Pituitary AdenomaNCT04076046
Multicentric Prospective Validation of the Zurich Pituitary Score
An observational study of Pituitary Adenoma, run by University of Zurich at 10 sites in 6 countries.
Trial summary
Predictive analytics for GTR, EOR and RV are useful in surgical decision-making, particularly whenever there is no unequivocal indication for surgery. Several factors have been shown to have a role in predicting GTR. Among these, the Knosp classification has proven over the years to be a good predictor of GTR. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pituitary Adenoma
- How many people
- 408 participants
- Where
- 10 sitesin 6 countries
- Study dates
- 1 Nov 2019to 1 Dec 2021
- How long will I take part?
- 3 Months
- 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: Consecutive serie of patients undergoing endoscopic transsphenoidal pituitary adenoma surgery
Who may be able to join
- Patients harboring suspected pituitary adenoma.
- Patients undergoing endoscopic transsphenoidal surgery
- Preoperative MRI including at least one volumetric sequence (i.e. MPRAGE or SPGR) with gadolinium with possibility for coronal reconstructions
- Postoperative MRI (2-4 months postoperative) including at least one volumetric sequence (i.e. MPRAGE or SPGR) with Gadolinium with possibility for coronal reconstructions
Who cannot join
- Patients undergoing combined or transcranial operations
- Patients for whom a biopsy only is planned
- Patients by whom histology does not confirm the diagnosis of pituitary adenoma
Trial locations and contacts
10 sites in 6 countries.
10 sites in 6 countries
Italy4 sites
IRCCS Istituto delle Scienze Neurologiche di Bologna
Bologna
Azienda Ospedaliera Universitaria Careggi
Florence
Universita' degli Studi Federico II
Naples
Reparto di Neurochirurgia, Ospedale di Circolo e Fondazione Macchi, Universita' dell'Insubria
Varese
United States1 site
Donald and Barbara Zucker School of Medicine at Hofstra/Northwell
New York, New York, 11030
Czechia1 site
Department of Neurosurgery and Neurooncology, First Faculty of Medicine, Charles University and Military University Hospital
Prague
About this study
Predictive analytics for GTR, EOR and RV are useful in surgical decision-making, particularly whenever there is no unequivocal indication for surgery. Several factors have been shown to have a role in predicting GTR. Among these, the Knosp classification has proven over the years to be a good predictor of GTR. The score is based on the lateral extension of the adenoma in relation the the intracranial bedding of the internal carotid artery. However, recent literature has demonstrated that the Knosp classification suffers from relatively poor interrater agreement. Moreover the classification was conceived in an era when endoscopic techniques were not available: nowadays endoscopic technique allows visualization and possibly also reaching portions of adenoma which at the time when the Knosp classification was introduced were simply not possible. Lastly, the efficacy of the Knosp's score in predicting also EOR and RV has never been tested.
Recently a new score - the Zurich Pituitary Score (ZPS) has been proposed at the University Hospital of Zürich (USZ). The score has proved in the examined series to be more powerful than the Knosp classification in predicting GTR, EOR and RV. A good interrater agreement was also demonstrated. The score however, has been validated only in a monocentric setting with a limited number of patients. The aim of this study is to assess the (1) predictive ability of the ZPS for GTR, EOR, and RV, and (2) the inter-rater agreement of the ZPS in an external validation study.
Read the detailed description
In transsphenoidal surgery (TSS) for pituitary adenoma (PA), gross total resection (GTR) is often the target since it has been shown to relevantly influence long term patient outcome. This applies both to functioning adenomas (FA) as well as to non-functioning adenomas (NFPA). Mounting evidence shows that in cases where GTR is not achievable, maximizing extent of resection (EOR) is still highly desirable, particularly in case of FA, with the aim of obtaining the smallest possible residual volume (RV).
Predictive analytics for GTR, EOR and RV are useful in surgical decision-making, particularly whenever there is no unequivocal indication for surgery. Several factors have been shown to have a role in predicting GTR. Among these, the Knosp classification has proven over the years to be a good predictor of GTR. The score is based on the lateral extension of the adenoma in relation the the intracranial bedding of the internal carotid artery. However, recent literature has demonstrated that the Knosp classification suffers from relatively poor interrater agreement. Moreover the classification was conceived in an era when endoscopic techniques were not available: nowadays endoscopic technique allows visualization and possibly also reaching portions of adenoma which at the time when the Knosp classification was introduced were simply not possible. Lastly, the efficacy of the Knosp's score in predicting also EOR and RV has never been tested.
Recently a new score - the Zurich Pituitary Score (ZPS) has been proposed at the University Hospital of Zürich (USZ). The score has proved in the examined series to be more powerful than the Knosp classification in predicting GTR, EOR and RV. A good interrater agreement was also demonstrated. The score however, has been validated only in a monocentric setting with a limited number of patients. The aim of this study is to assess the (1) predictive ability of the ZPS for GTR, EOR, and RV, and (2) the inter-rater agreement of the ZPS in an external validation study.
- Conditions
- Pituitary Adenoma
- Keywords
- pituitary adenoma endoscopic surgery zurich pituitary score
- Medical subject headings
- Pituitary Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Total Resection
Gross Total Resection on magnetic resonance imaging
Measured: 2 to 4 months postoperatively
Extent of Resection
Percentage of removed adenoma volume on magnetic resonance imaging
Measured: 2 to 4 months postoperatively
Residual Adenoma Volume
Percentage of original adenoma volume still visible at the postoperative magnetic resonance imaging
Measured: 2 to 4 months postoperatively
Zurich Pituitary Score
Four-tier score as follows:
Grade Criteria I R < 0.75 II 0.75 < R < 1.25 III 1.25 < R IV Encasement of the intracavernous ICA
R = ratio of maximum horizontal tumor diameter divided by the minimum intercarotid distance at the intracavernous horizontal C4 segment of the ICA.
Measured: On preoperative MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2019
- Study start1 Nov 2019
- Primary completion1 May 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pituitary AdenomaStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- 408 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlo Serra, University of Zurich
- Investigators
- Carlo Serra, MD, Study director, Klinik für Neurochirurgie, UniversitätsSpital Zürich, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04076046
- Sponsor's protocol ID
- ZPS prospective validation
- Status last verified
- Dec 2021
- First submitted
- 29 Aug 2019
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Staartjes VE, Serra C, Maldaner N, Muscas G, Tschopp O, Soyka MB, Holzmann D, Regli L. The Zurich Pituitary Score predicts utility of intraoperative high-field magnetic resonance imaging in transsphenoidal pituitary adenoma surgery. Acta Neurochir (Wien). 2019 Oct;161(10):2107-2115. doi: 10.1007/s00701-019-04018-9. Epub 2019 Aug 7.
PubMed 31392567Serra C, Staartjes VE, Maldaner N, Muscas G, Akeret K, Holzmann D, Soyka MB, Schmid C, Regli L. Predicting extent of resection in transsphenoidal surgery for pituitary adenoma. Acta Neurochir (Wien). 2018 Nov;160(11):2255-2262. doi: 10.1007/s00701-018-3690-x. Epub 2018 Sep 29.
PubMed 30267209
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Prospective Validation of the Zurich Pituitary Score
- ClinicalTrials.gov ID
- NCT04076046
- Acronym / sponsor ID
- ZPS prospective validation
- Conditions
- Pituitary Adenoma
- Keywords
- pituitary adenoma endoscopic surgery zurich pituitary score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 3 Sep 2019 (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.
Predictive analytics for GTR, EOR and RV are useful in surgical decision-making, particularly whenever there is no unequivocal indication for surgery. Several factors have been shown to have a role in predicting GTR. Among these, the Knosp classification has proven over the years to be a good predictor of GTR. The score is based on the lateral extension of the adenoma in relation the the intracranial bedding of the internal carotid artery. However, recent literature has demonstrated that the Knosp classification suffers from relatively poor interrater agreement. Moreover the classification was conceived in an era when endoscopic techniques were not available: nowadays endoscopic technique allows visualization and possibly also reaching portions of adenoma which at the time when the Knosp classification was introduced were simply not possible. Lastly, the efficacy of the Knosp's score in predicting also EOR and RV has never been tested.
Recently a new score - the Zurich Pituitary Score (ZPS) has been proposed at the University Hospital of Zürich (USZ). The score has proved in the examined series to be more powerful than the Knosp classification in predicting GTR, EOR and RV. A good interrater agreement was also demonstrated. The score however, has been validated only in a monocentric setting with a limited number of patients. The aim of this study is to assess the (1) predictive ability of the ZPS for GTR, EOR, and RV, and (2) the inter-rater agreement of the ZPS in an external validation study.
Detailed description
In transsphenoidal surgery (TSS) for pituitary adenoma (PA), gross total resection (GTR) is often the target since it has been shown to relevantly influence long term patient outcome. This applies both to functioning adenomas (FA) as well as to non-functioning adenomas (NFPA). Mounting evidence shows that in cases where GTR is not achievable, maximizing extent of resection (EOR) is still highly desirable, particularly in case of FA, with the aim of obtaining the smallest possible residual volume (RV).
Predictive analytics for GTR, EOR and RV are useful in surgical decision-making, particularly whenever there is no unequivocal indication for surgery. Several factors have been shown to have a role in predicting GTR. Among these, the Knosp classification has proven over the years to be a good predictor of GTR. The score is based on the lateral extension of the adenoma in relation the the intracranial bedding of the internal carotid artery. However, recent literature has demonstrated that the Knosp classification suffers from relatively poor interrater agreement. Moreover the classification was conceived in an era when endoscopic techniques were not available: nowadays endoscopic technique allows visualization and possibly also reaching portions of adenoma which at the time when the Knosp classification was introduced were simply not possible. Lastly, the efficacy of the Knosp's score in predicting also EOR and RV has never been tested.
Recently a new score - the Zurich Pituitary Score (ZPS) has been proposed at the University Hospital of Zürich (USZ). The score has proved in the examined series to be more powerful than the Knosp classification in predicting GTR, EOR and RV. A good interrater agreement was also demonstrated. The score however, has been validated only in a monocentric setting with a limited number of patients. The aim of this study is to assess the (1) predictive ability of the ZPS for GTR, EOR, and RV, and (2) the inter-rater agreement of the ZPS in an external validation study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive serie of patients undergoing endoscopic transsphenoidal pituitary adenoma surgery
Key inclusion criteria (4 listed)
- Patients harboring suspected pituitary adenoma.
- Patients undergoing endoscopic transsphenoidal surgery
- Preoperative MRI including at least one volumetric sequence (i.e. MPRAGE or SPGR) with gadolinium with possibility for coronal reconstructions
- Postoperative MRI (2-4 months postoperative) including at least one volumetric sequence (i.e. MPRAGE or SPGR) with Gadolinium with possibility for coronal reconstructions
Key exclusion criteria (3 listed)
- Patients undergoing combined or transcranial operations
- Patients for whom a biopsy only is planned
- Patients by whom histology does not confirm the diagnosis of pituitary adenoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gross Total Resection
Time frame: 2 to 4 months postoperatively
Gross Total Resection on magnetic resonance imaging
Extent of Resection
Time frame: 2 to 4 months postoperatively
Percentage of removed adenoma volume on magnetic resonance imaging
Residual Adenoma Volume
Time frame: 2 to 4 months postoperatively
Percentage of original adenoma volume still visible at the postoperative magnetic resonance imaging
Zurich Pituitary Score
Time frame: On preoperative MRI
Four-tier score as follows: Grade Criteria I R < 0.75 II 0.75 < R < 1.25 III 1.25 < R IV Encasement of the intracavernous ICA R = ratio of maximum horizontal tumor diameter divided by the minimum intercarotid distance at the intracavernous horizontal C4 segment of the ICA.
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 17 Dec 2021.
- Background: PubMed 31392567Staartjes VE, Serra C, Maldaner N, Muscas G, Tschopp O, Soyka MB, Holzmann D, Regli L. The Zurich Pituitary Score predicts utility of intraoperative high-field magnetic resonance imaging in transsphenoidal pituitary adenoma surgery. Acta Neurochir (Wien). 2019 Oct;161(10):2107-2115. doi: 10.1007/s00701-019-04018-9. Epub 2019 Aug 7.
- Background: PubMed 30267209Serra C, Staartjes VE, Maldaner N, Muscas G, Akeret K, Holzmann D, Soyka MB, Schmid C, Regli L. Predicting extent of resection in transsphenoidal surgery for pituitary adenoma. Acta Neurochir (Wien). 2018 Nov;160(11):2255-2262. doi: 10.1007/s00701-018-3690-x. Epub 2018 Sep 29.
- Individual participant dataSharing planned: No
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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.
Carlo Serra, MD study director
Klinik für Neurochirurgie, UniversitätsSpital Zürich, Switzerland
10 sites in 6 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 of Zurich at 10 sites in 6 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 4 inclusion and 3 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 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Italy, Switzerland, United States, Austria, Canada and 1 more country. 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?
Gross Total Resection (time frame: 2 to 4 months postoperatively). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04076046, which also lists 2 linked publications.
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 17 Dec 2021.