Long TermNCT07015645
Long-Term Outcomes of Hypopituitarism Following Gamma Knife Radiosurgery for Pituitary Adenomas
An observational study of Long Term and Hypopituitarism, run by Al-Azhar University at 1 site in Egypt.
Trial summary
This study aims to assess long-term outcomes of hypopituitarism following gamma knife radiosurgery (GKRS) for pituitary adenomas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long Term, Hypopituitarism, Gamma Knife Radiosurgery
- What is being tested?
- Gamma Knife Radiosurgery
- Type of treatment
- Surgery or procedure
- How many people
- 137 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 1 Jan 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This retrospective cohort study will be conducted in the Department of Neurosurgery, Al-Azhar University Hospital.
Who may be able to join
- Age ≥18 years.
- Both sexes.
- Patients treated with gamma knife radiosurgery (GKRS).
Who cannot join
- Patients with inadequate endocrine follow-up (<12 months).
- Patients who had undergone previous radiation therapy.
- Pituitary insufficiency which presents before gamma knife radiosurgery (GKRS).
- Patients without visible glands.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to assess long-term outcomes of hypopituitarism following gamma knife radiosurgery (GKRS) for pituitary adenomas.
Read the detailed description
Pituitary adenomas (PAs) are one of the most common intracranial neoplasms, accounting for 10-20% of diagnosed brain tumors.
Initial gamma knife radiosurgery (GKRS) can be an alternative treatment for selected NFPA patients with comorbidities, documented growth small tumors, cavernous sinus invasion, or advanced age.
Hypopituitarism is one of the most common complications of radiosurgery (Cordeiro et al., 2018). Long-term follow-up is crucial to assess new pituitary deficits. Typically, hypopituitarism presents within the first 2-4 years after the treatment with radiosurgery, but the risk of pituitary insufficiency increases to up to 80%. Reports on the highest incidence of new-onset hypopituitarism also mentioned the longest follow-up period.
- Being tested
- Gamma Knife Radiosurgery
- Medical subject headings
- Hypopituitarism, Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamma Knife RadiosurgeryProcedure or surgery
Patients received gamma knife radiosurgery (GKRS) treatment for pituitary adenomas.
| Study group | Role | What they receive |
|---|---|---|
| Pituitary Adenomas group | Patients received gamma knife radiosurgery (GKRS) treatment for pituitary adenomas. Receives: Procedure: Gamma Knife Radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of new-onset hypopituitarism
Prevalence of new-onset hypopituitarism will be recorded.
Measured: 5 years post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start1 Jan 2019
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long TermStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe 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
- Retrospective
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Awad Mohamed Hegab, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07015645
- Sponsor's protocol ID
- DFM-IRB 00012367-25-05-006
- Status last verified
- Jun 2025
- First submitted
- 3 Jun 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Outcomes of Hypopituitarism Following Gamma Knife Radiosurgery for Pituitary Adenomas
- ClinicalTrials.gov ID
- NCT07015645
- Acronym / sponsor ID
- DFM-IRB 00012367-25-05-006
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 11 Jun 2025 (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.
This study aims to assess long-term outcomes of hypopituitarism following gamma knife radiosurgery (GKRS) for pituitary adenomas.
Detailed description
Pituitary adenomas (PAs) are one of the most common intracranial neoplasms, accounting for 10-20% of diagnosed brain tumors.
Initial gamma knife radiosurgery (GKRS) can be an alternative treatment for selected NFPA patients with comorbidities, documented growth small tumors, cavernous sinus invasion, or advanced age.
Hypopituitarism is one of the most common complications of radiosurgery (Cordeiro et al., 2018). Long-term follow-up is crucial to assess new pituitary deficits. Typically, hypopituitarism presents within the first 2-4 years after the treatment with radiosurgery, but the risk of pituitary insufficiency increases to up to 80%. Reports on the highest incidence of new-onset hypopituitarism also mentioned the longest follow-up period.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pituitary Adenomas group | – | Procedure: Gamma Knife RadiosurgeryPatients received gamma knife radiosurgery (GKRS) treatment for pituitary adenomas. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective cohort study will be conducted in the Department of Neurosurgery, Al-Azhar University Hospital.
Key inclusion criteria (3 listed)
- Age ≥18 years.
- Both sexes.
- Patients treated with gamma knife radiosurgery (GKRS).
Key exclusion criteria (4 listed)
- Patients with inadequate endocrine follow-up (<12 months).
- Patients who had undergone previous radiation therapy.
- Pituitary insufficiency which presents before gamma knife radiosurgery (GKRS).
- Patients without visible glands.
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 |
|---|---|---|
| Gamma Knife RadiosurgeryPatients received gamma knife radiosurgery (GKRS) treatment for pituitary adenomas. | Procedure or surgery | Pituitary Adenomas group |
Primary outcome
Prevalence of new-onset hypopituitarism
Time frame: 5 years post-procedure
Prevalence of new-onset hypopituitarism will be recorded.
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 11 Jun 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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?
An observational study of Long Term and Hypopituitarism, run by Al-Azhar University at 1 site in Egypt.
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: finished, as of the sponsor's last update on 11 Jun 2025. 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 Egypt. 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?
Prevalence of new-onset hypopituitarism (time frame: 5 years post-procedure). 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 11 Jun 2025.