Study Stopped
Pending additional funding
Utilization of iMRI for Transsphenoidal Resection of Pituitary Macroadenomas
A Single-center, Prospective, Randomized Controlled Trial Investigating the Utility if Intraoperative MRI in Transphenoidal Pituitary Surgery Off Macroadenomas.
1 other identifier
interventional
10
1 country
1
Brief 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. The investigators will then count the number of gross total resection in each group of patients and also the complications related to surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2015
CompletedFirst Posted
Study publicly available on registry
March 24, 2015
CompletedStudy Start
First participant enrolled
May 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2023
CompletedAugust 8, 2023
August 1, 2023
8.1 years
March 5, 2015
August 7, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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
24 hours after surgery
Secondary Outcomes (5)
Operative time
intraoperative
Frequency of post-operative CSF leak
30 days post surgery
Rate of Readmission
30 days post surgery
Length of anesthesia time
intraoperative
Rate of post-operative endocrinopathies
30 days post surgery
Study Arms (2)
No intra-operative MRI
PLACEBO COMPARATORPatients undergo transsphenoidal surgery without an intra-operative MRI.
intra-operative MRI
EXPERIMENTALPatients undergo transspheonidal surgery followed by intra-operative MRI.
Interventions
Intra-operative magnetic resonance imaging under general anesthesia
Routine transsphenoidal resection of pituitary macro adenomas
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03765, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Staff Physician
Study Record Dates
First Submitted
March 5, 2015
First Posted
March 24, 2015
Study Start
May 19, 2015
Primary Completion
July 1, 2023
Study Completion
July 1, 2023
Last Updated
August 8, 2023
Record last verified: 2023-08