Unruptured Intracranial AneurysmsChTTSRUIANCT07809178
China Treatment Trial for Tumor in Sellar Region With Unruptured Intracranial Aneurysm
An observational study of Unruptured Intracranial Aneurysms and Pituitary Neuroendocrine Tumor, run by Cheng sen at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Unruptured Intracranial Aneurysms, Pituitary Neuroendocrine Tumor, Craniopharyngioma
- What is being tested?
- Tumor resection followed by aneurysm treatment, Aneurysm treatment followed by tumor resection and Observation
- Type of treatment
- Surgery or procedure
- How many people
- 608 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2026to 1 Sep 2031
- How long will I take part?
- 2 Years
- Phase
- Observational
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed of tumor in sellar region with unruptured intracranial aneurysms in the Chinese population
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tiantan Hospital affiliated to Capital Medical University
Beijing, China, 100070
About this study
Official title: Treatment Strategies for Tumor in Sellar Region With Unruptured Intracranial Aneurysms in the Chinese Population
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?
Read the detailed description
The goal of this observational study is to clarify the treatment strategies for tumor in sellar region with unruptured intracranial aneurysms in the Chinese population aged from 18 to 75. The main question it aims to answer is:
- What is the appropriate treatment strategy for patients diagnosed with tumor in sellar region with unruptured intracranial aneurysms?
- Should the tumor be resected first followed by aneurysm treatment, or should the aneurysm be treated prior to tumor resection? Alternatively, is tumor resection alone with regular observation of the aneurysm a viable option?
- What are the patient's intraoperative risks, postoperative complications, and prognosis?
Participants are required to:
- Provide detailed medical records.
- Complete laboratory tests and imaging examinations at scheduled time points and cooperate with neurosurgeons for follow-up visits after the relevant treatments.
This is an observational study. It solely collects patients' pre-operative, intra-operative, and post-operative follow-up information and does not influence the patient's treatment process or clinical decision-making.
- Conditions
- Unruptured Intracranial Aneurysms, Pituitary Neuroendocrine Tumor, Craniopharyngioma, Meningioma, Germinoma, Rathke Cleft Cysts
- Being tested
- Tumor resection followed by aneurysm treatment, Aneurysm treatment followed by tumor resection, Observation
- Keywords
- Tumor in sellar region, Unruptured intracranial aneurysms
- Medical subject headings
- Craniopharyngioma, Meningioma, Germinoma, Central Nervous System Cysts, Chordoma, Hypothalamic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor resection followed by aneurysm treatmentProcedure or surgery
Tumor resection followed by aneurysm treatment
Aneurysm treatment followed by tumor resectionProcedure or surgery
Aneurysm treatment followed by tumor resection
ObservationOther
Tumor resection without aneurysm treatment but observation
| Study group | Role | What they receive |
|---|---|---|
| Priority to Tumor | Tumor resection followed by aneurysm treatment Receives: Procedure: Tumor resection followed by aneurysm treatment | |
| Priority to Aneurysm | Aneurysm treatment followed by tumor resection Receives: Procedure: Aneurysm treatment followed by tumor resection | |
| Only Tumor | Tumor resection without aneurysm treatment but observation Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aneurysm progression
The diameter of aneurysm neck, the diameter of aneurysm dome, the volume of aneurysm, aneurysm rupture status
Measured: 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.
Measured: From enrollment to the end of treatment at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start20 Oct 2026
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Unruptured Intracranial AneurysmsStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 608 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Cheng sen
- Sponsor type
- University, hospital or other
- Collaborators
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, West China Hospital, Xijing Hospital, Shandong Provincial Hospital, The First Affiliated Hospital of Anhui Medical University, First Affiliated Hospital of Chongqing Medical University, Shengjing Hospital, Lanzhou University Second Hospital, The First Hospital of Jilin University, People's Hospital of Xinjiang Uygur Autonomous Region, Guangdong Provincial Hospital of Traditional Chinese Medicine, Huashan Hospital, Jinling Hospital, China
- Responsible party
- Sponsor-investigator, Cheng sen, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07809178
- Sponsor's protocol ID
- HX-B-2025024
- Acronym
- ChTTSRUIA
- Status last verified
- Oct 2026
- First submitted
- 17 Aug 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The IPD used and/or analyzed during the current study are available from the researcher on reasonable request.
Publications
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.
PubMed 23845268Schwab 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.
PubMed 18728566Oshino 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.
PubMed 22752346de 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.
PubMed 39649870Cai 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.
PubMed 38875730