Pituitary AdenomaNCT04863456
Efficiency and Safety of Different Treatment Strategies in Adults With Pituitary Adenomas With Hypothalamic Involvement
A study testing Total resection, Staged resection and Subtotal resection followed by stereotactic radiation therapy in people with Pituitary Adenoma, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
Trial summary
Prospective and randomized evaluate efficiency and safety of different treatment strategies for hypothalamus-invading pituitary adenomas (HIPA) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pituitary Adenoma
- What is being tested?
- Total resection, Staged resection and Subtotal resection followed by stereotactic radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2021to 31 Dec 2024
- 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
- Suspected symptomatic or progressively growing pituitary adenoma with Hypothalamic Involvement
- Informed consent
Who cannot join
- No follow-up possible
- Emergency surgery without informed consent
Trial locations and contacts
No sites are listed yet.
About this study
Prospective and randomized evaluate efficiency and safety of different treatment strategies for hypothalamus-invading pituitary adenomas (HIPA)
Read the detailed description
There are various treatment strategies for hypothalamus-invading pituitary adenomas (HIPA), such as total resection (TR), subtotal resection with radiosurgery (STR+RS), etc. However,the optimal treatment of HIPA is still controversial. In this study, we want to evaluate the efficiency and safety of different treatment strategies in adults with HIPA.
- Conditions
- Pituitary Adenoma
- Being tested
- Total resection, Staged resection, Subtotal resection followed by stereotactic radiation therapy
- Keywords
- pituitary adenoma, treatment strategy, Hypothalamus
- Medical subject headings
- Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total resectionProcedure or surgery
Total resection of HIPA in a single surgery
Staged resectionProcedure or surgery
HIPA was resected subtotally at first time, and the tumor remnant was removed at a later date
Subtotal resection followed by stereotactic radiation therapyProcedure or surgery
HIPA was resected subtotally at first time, and the tumor remnant was controled by the stereotactic radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| HIPA group of Puget grade 1 | Experimental | the tumor abuting or displacing the hypothalamus in the preoperative MR images Receives: Procedure: Total resection; Procedure: Staged resection; Procedure: Subtotal resection followed by stereotactic radiation therapy |
| HIPA group of Puget grade 2 | Experimental | hypothalamic involvement (the hypothalamus is no longer identifiable) in the preoperative MR images Receives: Procedure: Total resection; Procedure: Staged resection; Procedure: Subtotal resection followed by stereotactic radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of QoL (Quality of Life, EQ-5D) for the first surgery
EQ-5D will be evaluated before the first surgery and after the first surgery in 2 years
Measured: baseline (before the first surgery), 2 years after the first surgery
Change of QoL (Quality of Life, EQ-5D) for the second intervention
EQ-5D will be evaluated before the second intervention and after the second intervention in 3 months
Measured: baseline (before the second intervention), 3 months after the second intervention
Secondary outcomes (4)
Change of Visual Acuity statue
Visual Acuity statue will be evaluated using Snellen's chart before the first surgery and after the first surgery in 2 years
Measured: baseline (before the first surgery), 2 years after the first surgery
Change of Visual Field statue
Visual Field statue will be evaluated using a Humphrey visual field analyser before the first surgery and after the first surgery in 2 years
Measured: baseline (before the first surgery), 2 years after the first surgery
Change of Hormone Replacement Therapy
Whether the Hormone Replacement Therapy was used (Yes or No) before the first surgery and after the first surgery in 2 years
Measured: baseline (before the first surgery), 2 years after the first surgery
Extent of resection
Volumetric analysis of tumor volume before the first surgery, intraoperatively and 3 months and 2 years after the first surgery will be performed. In addition, Tumor volume will be evaluated before the second intervention and intraoperatively. Gross total resection is defined as no tumor present in gadolinium enhanced T1 sequences.
Measured: baseline (before the first surgery), 2 years after the first surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start1 May 2021 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
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 Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tao Huang, PhD, MD, Study director, Department of Neurosurgery, Union hospital, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04863456
- Sponsor's protocol ID
- [2021]IEC-J(227)
- Status last verified
- Apr 2021
- First submitted
- 29 Mar 2021
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency and Safety of Different Treatment Strategies in Adults With Pituitary Adenomas With Hypothalamic Involvement
- ClinicalTrials.gov ID
- NCT04863456
- Acronym / sponsor ID
- [2021]IEC-J(227)
- Conditions
- Pituitary Adenoma
- Keywords
- pituitary adenoma, treatment strategy, Hypothalamus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 28 Apr 2021 (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.
Prospective and randomized evaluate efficiency and safety of different treatment strategies for hypothalamus-invading pituitary adenomas (HIPA)
Detailed description
There are various treatment strategies for hypothalamus-invading pituitary adenomas (HIPA), such as total resection (TR), subtotal resection with radiosurgery (STR+RS), etc. However,the optimal treatment of HIPA is still controversial. In this study, we want to evaluate the efficiency and safety of different treatment strategies in adults with HIPA.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIPA group of Puget grade 1 | Experimental | Procedure: Total resection, Procedure: Staged resection, Procedure: Subtotal resection followed by stereotactic radiation therapythe tumor abuting or displacing the hypothalamus in the preoperative MR images |
| HIPA group of Puget grade 2 | Experimental | Procedure: Total resection, Procedure: Staged resection, Procedure: Subtotal resection followed by stereotactic radiation therapyhypothalamic involvement (the hypothalamus is no longer identifiable) in the preoperative MR images |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Suspected symptomatic or progressively growing pituitary adenoma with Hypothalamic Involvement
- Informed consent
Key exclusion criteria (2 listed)
- No follow-up possible
- Emergency surgery without informed consent
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 |
|---|---|---|
| Total resectionTotal resection of HIPA in a single surgery | Procedure or surgery | HIPA group of Puget grade 1, HIPA group of Puget grade 2 |
| Staged resectionHIPA was resected subtotally at first time, and the tumor remnant was removed at a later date | Procedure or surgery | HIPA group of Puget grade 1, HIPA group of Puget grade 2 |
| Subtotal resection followed by stereotactic radiation therapyHIPA was resected subtotally at first time, and the tumor remnant was controled by the stereotactic radiation therapy | Procedure or surgery | HIPA group of Puget grade 1, HIPA group of Puget grade 2 |
Primary outcome
Change of QoL (Quality of Life, EQ-5D) for the first surgery
Time frame: baseline (before the first surgery), 2 years after the first surgery
EQ-5D will be evaluated before the first surgery and after the first surgery in 2 years
Change of QoL (Quality of Life, EQ-5D) for the second intervention
Time frame: baseline (before the second intervention), 3 months after the second intervention
EQ-5D will be evaluated before the second intervention and after the second intervention in 3 months
4 secondary outcomes
Change of Visual Acuity statue
Time frame: baseline (before the first surgery), 2 years after the first surgery
Change of Visual Field statue
Time frame: baseline (before the first surgery), 2 years after the first surgery
Change of Hormone Replacement Therapy
Time frame: baseline (before the first surgery), 2 years after the first surgery
Extent of resection
Time frame: baseline (before the first surgery), 2 years after the first surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
Related trials for Pituitary Adenoma
RecruitingObservational study
Evaluation and Treatment of Neurosurgical Disorders
Neurologic Disorders
RecruitingObservational study
Adrenal Diseases in the Population of Modena: A Clinical-Epidemiological Database of Patients Referred to the Adrenal Disorders Outpatient Clinic of the Clinical Unit of Endocrinology at the Modena University Hospital (AOU Modena)
Cushing s Syndrome, Cushing Disease
Active, not recruitingPhase 2
Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome
Cushing Syndrome
RecruitingPhase 4
68-Ga DOTATATE PET/MRI in the Diagnosis and Management of Somatostatin Receptor Positive CNS Tumors.
CNS Tumors, Meningioma
RecruitingEarly Phase 1
FET PET/CT Imaging To Localize Pituitary Adenomas In Cushing Disease
Cushing Disease, Pituitary Adenoma
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.
Tao Huang, PhD, MD study director
Department of Neurosurgery, Union hospital, Huazhong University of Science and Technology
Questions about this trial
What is this clinical trial studying?
A study testing Total resection, Staged resection and Subtotal resection followed by stereotactic radiation therapy in people with Pituitary Adenoma, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tao Huang, PhD, MD (027-85350819, neuroht@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of QoL (Quality of Life, EQ-5D) for the first surgery (time frame: baseline (before the first surgery), 2 years after the first surgery). The study lists 2 primary outcomes in all. 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 28 Apr 2021.