NCT07809178

Brief Summary

The goal of this observational study is to learn about the treatment strategies for tumor in sellar region with unruptured intracranial aneurysms in the Chinese population. The main question it aims to answer is: For patients with tumor in sellar region combined with unruptured intracranial aneurysms, which condition should be treated first?

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
608

participants targeted

Target at P75+ for all trials

Timeline
60mo left

Started Sep 2026

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Sep 2026Sep 2031

First Submitted

Initial submission to the registry

August 17, 2026

Completed
15 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 9, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2031

Last Updated

September 9, 2026

Status Verified

September 1, 2026

Enrollment Period

2 years

First QC Date

August 17, 2026

Last Update Submit

September 2, 2026

Conditions

Keywords

Tumor in sellar regionUnruptured intracranial aneurysms

Outcome Measures

Primary Outcomes (2)

  • Aneurysm progression

    The diameter of aneurysm neck, the diameter of aneurysm dome, the volume of aneurysm, aneurysm rupture status

    From enrollment to the end of treatment at 24 months

  • Tumor related complication and progression

    The related complication and progression of tumor in sellar region: pituitary hormone level, visual acuity and visual field, hydrocephalus and tumor recurrence.

    From enrollment to the end of treatment at 24 months

Study Arms (3)

Priority to Tumor

Tumor resection followed by aneurysm treatment

Procedure: Tumor resection followed by aneurysm treatment

Priority to Aneurysm

Aneurysm treatment followed by tumor resection

Procedure: Aneurysm treatment followed by tumor resection

Only Tumor

Tumor resection without aneurysm treatment but observation

Other: Observation

Interventions

Tumor resection followed by aneurysm treatment

Priority to Tumor

Aneurysm treatment followed by tumor resection

Priority to Aneurysm

Tumor resection without aneurysm treatment but observation

Only Tumor

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed of tumor in sellar region with unruptured intracranial aneurysms in the Chinese population

You may qualify if:

  • Preoperative enhanced head MRI showing a suspected diagnosis of a sella region lesion, and preoperative head CTA/DSA confirming an unruptured intracranial aneurysm.
  • Patients with primary sella region tumor and unruptured intracranial aneurysms that have not previously accepted surgical treatment.
  • Patients with tumor in sellar region requiring craniotomy or endoscopic transnasal surgery and/or an aneurysm requiring craniotomy, endovascular treatment, or observation only.
  • The patients are in good general health, without severe underlying medical conditions, and capable of tolerating surgical treatment.
  • Patients or their legal guardians have signed an informed consent form and voluntarily agreed to participate in the clinical trial.

You may not qualify if:

  • Patients with recurrent sella region tumors.
  • Patients with previously treated intracranial aneurysm.
  • Pregnant or breastfeeding women.
  • Any other condition that, in the investigator's judgment, makes the patient unsuitable for trial participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tiantan Hospital affiliated to Capital Medical University

Beijing, China, 100070, China

Location

Related Publications (5)

  • Almeida Silva JM, Campos RR, Souza RR, Sette Dos Santos ME, Aguiar GB. Spontaneous subarachnoid haemorrhage from rupture of an anterior communicating artery aneurysm in a patient with pituitary macroadenoma. Neurocirugia (Astur). 2014 Mar-Apr;25(2):81-5. doi: 10.1016/j.neucir.2013.03.005. Epub 2013 Jul 9.

  • Schwab KE, Gailloud P, Wyse G, Tamargo RJ. Limitations of magnetic resonance imaging and magnetic resonance angiography in the diagnosis of intracranial aneurysms. Neurosurgery. 2008 Jul;63(1):29-34; discussion 34-5. doi: 10.1227/01.NEU.0000335068.53190.46.

  • Oshino S, Nishino A, Suzuki T, Arita H, Tateishi A, Matsumoto K, Shimokawa T, Kinoshita M, Yoshimine T, Saitoh Y. Prevalence of cerebral aneurysm in patients with acromegaly. Pituitary. 2013 Jun;16(2):195-201. doi: 10.1007/s11102-012-0404-x.

  • de Sena Barbosa MG, Otavio da Silva V, Santos Ferreira LH, de Souza RLV, Pipek LZ, de Oliveira Almeida G, Figueiredo EG, Rabelo NN, Chaurasia B. Intracranial aneurysm coexisting with pituitary adenoma: a systematic review. Ann Med Surg (Lond). 2024 Oct 25;86(12):7232-7237. doi: 10.1097/MS9.0000000000002692. eCollection 2024 Dec.

  • Cai K, Jia Y, Jin L, Qiao N, Xiao Y, Wu W, Ru S, Liu F, Liu C, Cao L, Gui S. Adult craniopharyngioma concomitant with unruptured intracranial aneurysms: incidence, risk factors, and treatment strategies. J Neurosurg. 2024 Jun 14;141(6):1712-1722. doi: 10.3171/2024.3.JNS232258. Print 2024 Dec 1.

MeSH Terms

Conditions

CraniopharyngiomaMeningiomaGerminomaCentral Nervous System CystsChordomaHypothalamic Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNeoplasms, Vascular TissueMeningeal NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNervous System DiseasesNervous System MalformationsCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSupratentorial NeoplasmsBrain NeoplasmsBrain DiseasesCentral Nervous System DiseasesHypothalamic Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 17, 2026

First Posted

September 9, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2031

Last Updated

September 9, 2026

Record last verified: 2026-09

Locations