Lung Cancer
Conditions
Keywords
lung nodule, lung cancer, lung mass
Brief summary
This is a phase II protocol to determine the safety and feasibility of Intraoperative CT fluoroscopy guidance for lung resection for small nodules.
Detailed description
This is a phase II protocol to determine the safety and feasibility of image guided CT marking for resection of small lung nodules. This is relevant because many such nodules are hard to localize for minimally invasive lung resection. It is hoped that this technology using fluoro CT capability available now in most operating room will improve safety and reliability of thoracic surgery.
Interventions
PROCEDUREVideo-Assisted Thoracic Surgery (VATS) wedge resection
Sponsors
Siemens Medical Solutions USA - CSG
Brigham and Women's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* peripheral lung nodules \< 3cm in size * Surgical candidate
Exclusion criteria
* Non surgical candidate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | 30 days | The patient will be monitored while in the hospital by their thoracic surgical team as well as by two research nurses named Lauren Donahue, RN and Karen Magsipoc, NP. The research nurses will document any perioperative complications and mortality that arise during the patient's stay in the hospital. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients Underwent a Successful Resection | 30 days | Number of patients who underwent a successful resection which is measured by an accurate and appropriate resection in a given timeline |
Countries
United States
Participant flow
Recruitment details
The recruitment for this study was completed in the medical clinic and started in April 2013 and included in September 2014.
Participants by arm
| Arm | Count |
|---|---|
| CT Marking and VATS Lung Wedge Resection Each patient with a lung nodule meeting criteria will undergo marking with fiducials followed at the same time by Video-Assisted Thoracic Surgery (VATS) lung wedge resection under CT fluoroscopy.
Video-Assisted Thoracic Surgery (VATS) wedge resection | 23 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | No lung nodule found on intraop CT scan | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | CT Marking and VATS Lung Wedge Resection | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 11 Participants | — |
| Age, Categorical Between 18 and 65 years | 12 Participants | — |
| Age, Continuous | 65 Years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 23 Participants | — |
| Sex: Female, Male Female | 16 Participants | — |
| Sex: Female, Male Male | 7 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 23 |
| other Total, other adverse events | 1 / 23 |
| serious Total, serious adverse events | 0 / 23 |
Outcome results
Primary
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
The patient will be monitored while in the hospital by their thoracic surgical team as well as by two research nurses named Lauren Donahue, RN and Karen Magsipoc, NP. The research nurses will document any perioperative complications and mortality that arise during the patient's stay in the hospital.
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CT Marking and VATS Lung Wedge Resection | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | 1 Participants |
Secondary
Patients Underwent a Successful Resection
Number of patients who underwent a successful resection which is measured by an accurate and appropriate resection in a given timeline
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CT Marking and VATS Lung Wedge Resection | Patients Underwent a Successful Resection | 23 Participants |