Pituitary AdenomaNCT05338125
Electrophysiology of the Human Pituitary Gland
A study testing Micro-electrode measurement in people with Pituitary Adenoma and Pituitary Tumor, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
Measurment of electrophysiological properties of the human pituitary gland during removal of a pituitary adenoma. Assessment if these properties are sufficient for intra-operative identification of different tissues. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pituitary Adenoma, Pituitary Tumor, Diabetes Insipidus Cranial Type
- What is being tested?
- Micro-electrode measurement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 Dec 2020to 9 Mar 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients undergoing transsphenoidal surgery for pituitary adenoma.
- Identification of the posterior lobe on preoperative MRI. This is most common in patients with micro-adenomas or small macroadenomas.
- Age >18 years
Who cannot join
- Emergency surgery
- Cognitive impairments
- Pregnancy
- Pre-existing diabetes insipidus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of the Posterior Lobe of the Human Pituitary Gland During Surgery Using Its Electrophysiological, Neural Signature
Measurment of electrophysiological properties of the human pituitary gland during removal of a pituitary adenoma. Assessment if these properties are sufficient for intra-operative identification of different tissues.
Read the detailed description
In this study, patients undergoing a surgical resection of a pituitary adenoma as part of standard care will undergo an extra measurement of the electrophysiological properties of the pituitary gland. A single-unit microlectrode will be introduced and placed in the adenoma tissue, anterior piuitary lobe and posterior pituitary lobe. Apart from this measurement, no other interventions are performed and standard care will continue. Six months after measurements the patients chart will be assessed for the occurrence of remission and endocrine deficiencies.
An assessment will be made if these properties are distinctive enough to allow intra-operative identification of the different tissues and thereby increase chances of maximal tumour removal and decrease chance of endocrine deficiencies.
- Conditions
- Pituitary Adenoma, Pituitary Tumor, Diabetes Insipidus Cranial Type, Endocrine; Deficiency
- Being tested
- Micro-electrode measurement
- Keywords
- Electrophysiology
- Medical subject headings
- Pituitary Neoplasms, Diabetes Insipidus, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micro-electrode measurementProcedure or surgery
Electrophysiological measurement with single-unit micro-electrode
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Patients undergoing the extra intra-operative electrophysiological measurement Receives: Procedure: Micro-electrode measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrophysiological properties
Electrophysiological properties of the human pituitary gland
Measured: Day 0
Secondary outcomes (2)
Endocrine remission
Occurrence of endocrine remission after surgery
Measured: 6 months postoperative
Endocrine deficiencies
Occurrence of endocrine deficiencies after surgery
Measured: 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start10 Dec 2020
- Primary completion9 Mar 2023
- Study completion9 Mar 2023
Why it stopped: too busy for recruitment
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 Leiden University Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot proof-of-concept study
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, wrvanfurth, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05338125
- Sponsor's protocol ID
- P19.032
- Status last verified
- Mar 2023
- First submitted
- 3 Nov 2021
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of the Posterior Lobe of the Human Pituitary Gland During Surgery Using Its Electrophysiological, Neural Signature
- ClinicalTrials.gov ID
- NCT05338125
- Acronym / sponsor ID
- P19.032
- Conditions
- Pituitary Adenoma, Pituitary Tumor, Diabetes Insipidus Cranial Type, Endocrine; Deficiency
- Keywords
- Electrophysiology
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: too busy for recruitment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 9 Mar 2023 (actual)
- Study completion
- 9 Mar 2023 (actual)
- First posted
- 20 Apr 2022 (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.
Measurment of electrophysiological properties of the human pituitary gland during removal of a pituitary adenoma. Assessment if these properties are sufficient for intra-operative identification of different tissues.
Detailed description
In this study, patients undergoing a surgical resection of a pituitary adenoma as part of standard care will undergo an extra measurement of the electrophysiological properties of the pituitary gland. A single-unit microlectrode will be introduced and placed in the adenoma tissue, anterior piuitary lobe and posterior pituitary lobe. Apart from this measurement, no other interventions are performed and standard care will continue. Six months after measurements the patients chart will be assessed for the occurrence of remission and endocrine deficiencies.
An assessment will be made if these properties are distinctive enough to allow intra-operative identification of the different tissues and thereby increase chances of maximal tumour removal and decrease chance of endocrine deficiencies.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot proof-of-concept study
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Procedure: Micro-electrode measurementPatients undergoing the extra intra-operative electrophysiological measurement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female patients undergoing transsphenoidal surgery for pituitary adenoma.
- Identification of the posterior lobe on preoperative MRI. This is most common in patients with micro-adenomas or small macroadenomas.
- Age >18 years
Key exclusion criteria (4 listed)
- Emergency surgery
- Cognitive impairments
- Pregnancy
- Pre-existing diabetes insipidus
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 |
|---|---|---|
| Micro-electrode measurementElectrophysiological measurement with single-unit micro-electrode | Procedure or surgery | Intervention arm |
Primary outcome
Electrophysiological properties
Time frame: Day 0
Electrophysiological properties of the human pituitary gland
2 secondary outcomes
Endocrine remission
Time frame: 6 months postoperative
Endocrine deficiencies
Time frame: 6 months postoperative
Results and safety
The study was stopped early (reason given: too busy for recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micro-electrode measurement in people with Pituitary Adenoma and Pituitary Tumor, run by Leiden University Medical Center at 1 site in Netherlands.
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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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 was stopped early (reason given: too busy for recruitment). Results are not available in the source record.
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?
Electrophysiological properties (time frame: Day 0). 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 13 Mar 2023.