Pituitary MacroadenomaNCT02396810
Utilization of iMRI for Transsphenoidal Resection of Pituitary Macroadenomas
A study testing intra-operative MRI and Transsphenoidal resection of pituitary macroadenoma in people with Pituitary Macroadenoma, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
The investigators are studying the utility of intra-operative magnetic resonance imaging (iMRI) during transsphenoidal pituitary surgery for large macroadenomas by randomizing patients to either an intra-operative MRI after resection, or no intra-operative MRI. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pituitary Macroadenoma
- What is being tested?
- intra-operative MRI and Transsphenoidal resection of pituitary macroadenoma
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2015to 1 Jul 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18-90
- Capable of giving informed consent
- Elect for transsphenoidal surgery
- Has pre-operative MRI demonstrating pituitary tumor that is:
- deemed resectable using a transsphenoidal approach and
- has a maximal diameter equal to or greater than 15 mm.
- No contraindications for MRI.
Who cannot join
- Children (age < 18)
- Not able to give consent
- No pituitary tumor visible on MRI or an adenoma measuring less than 15mm in maximal dimension.
- Unable to tolerate MRI
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03765
About this study
Official title: A Single-center, Prospective, Randomized Controlled Trial Investigating the Utility if Intraoperative MRI in Transphenoidal Pituitary Surgery Off Macroadenomas.
The investigators are studying the utility of intra-operative magnetic resonance imaging (iMRI) during transsphenoidal pituitary surgery for large macroadenomas by randomizing patients to either an intra-operative MRI after resection, or no intra-operative MRI. The investigators will then count the number of gross total resection in each group of patients and also the complications related to surgery.
- Conditions
- Pituitary Macroadenoma
- Being tested
- intra-operative MRI, Transsphenoidal resection of pituitary macroadenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intra-operative MRIOther
Intra-operative magnetic resonance imaging under general anesthesia
Transsphenoidal resection of pituitary macroadenomaProcedure or surgery
Routine transsphenoidal resection of pituitary macro adenomas
| Study group | Role | What they receive |
|---|---|---|
| No intra-operative MRI | Placebo comparator | Patients undergo transsphenoidal surgery without an intra-operative MRI. Receives: Procedure: Transsphenoidal resection of pituitary macroadenoma |
| intra-operative MRI | Experimental | Patients undergo transspheonidal surgery followed by intra-operative MRI. Receives: Other: intra-operative MRI; Procedure: Transsphenoidal resection of pituitary macroadenoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of gross total or maximal resection
Determine whether use of iMRI in transsphenoidal pituitary surgery for pituitary macroadenomas significantly increases the rate of maximal resection
Measured: 24 hours after surgery
Secondary outcomes (5)
Operative time
Length of operation
Measured: intraoperative
Frequency of post-operative CSF leak
Frequency of post-operative Cerebrospinal Fluid (CSF) leak
Measured: 30 days post surgery
Rate of Readmission
Frequency of readmission
Measured: 30 days post surgery
Length of anesthesia time
Length of time participant is under anesthesia
Measured: intraoperative
Rate of post-operative endocrinopathies
Rate of post-operative endocrinopathies
Measured: 30 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study start19 May 2015
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Why it stopped: Pending additional funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary MacroadenomaStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nathan E. Simmons, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02396810
- Sponsor's protocol ID
- STUDY00028376 D14236
- Status last verified
- Aug 2023
- First submitted
- 5 Mar 2015
- Last updated
- 8 Aug 2023
- 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 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Prospective, Randomized Controlled Trial Investigating the Utility if Intraoperative MRI in Transphenoidal Pituitary Surgery Off Macroadenomas.
- ClinicalTrials.gov ID
- NCT02396810
- Acronym / sponsor ID
- STUDY00028376 D14236
- Conditions
- Pituitary Macroadenoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Pending additional funding
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 19 May 2015 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 24 Mar 2015 (estimated)
- 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.
The investigators are studying the utility of intra-operative magnetic resonance imaging (iMRI) during transsphenoidal pituitary surgery for large macroadenomas by randomizing patients to either an intra-operative MRI after resection, or no intra-operative MRI. The investigators will then count the number of gross total resection in each group of patients and also the complications related to surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No intra-operative MRI | Placebo comparator | Procedure: Transsphenoidal resection of pituitary macroadenomaPatients undergo transsphenoidal surgery without an intra-operative MRI. |
| intra-operative MRI | Experimental | Other: intra-operative MRI, Procedure: Transsphenoidal resection of pituitary macroadenomaPatients undergo transspheonidal surgery followed by intra-operative MRI. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults 18-90
- Capable of giving informed consent
- Elect for transsphenoidal surgery
- Has pre-operative MRI demonstrating pituitary tumor that is:
- No contraindications for MRI.
Key exclusion criteria (4 listed)
- Children (age < 18)
- Not able to give consent
- No pituitary tumor visible on MRI or an adenoma measuring less than 15mm in maximal dimension.
- Unable to tolerate MRI
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 |
|---|---|---|
| intra-operative MRIIntra-operative magnetic resonance imaging under general anesthesia | Other | intra-operative MRI |
| Transsphenoidal resection of pituitary macroadenomaRoutine transsphenoidal resection of pituitary macro adenomas | Procedure or surgery | No intra-operative MRI, intra-operative MRI |
Primary outcome
Rate of gross total or maximal resection
Time frame: 24 hours after surgery
Determine whether use of iMRI in transsphenoidal pituitary surgery for pituitary macroadenomas significantly increases the rate of maximal resection
5 secondary outcomes
Operative time
Time frame: intraoperative
Frequency of post-operative CSF leak
Time frame: 30 days post surgery
Rate of Readmission
Time frame: 30 days post surgery
Length of anesthesia time
Time frame: intraoperative
Rate of post-operative endocrinopathies
Time frame: 30 days post surgery
Results and safety
The study was stopped early (reason given: Pending additional funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
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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 intra-operative MRI and Transsphenoidal resection of pituitary macroadenoma in people with Pituitary Macroadenoma, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
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 7 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 8 Aug 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 United States. 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. Some participants in this study may receive a placebo. 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: Pending additional funding). 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?
Rate of gross total or maximal resection (time frame: 24 hours after surgery). 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 8 Aug 2023.