Pituitary AdenomaScopeNCT03624114
Prediction of Sphenoid Septation in MRI Compared With CT and Intraoperative Findings During Endoscopic Pituitary Adenoma Surgery
An observational study of Pituitary Adenoma, run by University Hospital, Basel, Switzerland at 2 sites in 2 countries.
Trial summary
To investigate whether MRI is able to predict the exact anatomy and topography of the sphenoid sinus and its relationship to the sellar, parasellar und paraclinoid region and where CT yields more detailed information for the surgeon before trans-sphenoidal pituitary adenoma surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pituitary Adenoma
- What is being tested?
- comparison of data from MRI with data from CT compared with intraoperative data from endoscopic pituitary adenoma surgery
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jan 2018to 31 Dec 2021
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with sphenoidal surgery for an anterior skull base tumor with preoperative MRI, CT and intraoperative video during endoscopy (Centre A) and preoperative MRI and intraoperative video during endoscopy (Centre B). Consecutive recruitment of patients with planned endonasal endoscopic anterior skullbase tumors in daily clinical practice in both centres (A and B).
Who may be able to join
- lndicated trans-nasal trans-sphenoidal surgery for an anterior skull base tumour with preoperative baseline MRI (Centre A and B) and baseline CT (Centre A).
Who cannot join
- Previous trans-sphenoidal surgery
- Patients without CT, MRI or intraoperative endoscopic video
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Malaysia1 site
University of Malaya Medical Center and Specialist Center
Petaling Jaya, 59100
Switzerland1 site
University Hospital Basel, Neurochirurgie und Spinale Chirurgie
Basel, 4031
About this study
Official title: Prediction of Sphenoid Septation in Magnetic Resonance Imaging Compared With Computed Tomography and Intraoperative Findings During Endoscopic Pituitary Adenoma Surgery - a Prospective Observational Study
To investigate whether MRI is able to predict the exact anatomy and topography of the sphenoid sinus and its relationship to the sellar, parasellar und paraclinoid region and where CT yields more detailed information for the surgeon before trans-sphenoidal pituitary adenoma surgery.
Read the detailed description
The current research project addresses the question whether MRI alone is sufficient for preoperative planning and computer-assisted surgery (CAS) during standard trans-sphenoidal pituitary surgery and if situations can be identified, where additional CT yields more information for the surgeon.
A comparison of MRI with CT of the skull base or paranasal sinuses and intraoperative Video documentation of the anatomical site will be used.
50 patients operated the University hospital of Basel [USB] (Centre A) are consecutively included into the prospective part of the study. MRI is used to assess the standardized variables, confirmed by CT. Additionally, for the 50 prospectively collected patients, neuroimaging results are correlated with intraoperative evaluation during endoscopic trans-sphenoidal surgery or post-hoc with video analysis of the performed surgery.
Between 20-50 patients operated at the University of Malaya Medical Centre [UMMC] and Specialist Centre [UMSC] (Centre B)will be included retro- and prospectively . MRI is used to assess the standardized variables and the results are correlated with intraoperative evaluation during endoscopic trans-sphenoidal surgery or post-hoc with video analysis of the performed surgery.
- Conditions
- Pituitary Adenoma
- Being tested
- comparison of data from MRI with data from CT compared with intraoperative data from endoscopic pituitary adenoma surgery
- Keywords
- pituitary adenoma surgery, endoscopic transsphenoidal surgery, sphenoid septation
- Medical subject headings
- Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comparison of data from MRI with data from CT compared with intraoperative data from endoscopic pituitary adenoma surgeryProcedure or surgery
A comparison of MRI with CT of the skull base or paranasal sinuses and intraoperative Video documentation of the anatomical site will be used.
What is being measured
The primary outcome is the main question the study is designed to answer.
Posterior Insertion Site of the sphenoid septum at Cavernous Carotid and/or Optico-Carotid-Recess
To compare the relative performance of the MRI and the CT scan regarding posterior insertion site of the sphenoid septum at cavernous carotid and/or optico-carotid-recess. Neuroimaging results are correlated with intraoperative evaluation during endoscopic transsphenoidal surgery.
Measured: duration of endoscopic transsphenoidal surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start1 Jan 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary AdenomaStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel Röthlisberger, Dr. med, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03624114
- Sponsor's protocol ID
- 2018-00065; ch18Roethlisberger
- Other IDs
- 2018
- Acronym
- Scope
- Status last verified
- Aug 2022
- First submitted
- 7 Aug 2018
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Sphenoid Septation in Magnetic Resonance Imaging Compared With Computed Tomography and Intraoperative Findings During Endoscopic Pituitary Adenoma Surgery - a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03624114
- Acronym / sponsor ID
- Scope / 2018-00065; ch18Roethlisberger
- Conditions
- Pituitary Adenoma
- Keywords
- pituitary adenoma surgery, endoscopic transsphenoidal surgery, sphenoid septation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 9 Aug 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.
To investigate whether MRI is able to predict the exact anatomy and topography of the sphenoid sinus and its relationship to the sellar, parasellar und paraclinoid region and where CT yields more detailed information for the surgeon before trans-sphenoidal pituitary adenoma surgery.
Detailed description
The current research project addresses the question whether MRI alone is sufficient for preoperative planning and computer-assisted surgery (CAS) during standard trans-sphenoidal pituitary surgery and if situations can be identified, where additional CT yields more information for the surgeon.
A comparison of MRI with CT of the skull base or paranasal sinuses and intraoperative Video documentation of the anatomical site will be used.
50 patients operated the University hospital of Basel [USB] (Centre A) are consecutively included into the prospective part of the study. MRI is used to assess the standardized variables, confirmed by CT. Additionally, for the 50 prospectively collected patients, neuroimaging results are correlated with intraoperative evaluation during endoscopic trans-sphenoidal surgery or post-hoc with video analysis of the performed surgery.
Between 20-50 patients operated at the University of Malaya Medical Centre [UMMC] and Specialist Centre [UMSC] (Centre B)will be included retro- and prospectively . MRI is used to assess the standardized variables and the results are correlated with intraoperative evaluation during endoscopic trans-sphenoidal surgery or post-hoc with video analysis of the performed surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with sphenoidal surgery for an anterior skull base tumor with preoperative MRI, CT and intraoperative video during endoscopy (Centre A) and preoperative MRI and intraoperative video during endoscopy (Centre B). Consecutive recruitment of patients with planned endonasal endoscopic anterior skullbase tumors in daily clinical practice in both centres (A and B).
Key inclusion criteria (1 listed)
- lndicated trans-nasal trans-sphenoidal surgery for an anterior skull base tumour with preoperative baseline MRI (Centre A and B) and baseline CT (Centre A).
Key exclusion criteria (2 listed)
- Previous trans-sphenoidal surgery
- Patients without CT, MRI or intraoperative endoscopic video
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 |
|---|---|---|
| comparison of data from MRI with data from CT compared with intraoperative data from endoscopic pituitary adenoma surgeryA comparison of MRI with CT of the skull base or paranasal sinuses and intraoperative Video documentation of the anatomical site will be used. | Procedure or surgery | – |
Primary outcome
Posterior Insertion Site of the sphenoid septum at Cavernous Carotid and/or Optico-Carotid-Recess
Time frame: duration of endoscopic transsphenoidal surgery
To compare the relative performance of the MRI and the CT scan regarding posterior insertion site of the sphenoid septum at cavernous carotid and/or optico-carotid-recess. Neuroimaging results are correlated with intraoperative evaluation during endoscopic transsphenoidal 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 3 Aug 2022.
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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.
Michel Röthlisberger, Dr. med principal investigator
University Hospital, Basel, Switzerland
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pituitary Adenoma, run by University Hospital, Basel, Switzerland at 2 sites in 2 countries.
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 1 inclusion and 2 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 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malaysia, Switzerland. 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?
Posterior Insertion Site of the sphenoid septum at Cavernous Carotid and/or Optico-Carotid-Recess (time frame: duration of endoscopic transsphenoidal surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2022.