NCT05676788Not yet recruiting
HSI for Intersegmental Plane Identification During Sublobar Pulmonary Resections
Hyperspectral Imaging for Intersegmental Plane Identification During Sublobar Pulmonary Resections in Lung Cancer Patients
Source: ClinicalTrials.gov · Last updated 9 Jan 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The purpose of this study is the identification of the intersegmental plane and navigation during sublobar pulmonary resections in lung cancer using Hyperspectral Imaging, the comparison with ICG fluorescence intersegmental plane identification, and the establishment of automatic intersegmental plane navigation using machine learning strategies for intraoperative navigation.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 26 Nov 2022
- Start date
- Apr 2023
- Primary completion date
- May 2026
- Lead sponsor
- LungenClinic Grosshansdorf
- Diseases
- Lung cancer
- NCT number
- NCT05676788
What you commit to
- Study type: Interventional
- Planned participants: 50
- From Apr 2023 to the primary completion date, May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Requirement of a lobectomy or pneumonectomy to achieve complete resection
- Participation in any other interventional clinical trial within the last 30 days before the start of this trial
- Known or persistent abuse of medication, drugs or alcohol
Other illness
- Allergy to indocyanine green or iodine
- Medical condition which poses a high risk to undergo surgery as defined by the investigator
- Covid19 / SARS-CoV2-infection at time of screening
Other
- Hyperthyroidism
- Current or planned pregnancy, nursing period (if defined as requirement of clinical routine treatment)
- Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed
- Person who is in a relationship of dependence/employment with the coordinating investigator or the investigator
Who the study is looking for
- Histologically confirmed lung cancer stage I/II or malignancy suspicious nodules
- Segmentectomy is oncologically indicated or impaired pulmonary and/or cardiac function prevent anatomical resection
- Male or female patients aged ≥ 18 years without upper age limit
- Serum creatinine ≤ 1.5 x upper limit of normal or creatinine clearance (CrCl ≥ 50 mL/min, Cockcroft-Gault formula)
- Total bilirubin ≤ 1.5 x upper limit of normal (except patients with Gilbert Syndrome (Morbus Meulengracht) in whom total bilirubin \< 3.0 mg/dL is allowed)
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase)/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase) ≤ 2.5 x upper limit of normal
- Full legal capacity
- Written informed consent obtained according to international guidelines and local laws
- Ability to understand the nature of the trial and the trial related procedures and to comply with them
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| LungenClinic Großhansdorf Coordinator of this site? Confirm its status | Großhansdorf | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.