Lung NeoplasmNCT03516500
Trial of Identifying the Lung Intersegmental Plane by Iron Sucrose Injection Staining
A study testing Iron Sucrose Injection in people with Lung Neoplasm and Segmentectomy;Intersegmental Plane, run by Ruijin Hospital at 1 site in China.
Trial summary
This is a protocol to determine the safety and feasibility of using Iron Sucrose Injection to identify the intersegmental plane,not only on the pleural surface but also the parenchyma of the lung. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Neoplasm, Segmentectomy;Intersegmental Plane
- What is being tested?
- Iron Sucrose Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 9 May 2018to 21 Jan 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years ≤age ≤80 years
- The patient must be scheduled to undergo segmentectomy or combined subsegmentectomy.
- The patient must be willing and able to comply with all study requirements and have understood and signed the informed consent.
Who cannot join
- A known allergy to Iron Sucrose Injection
- The patients who have Iron overdose or iron utilization barrier Intra-operative founding of extensive pigmentation Silicosis or extensive carbon deposition in the lung.
- Patients who have not received segmental resection.
- Patients who converted to thoracotomy.
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, 200025
About this study
Official title: This is a Phase II Study on the Safety and Feasibility of Identifying the Intersegmental Plane of the Lung by Iron Sucrose Injection Staining,Both on the Pleural Surface and Lung Parenchyma
This is a protocol to determine the safety and feasibility of using Iron Sucrose Injection to identify the intersegmental plane,not only on the pleural surface but also the parenchyma of the lung.
Read the detailed description
This is a protocol to determine the safety and feasibility of using Iron Sucrose Injection to identify the lung intersegmental plane. This is relevant because the detection of small and early lung cancer is becoming increasingly common. segmentectomy may become a more prominent procedure for early-small lung cancer. One of the most difficult aspects of complete segmentectomy is detection of the intersegmental plane while maintaining an adequate surgical margin and remaining lung function. The method used to detect the intersegmental plane remains controversial. It is hoped that this technology can be used to recognize the intersegmental plane on the pleural surface and the pulmonary parenchyma and will save lots of money for patients in developing countries.
- Conditions
- Lung Neoplasm, Segmentectomy;Intersegmental Plane
- Being tested
- Iron Sucrose Injection
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron Sucrose InjectionDrug
The investigators inject Iron Sucrose (100 mg dissolved in 50 mL saline) into the segmental bronchus.
| Study group | Role | What they receive |
|---|---|---|
| Iron Sucrose injection group | Experimental | The investigators inject Iron Sucrose (100 mg dissolved in 50 mL saline) through a butterfly needle into the bronchus of the targeting segment. Receives: Drug: Iron Sucrose Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-related grade 3-5 adverse events
Incidence of treatment-related grade 3-5 adverse events assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0
Measured: Up to 90 days post-surgery
Secondary outcomes (1)
Surgical margin
Intraoperative measured by the surgeons.From the tumor peripheral to the lung margin.According to the guidelines,the margins should ≥2cm or ≥ the size of the tumor.
Measured: Day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start9 May 2018
- Primary completion21 Jan 2021
- Study completion21 Jan 2021
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 Lung NeoplasmStudies of the same condition, open and under way.
- More trials run by Ruijin 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- After the investigators cut the pulmonary vessels and ligate the segmental bronchus. The investigators inject Iron Sucrose (100 mg dissolved in 50 mL saline) through a butterfly needle into the bronchus of the targeting segment.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hecheng Li M.D., Ph.D, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03516500
- Sponsor's protocol ID
- RTS-006
- Status last verified
- Aug 2021
- First submitted
- 30 Mar 2018
- Last updated
- 31 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Li C, Zhang X, Feng X, Han D, Xiang J, Li H. A feasible technique for distinguishing the intersegmental plane by transbronchial injection of iron sucrose. JTCVS Tech. 2023 Jan 16;18:137-142. doi: 10.1016/j.xjtc.2022.12.007. eCollection 2023 Apr.
PubMed 37096093
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- This is a Phase II Study on the Safety and Feasibility of Identifying the Intersegmental Plane of the Lung by Iron Sucrose Injection Staining,Both on the Pleural Surface and Lung Parenchyma
- ClinicalTrials.gov ID
- NCT03516500
- Acronym / sponsor ID
- RTS-006
- Conditions
- Lung Neoplasm, Segmentectomy;Intersegmental Plane
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 9 May 2018 (actual)
- Primary completion
- 21 Jan 2021 (actual)
- Study completion
- 21 Jan 2021 (actual)
- First posted
- 4 May 2018 (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.
This is a protocol to determine the safety and feasibility of using Iron Sucrose Injection to identify the intersegmental plane,not only on the pleural surface but also the parenchyma of the lung.
Detailed description
This is a protocol to determine the safety and feasibility of using Iron Sucrose Injection to identify the lung intersegmental plane. This is relevant because the detection of small and early lung cancer is becoming increasingly common. segmentectomy may become a more prominent procedure for early-small lung cancer. One of the most difficult aspects of complete segmentectomy is detection of the intersegmental plane while maintaining an adequate surgical margin and remaining lung function. The method used to detect the intersegmental plane remains controversial. It is hoped that this technology can be used to recognize the intersegmental plane on the pleural surface and the pulmonary parenchyma and will save lots of money for patients in developing countries.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- After the investigators cut the pulmonary vessels and ligate the segmental bronchus. The investigators inject Iron Sucrose (100 mg dissolved in 50 mL saline) through a butterfly needle into the bronchus of the targeting segment.
| Arm | Type | Receives |
|---|---|---|
| Iron Sucrose injection group | Experimental | Drug: Iron Sucrose InjectionThe investigators inject Iron Sucrose (100 mg dissolved in 50 mL saline) through a butterfly needle into the bronchus of the targeting segment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years ≤age ≤80 years
- The patient must be scheduled to undergo segmentectomy or combined subsegmentectomy.
- The patient must be willing and able to comply with all study requirements and have understood and signed the informed consent.
Key exclusion criteria (4 listed)
- A known allergy to Iron Sucrose Injection
- The patients who have Iron overdose or iron utilization barrier Intra-operative founding of extensive pigmentation Silicosis or extensive carbon deposition in the lung.
- Patients who have not received segmental resection.
- Patients who converted to thoracotomy.
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 |
|---|---|---|
| Iron Sucrose InjectionThe investigators inject Iron Sucrose (100 mg dissolved in 50 mL saline) into the segmental bronchus. | Drug | Iron Sucrose injection group |
Primary outcome
Incidence of treatment-related grade 3-5 adverse events
Time frame: Up to 90 days post-surgery
Incidence of treatment-related grade 3-5 adverse events assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0
1 secondary outcome
Surgical margin
Time frame: Day of surgery
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 31 Aug 2021.
- Derived from this study: PubMed 37096093Li C, Zhang X, Feng X, Han D, Xiang J, Li H. A feasible technique for distinguishing the intersegmental plane by transbronchial injection of iron sucrose. JTCVS Tech. 2023 Jan 16;18:137-142. doi: 10.1016/j.xjtc.2022.12.007. eCollection 2023 Apr.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iron Sucrose Injection in people with Lung Neoplasm and Segmentectomy;Intersegmental Plane, run by Ruijin 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 3 inclusion and 4 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 31 Aug 2021. 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?
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?
Incidence of treatment-related grade 3-5 adverse events (time frame: Up to 90 days post-surgery). 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 NCT03516500, 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 31 Aug 2021.