shaanxi, 710038
Cui Guangbin, Professor, 18992898517, cgbtd@126.com
Jiang Nan, 18093701139, tdfs_jn@163.com
About this study
Official title: Differentiating the Invasiveness of Lung Adenocarcinoma by Dual Energy CT Using Extracellular Volume Measured in Delay Phase
The core purpose of this study is to investigate whether the extracellular volume (ECV) fraction measured in delay phase by dual energy computed tomography (DECT) can distinguish precancerous lesions from early-stage lung adenocarcinomas, which could assist clinical decision making for surgery operation indication and strategy.
Read the detailed description
Although progression of lung adenocarcinoma (LUAD) depends on driver mutations, it is also affected by tumor microenvironment (TME), including vessels, immune cells and extracellular matrix (ECM). As major constituent of TME, ECM mediates interactions between cancer cells and stromal cells, promotes angiogenesis, epithelial-mesenchymal transition, causes metastasis and resistance to immune therapy. Along with the progression of LUAD histologic stages, from atypical adenomatous hyperplasia (AAH) and adenocarcinoma in situ (AIS) to minimally invasive adenocarcinoma (MIA), and finally to invasive adenocarcinoma (IA), the composition of the ECM changes a lot, which has some characterizations same as interstitial pulmonary fibrosis. Hence, identifying the pathological ECM status may help differentiating the invasiveness of lung adenocarcinomas.
Based on the theory that in delay phase, the contrast medium is evenly distributed in the intravascular and extravascular-extracellular spaces and not entering the cell, extracellular volume (ECV) fraction is considered as a potential quantitative imaging parameter for ECM. It has been confirmed that ECV fraction is highly consistent with pathological fibrosis in cardiac and hepatic diseases. In other lesions with fibrosis such as pancreatic and thymic epithelial tumors, ECV fraction also has positive effects in malignancy prediction. It has been verified that ECV fraction is capable of differentiating lung cancer with benign lung lesions and classifying lung cancers into three subtypes. However, there has yet no study testified it as an invasion predictor.
The core purpose of this study is to investigate whether ECV fraction can distinguish precancerous lesions from early-stage lung adenocarcinomas and compare it with other confirmed radiological features in prediction performance, which is clinically meaningful regarding optimal treatment selection and avoidance of unnecessary surgical procedures.
- Conditions
- Adenocarcinoma of Lung
- Keywords
- ECV, invasion, lung adenocarcinoma, DECT
- Medical subject headings
- Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with preinvasive lung adenocarcinomas | preinvasive lung adenocarcinomas include atypical adenomatous hyperplasia (AAH), adenocarcinoma in situ (AIS) and minimally invasive adenocarcinoma (MIA) | |
| Patients with invasive lung adenocarcinomas | invasive adenocarcinoma(IAC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acquire DECT parameters in patients with pulmonary nodules.
Including iodine concentration (IC) in delay phase, normalized IC (NIC), effective atomic number (Zeff), and CT attenuation values of nodules from virtual monochromatic images (VMIs) (energy range from 40 to 150 keV, 10keV as interval).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start1 Jun 2024 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of LungStudies of the same condition, open and under way.
- More trials run by Tang-Du 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cui Guangbin, Study chair, ang-Du Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441357
- Sponsor's protocol ID
- TDFS20240328
- Status last verified
- May 2024
- First submitted
- 28 May 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differentiating the Invasiveness of Lung Adenocarcinoma by Dual Energy CT Using Extracellular Volume Measured in Delay Phase
- ClinicalTrials.gov ID
- NCT06441357
- Acronym / sponsor ID
- TDFS20240328
- Conditions
- Adenocarcinoma of Lung
- Keywords
- ECV, invasion, lung adenocarcinoma, DECT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 4 Jun 2024 (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.
The core purpose of this study is to investigate whether the extracellular volume (ECV) fraction measured in delay phase by dual energy computed tomography (DECT) can distinguish precancerous lesions from early-stage lung adenocarcinomas, which could assist clinical decision making for surgery operation indication and strategy.
Detailed description
Although progression of lung adenocarcinoma (LUAD) depends on driver mutations, it is also affected by tumor microenvironment (TME), including vessels, immune cells and extracellular matrix (ECM). As major constituent of TME, ECM mediates interactions between cancer cells and stromal cells, promotes angiogenesis, epithelial-mesenchymal transition, causes metastasis and resistance to immune therapy. Along with the progression of LUAD histologic stages, from atypical adenomatous hyperplasia (AAH) and adenocarcinoma in situ (AIS) to minimally invasive adenocarcinoma (MIA), and finally to invasive adenocarcinoma (IA), the composition of the ECM changes a lot, which has some characterizations same as interstitial pulmonary fibrosis. Hence, identifying the pathological ECM status may help differentiating the invasiveness of lung adenocarcinomas.
Based on the theory that in delay phase, the contrast medium is evenly distributed in the intravascular and extravascular-extracellular spaces and not entering the cell, extracellular volume (ECV) fraction is considered as a potential quantitative imaging parameter for ECM. It has been confirmed that ECV fraction is highly consistent with pathological fibrosis in cardiac and hepatic diseases. In other lesions with fibrosis such as pancreatic and thymic epithelial tumors, ECV fraction also has positive effects in malignancy prediction. It has been verified that ECV fraction is capable of differentiating lung cancer with benign lung lesions and classifying lung cancers into three subtypes. However, there has yet no study testified it as an invasion predictor.
The core purpose of this study is to investigate whether ECV fraction can distinguish precancerous lesions from early-stage lung adenocarcinomas and compare it with other confirmed radiological features in prediction performance, which is clinically meaningful regarding optimal treatment selection and avoidance of unnecessary surgical procedures.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with preinvasive lung adenocarcinomas | – | –preinvasive lung adenocarcinomas include atypical adenomatous hyperplasia (AAH), adenocarcinoma in situ (AIS) and minimally invasive adenocarcinoma (MIA) |
| Patients with invasive lung adenocarcinomas | – | –invasive adenocarcinoma(IAC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pulmonary nodules who intend to have contrast enhanced CT in Tangdu hospital.
Key inclusion criteria (4 listed)
- patients older than 18 years old with pulmonary nodules (diameter≤3 cm).
- pathologically confirmed as lung adenocarcinoma.
- without history of other malignancies.
- accurate hematocrit within 1 week before contrast enhanced dual energy CT examination.
Key exclusion criteria (5 listed)
- with a history of allergy to iodine contrast agents and other reasons who are unable to complete the examination.
- without histopathology of invasion stage, such as AAH, AIS, MIA and IAC.
- history of chemotherapy, radiotherapy, or other anti-tumor therapy before contrast enhanced dual energy CT.
- poor image quality.
- contrast enhanced dual energy CT scans ≥ 4 weeks before surgery.
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
Acquire DECT parameters in patients with pulmonary nodules.
Time frame: 2 years
Including iodine concentration (IC) in delay phase, normalized IC (NIC), effective atomic number (Zeff), and CT attenuation values of nodules from virtual monochromatic images (VMIs) (energy range from 40 to 150 keV, 10keV as interval).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
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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.
Cui Guangbin study chair
ang-Du Hospital
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 Adenocarcinoma of Lung, run by Tang-Du Hospital at 1 site in China.
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 4 inclusion and 5 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 4 Jun 2024. 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 China. 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 Cui Guangbin, Professor (18992898517, cgbtd@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acquire DECT parameters in patients with pulmonary nodules. (time frame: 2 years). 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 4 Jun 2024.