Focal pulmonary lesions MedDRA version: 20.0 Level: PT Classification code 10077488 Term: Pulmonary resection System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Patent Blue V Sodium Injection 2,5 % (25 mg/ml)
Product Name: Patent Blue V Sodium Injection 2,5 %
Pharmaceutical Form: Solution for injection
INN or Proposed INN: SODIUM PATENT BLUE V
CAS
Sponsors
Fakultní nemocnice u sv. Anny v Brne
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 years 2. Subpleurally deposited pulmonary lesion(s) with the need for further histological diagnosis, which is/are: 2.1. located at a depth of 0 30 mm below the pleura 2.2. less than 40 mm 2.3. with growth progression according to Lung -RADS criteria (version 1.1) 2.4. clearly not infiltrating the parietal pleura according to CT examination 3. Cognitive fitness and medical condition of the patient enabling a full understanding of information about clinical trial and signing of informed consent 4. Participants in a clinical trial of childbearing potential must agree to the use of prescribed contraceptive methods for the duration of the following clinical trial: 4.1. Women - Proper use of a highly reliable method of contraception, ie combined hormonal contraceptives (in oral, vaginal, or transdermal dosage form), gestagen hormonal contraceptives associated with ovulation inhibition (in oral or injectable dosage form), non-hormonal intrauterine device, or hormone-releasing intrauterine device, ev. the presence of bilateral tubal occlusion, a partner's vasectomy, or adherence to sexual abstinence. 4.2. Men - Adherence to sexual abstinence or the use of an adequate contraceptive method (ie condom) in case of sexual intercourse. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 72 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnancy or breast-feeding 2. History of hypersensitivity/allergy to patent blue or triphenylmethane dyes in medicinal products, food or cosmetics 3. Hypersensitivity/allergy or history of severe adverse reactions to iodine or iodine contrast agents (eg severe renal impairment following prior administration of an iodine contrast agent) 4. Hypersensitivity/allergy to excipients in investigated medical product 5. Hypersensitivity/allergy to trimecaine, or other local anesthetics 6. Manifest hyperthyroidism or thyrotoxicosis 7. Scheduled thyroid scan, thyroid function test, or radioiodine treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Proof of the advantage of subpleural lung nodules marking.;Secondary Objective: 1. Detailed characteristic of nodules 2. Marking method feasibility 3. Additional safety information ;Primary end point(s): 1. Success of the performed marking under CT control and simultaneous visualization of the marked area by the surgeon 2. Intensity, severity, and frequency (incidence) of adverse events and reactions according to established AESIs 3. Evaluation of postoperative pain using VAS (Visual Analogue Scale for Pain Assessment) 4. Occurrence of intraoperative complications (yes/no, if yes: description of complication, duration, treatment) 5. Occurrence of postoperative pulmonary and cardiovascular complications (yes/no, if yes: description of complication, duration, treatment) 6. Consumption of analgesics;Timepoint(s) of evaluation of this end point: 1. Day 1 2. Day 1, Day 2, Day 3, Day 10, Day 30 3. Day 1, Day 2, Day 3, Day 10, (Day 30) 4. Day 1 5. Day 30 6. Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Detailed characteristic of nodules 1.1. Typification of the nodule according to Lung-RADS and subsequent correlation with the pathological finding after resection 1.2. Percentage evaluation of benign and malignant etiology of deposits 1.3. Location of the nodule in the lung parenchyma (designation of the lung segment), its size (volume in cm3), and subpleural depth of the nodule (in mm from the parietal pleura) 2. Marking method feasibility 2.1. Total radiologist's time since arrival at CT (minutes) 2.2. Total time from the end of radiologist marking to the visualization of the lesion by the surgeon (minutes) 2.3. Presence of coloring substance outside the marked area (parietal pleura, mediastinum, free thoracic cavity) - evaluated by the surgeon perioperatively (YES / NO) 2.3. Comparison of the volume of the marked area after resection with the size of the solid deposit on CT (the pathologist supplies 3 dimensions of the resection to calculate its volume (a x b x c) in cm3, the radiologist calculates the volume of the solid deposit according to the dimensions from CT) 3. Additional safety information 3.1. Evaluation of postoperative X-ray findings 2 hours after surgery, at the time of reduction of chest suction to 8 cm of the water column, 2 hours after chest drain extraction, and at the time of suture extraction during outpatient control (7th - 14th postoperative day) 3.2. Total chest drain time (days) 3.3. Length of hospitalization 3.4. Length of stay in the ICU 3.5. Postoperative quality of life according to the SF-36 questionnaire 3.6. 30-day mortality ;Timepoint(s) of evaluation of this end point: 1. Detailed characteristic of nodules 1.1. Day 1 1.2. Day 10 1.3. Day 1 2. Marking method feasibility 2.1. Day 1 2.2. Day 1 2.3. Day 1 3. Additional safety information 3.1. Day 1, (Day 2, Day 3, Day 10) 3.2. Day 30 3.3. Day 30 3.4. Day 30 3.5. Day 0, Day 30 3.6. Day 30 | — |
Countries
Czech Republic
Contacts
Public ContactOddelení klinických studií
Fakultní nemocnice u sv. Anny v Brne
Outcome results
None listed