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Lung NeoplasmsNCT03357094

Pulmonary Ventilation/Perfusion Imaging for the Prediction of Postoperative Residual Pulmonary Function

An observational study of Lung Neoplasms, run by Beijing Tongren Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Lung cancer is one of the most common malignant tumors in the world and with the highest incidence in China. Surgery is the most effective therapeutic method for primary lung cancer. Read more about this study

Who is it for?
Ages 30 to 80 years
Conditions the study is for
Lung Neoplasms
How many people
50 participants
Where
1 siteChina
Study dates
30 Sep 2017to 1 Nov 2019
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 30 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Newly diagnosed and pre-therapeutic patients with primary lung cancer.

Inclusion criteria: age 30-80 years old; newly diagnosis of primary lung cancer with radiological or pathological evidence; SPECT/CT scan was performed before surgery; written and informed consent with signature before the study.

Exclusion criteria: with other tumor in addition to primary lung caner; receive surgery prior to SPECT/CT scan; failed to complete preoperative and postoperative pulmonary function tests; failed to perform scans; pregnancy, lactation, and impaired renal or liver function; poorly controlled diabetes; poor compliance; contrary to the standard operating procedures; not suitable for clinical trials (for example with mental illness);

Trial locations and contacts

1 site in 1 country.

wang shuang, master contact

010-58268056

wangs198801@126.com

China1 site, 1 recruiting

  • Tongren Hospital

    Beijing, Beijing Municipality

    Shuang Wang, MD, 010-58268056, wangs198801@126.com

    Recruiting

Other trials in China

About this study

Official title: Pulmonary Ventilation/Perfusion Imaging With SPECT/CT for the Prediction of Postoperative Residual Pulmonary Function in Patients With Primary Lung Cancer: A Multi-center Clinical Study

Lung cancer is one of the most common malignant tumors in the world and with the highest incidence in China. Surgery is the most effective therapeutic method for primary lung cancer. Accurate prediction of residual postoperative pulmonary function in patients, especially those with borderline pulmonary function, is crucial for proper qualification for surgery. According to the 3rd American College of Chest Physicians(ACCP) evidence-based clinical practice guideline (2013), both predictive postoperative (ppo) FEV1.0% and ppoDLCO% are greater than 60% predicted are required as a first standard of lobectomy for patients with primary lung cancer. And, according to the British Thoracic Society (BTS) guideline, patients with ppoFEV1.0% and ppoDLco% less than 40% have high a risk for surgery. Pulmonary ventilation / perfusion SPECT/CT has recently become available for prediction of lung function, and it can be used to forecast pulmonary function in consideration of the pulmonary circulation as well as effective residual lung function. Traditionally, prediction of postoperative lung function was based on planar method in anterior and posterior projections of lung scintigraphy. However, SPECT/CT enables measurement of ventilation / perfusion uptake in each lobe of the lungs in a three dimensional way, which may avoid underestimating ppoFEV1.0% and provide confidence in suggesting lobectomy or pneumonectomy.

This experiment is intended to explore the use of Q.lung, a volume-based software to semi-quantitatively calculate pulmonary ventilation/perfusion functional uptake and volume by SPECT/CT. We hope it can get a more accurate prediction of postoperative residual pulmonary function to provide better management for clinical surgery.

Read the detailed description
  1. Newly diagnosed and pre-therapeutic patients with primary lung cancer
  2. Study sample: the optimal study sample is expected to be >50 cases
  3. Inclusion criteria: age 30-80 years old; newly diagnosis of primary lung cancer with radiological or pathological evidence; SPECT/CT scan was performed before surgery; written and informed consent with signature before the study
  4. Exclusion criteria: with other tumor in addition to primary lung caner; receive surgery prior to SPECT/CT scan; failed to complete preoperative and postoperative pulmonary function tests; failed to perform scans; pregnancy, lactation, and impaired renal or liver function; poorly controlled diabetes; poor compliance; contrary to the standard operating procedures; not suitable for clinical trials (for example with mental illness);

Study protocol:

  1. Examination time
  2. Preoperative lung function test was performed within a month prior to surgery
  3. Preoperative pulmonary ventilation/perfusion SPECT/CT were performed within a month prior to surgery
  4. Postoperative pulmonary function test as well as follow-up were performed within three months after surgery 2. Pulmonary function test including but not limited to: forced expiratory volume in 1s(FEV1), diffusing capacity carbon monoxide(DLCO), forced vital capacity(FVC), maximal voluntary ventilation (MVV), peak expiratory flow(PEFR), vital capacity(VC), total lung capacity(TLC) 3. Pulmonary ventilation/perfusion SPECT/CT imaging: acquisition protocol according to EANM guidelines for ventilation/perfusion scintigraphy. Part 1. Using Technegas for ventilation imaging and 99mTc-MAA for perfusion imaging.
  5. Image analysis：
  6. Ventilation / perfusion SPECT/CT data were registered, processed and reconstructed in GE Xeleris Workstation, quantitative measurements were using Q.lung software.
  7. Results including ventilation / perfusion uptake and volume (in counts and mL and respective percentage) of each pulmonary lobar.
  8. Data analysis:
  9. Predicted postoperative FEV1 (as well as other pulmonary function values) were calculated according to the following formula: FEV1 fore-v = FEV1 pre × (1- Volume%); FEV1 fore-cv = FEV1 pre × (1- Counts%v); FEV1 fore-cp = FEV1 pre × (1- Counts%p). *fore-v represents predicted postoperative value using volume; fore-cv represents predicted postoperative value using ventilation uptake; fore-cp represents predicted postoperative value using perfusion uptake; pre represents preoperative pulmonary test value.
  10. A graphical method of the Bland-Altman plot was used to compare FEV1 (as well as other pulmonary function values) obtained from predictions and post-operative measurements (with certain systematic and random errors). Intervals of agreement were drawn as the mean difference between predicted and measured values plus and minus 1.96 times the standard deviation of the differences. Strength of linear relationship between predicted and measured FEV1 values was quantified by the Pearson correlation coefficients with significance based on t-statistics. P < 0.05 is statistically significant.
Conditions
Lung Neoplasms
Keywords
Pulmonary ventilation, Pulmonary perfusion, Single Photon Emission Computed Tomography
Medical subject headings
Lung Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. compare actual postoperative lung function values to predicted values using residual pulmonary lobar volume by SPECT/CT

    using pulmonary lobar volume to calculate predicted postoperative pulmonary test values and compare them with actual postoperative values.

    Measured: 1 month

  2. compare actual postoperative lung function values to predicted values using residual ventilation uptake by SPECT/CT

    using ventilation uptake (in counts) to calculate predicted postoperative pulmonary test values and compare them with actual postoperative values.

    Measured: 1 month

  3. compare actual postoperative lung function values to predicted values using residual perfusion uptake by SPECT/CT

    using perfusion uptake (in counts) to calculate predicted postoperative pulmonary test values and compare them with actual postoperative values.

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2017
  2. Study start30 Sep 2017
  3. Primary completion1 Nov 2018 (estimated)
  4. Study completion1 Nov 2019 (estimated)

Resources

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
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03357094
Sponsor's protocol ID
tr12345
Status last verified
Oct 2017
First submitted
23 Nov 2017
Last updated
29 Nov 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Neoplasms, run by Beijing Tongren 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?

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 29 Nov 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 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 wang shuang, master (010-58268056, wangs198801@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

compare actual postoperative lung function values to predicted values using residual pulmonary lobar volume by SPECT/CT (time frame: 1 month). The study lists 3 primary outcomes in all. 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 NCT03357094.

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 29 Nov 2017.

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