Pulmonary Nodule, SolitaryNCT04165603
Fluorescence-navigated Thoracoscopy for Detection of Small Pulmonary Nodules
A study testing Preoperative Infusion of Indocyanine Green in people with Pulmonary Nodule, Solitary and Pulmonary Nodule, Multiple, run by Peking University People's Hospital at 1 site in China.
Trial summary
Fluorescence-navigated thoracoscopic imaging with indocyanine green (ICG) is a novel technique for detection of small pulmonary nodules other than traditional radiography or intraoperative palpation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Nodule, Solitary, Pulmonary Nodule, Multiple
- What is being tested?
- Preoperative Infusion of Indocyanine Green
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 1 siteChina
- Study dates
- 18 Dec 2018to Jun 2021
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Peripheral pulmonary solid nodules, with diameter 1-3 cm.
- Suitable for surgery and signed informed consent.
Who cannot join
- Liver dysfunction.
- Allergic to indocyanine green.
- Can't tolerate thoracoscopic surgery.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Feng Yang, MD, +8618612978269, yangfeng1007@sina.com
About this study
Fluorescence-navigated thoracoscopic imaging with indocyanine green (ICG) is a novel technique for detection of small pulmonary nodules other than traditional radiography or intraoperative palpation. As a non-targeted fluorescent contrast agent, ICG accumulates in tumors by the enhanced permeability and retention effect (EPR), making the lesions fluoresce under fluorescent imaging. However, the optimal dosage and injection time of ICG are still under exploration. Hence, we perform this study in humans made up of four groups to determine the optimal time and dose.
- Being tested
- Preoperative Infusion of Indocyanine Green
- Medical subject headings
- Solitary Pulmonary Nodule, Multiple Pulmonary Nodules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Infusion of Indocyanine GreenProcedure or surgery
preoperatively infuse indocyanine green through peripheral vein
| Study group | Role | What they receive |
|---|---|---|
| 5mg/kg of ICG, 24h before surgery | Active comparator | 5mg/kg of indocyanine green, intravenously injection 24 hours before surgery Receives: Procedure: Preoperative Infusion of Indocyanine Green |
| 1mg/kg of ICG, 24h before surgery | Experimental | 1mg/kg of indocyanine green, intravenously injection 24 hours before surgery Receives: Procedure: Preoperative Infusion of Indocyanine Green |
| 5mg/kg of ICG, 48h before surgery | Experimental | 5mg/kg of indocyanine green, intravenously injection 48 hours before surgery Receives: Procedure: Preoperative Infusion of Indocyanine Green |
| 1mg/kg of ICG, 48h before surgery | Experimental | 1mg/kg of indocyanine green, intravenously injection 48 hours before surgery Receives: Procedure: Preoperative Infusion of Indocyanine Green |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signal-to-background Ratio (SBR) of the Tumor and Normal Parenchyma
We use image analysis software ImageJ to evaluate the strength of luminosity in tumors and normal parenchyma using intraoperative images and calculate signal-to-background-ratios.
Measured: within 1 week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start18 Dec 2018
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Nodule, SolitaryStudies of the same condition, open and under way.
- More trials run by Peking University People's 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 352 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Wang, Peking University People's Hospital
- Investigators
- Wang Jun, MD, Study director, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04165603
- Sponsor's protocol ID
- 2018PHB144-01
- Status last verified
- Nov 2019
- First submitted
- 10 Nov 2019
- Last updated
- 18 Nov 2019
- 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 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluorescence-navigated Thoracoscopy for Detection of Small Pulmonary Nodules
- ClinicalTrials.gov ID
- NCT04165603
- Acronym / sponsor ID
- 2018PHB144-01
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 352 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 18 Dec 2018 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 18 Nov 2019 (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.
Fluorescence-navigated thoracoscopic imaging with indocyanine green (ICG) is a novel technique for detection of small pulmonary nodules other than traditional radiography or intraoperative palpation. As a non-targeted fluorescent contrast agent, ICG accumulates in tumors by the enhanced permeability and retention effect (EPR), making the lesions fluoresce under fluorescent imaging. However, the optimal dosage and injection time of ICG are still under exploration. Hence, we perform this study in humans made up of four groups to determine the optimal time and dose.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 5mg/kg of ICG, 24h before surgery | Active comparator | Procedure: Preoperative Infusion of Indocyanine Green5mg/kg of indocyanine green, intravenously injection 24 hours before surgery |
| 1mg/kg of ICG, 24h before surgery | Experimental | Procedure: Preoperative Infusion of Indocyanine Green1mg/kg of indocyanine green, intravenously injection 24 hours before surgery |
| 5mg/kg of ICG, 48h before surgery | Experimental | Procedure: Preoperative Infusion of Indocyanine Green5mg/kg of indocyanine green, intravenously injection 48 hours before surgery |
| 1mg/kg of ICG, 48h before surgery | Experimental | Procedure: Preoperative Infusion of Indocyanine Green1mg/kg of indocyanine green, intravenously injection 48 hours before surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Peripheral pulmonary solid nodules, with diameter 1-3 cm.
- Suitable for surgery and signed informed consent.
Key exclusion criteria (3 listed)
- Liver dysfunction.
- Allergic to indocyanine green.
- Can't tolerate thoracoscopic surgery.
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 |
|---|---|---|
| Preoperative Infusion of Indocyanine Greenpreoperatively infuse indocyanine green through peripheral vein | Procedure or surgery | 1mg/kg of ICG, 24h before surgery, 1mg/kg of ICG, 48h before surgery, 5mg/kg of ICG, 24h before surgery, 5mg/kg of ICG, 48h before surgery |
Primary outcome
Signal-to-background Ratio (SBR) of the Tumor and Normal Parenchyma
Time frame: within 1 week after surgery
We use image analysis software ImageJ to evaluate the strength of luminosity in tumors and normal parenchyma using intraoperative images and calculate signal-to-background-ratios.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
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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.
Wang Jun, MD study director
Peking University People's 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 Preoperative Infusion of Indocyanine Green in people with Pulmonary Nodule, Solitary and Pulmonary Nodule, Multiple, run by Peking University People's 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 2 inclusion and 3 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 18 Nov 2019. 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 Feng Yang, MD ((+86) 18612978269, yangfeng1007@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Signal-to-background Ratio (SBR) of the Tumor and Normal Parenchyma (time frame: within 1 week after surgery). 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 18 Nov 2019.