Bone Diseases, Bone Neoplasm, Musculoskeletal Disease, Neoplasms, Skull Base Neoplasms, Skull Neoplasms
Conditions
Brief summary
This study is being done to demonstrate the feasibility of using a nasal endoscope to perform intraoperative angiography of surgical field, with the goals to evaluate anatomical landmarks and tumor characteristics during skull base surgery and publish a technical note.
Interventions
DEVICEnear-infrared light nasal endoscope used with ICG
Using the near-infrared light nasal endoscope with ICG will identify anatomical landmarks and and tumor characteristics to provide a clear demonstration of the blood supply.
Sponsors
Ohio State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years and above * Patients undergoing an an EEA for cranial base pathology that will require any of the following will be eligible for the study: optic canal decompression, intradural tumor dissection, dissection of tumor around the internal carotid artery.
Exclusion criteria
* Less than 18 years of age * History of sulfa, iodide, or penicillin allergy * Previous anaphylactic reaction to ICG * Women currently pregnant or nursing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ICG Fluorescence Ratio | Before intradural dissection and during tumor dissection. | We aim to show that ICG fluorescence of the tumor intraoperatively is directly proportional to the contrast enhancement of the tumor from preoperative MRI. Enhancement is shown in ratio form on a scale of 0.01-1.00 showing enhancement ratios of 1. gland to internal carotid artery compared to blood fluorescence and 2. tumor tissue to blood fluorescence. Video recordings of intra-operative ICG fluorescence was compared to pre-operative imaging enhancements and compared in ratio format with a possible score of 0.01-1.00 The higher the ratio, the more closely the intra-operative fluorescence was related to the pre-operative imaging enhancements. 1.00 is considered to have the same enhancing brightness on pre-operative imaging as intra-operative video surveillance. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Near-infrared Light Nasal Endoscope Used With ICG ICG will be administered to identify the blood supply at two distinct stages of endonasal cranial base surgery and tumor dissection: before intradural dissection and during tumor dissection.
near-infrared light nasal endoscope used with ICG: Using the near-infrared light nasal endoscope with ICG will identify anatomical landmarks and and tumor characteristics to provide a clear demonstration of the blood supply. | 23 |
| Total | 23 |
Baseline characteristics
| Characteristic | Near-infrared Light Nasal Endoscope Used With ICG |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Region of Enrollment United States | 23 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
ICG Fluorescence Ratio
We aim to show that ICG fluorescence of the tumor intraoperatively is directly proportional to the contrast enhancement of the tumor from preoperative MRI. Enhancement is shown in ratio form on a scale of 0.01-1.00 showing enhancement ratios of 1. gland to internal carotid artery compared to blood fluorescence and 2. tumor tissue to blood fluorescence. Video recordings of intra-operative ICG fluorescence was compared to pre-operative imaging enhancements and compared in ratio format with a possible score of 0.01-1.00 The higher the ratio, the more closely the intra-operative fluorescence was related to the pre-operative imaging enhancements. 1.00 is considered to have the same enhancing brightness on pre-operative imaging as intra-operative video surveillance.
Time frame: Before intradural dissection and during tumor dissection.
Population: Patients undergoing tumor resection via endoscopic endonasal approach. Tumor pathologies included: pituitary adenoma (10), chordoma (4), tuberculum sellae meningioma (3), chondrosarcoma (1) estesioneuroblastoma (1) and Rathke's cleft cyst (1)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Near-infrared Light Nasal Endoscope Used With ICG | ICG Fluorescence Ratio | gland to internal carotid artery ratio | 0.92 Ratio | Standard Deviation 0.001 |
| Near-infrared Light Nasal Endoscope Used With ICG | ICG Fluorescence Ratio | tumor to internal carotid artery ratio | 0.82 Ratio | Standard Deviation 0.006 |