Back to resultsUtilization of iMRI for Transsphenoidal Resection of Pituitary Macroadenomas
Primary Purpose
Pituitary Macroadenoma
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
intra-operative MRI
Transsphenoidal resection of pituitary macroadenoma
Sponsored by
About this trial
This is an interventional diagnostic trial for Pituitary Macroadenoma
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Dartmouth Hitchcock Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
No intra-operative MRI
intra-operative MRI
Arm Description
Patients undergo transsphenoidal surgery without an intra-operative MRI.
Patients undergo transspheonidal surgery followed by intra-operative MRI.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Operative time
Length of operation
Frequency of post-operative CSF leak
Frequency of post-operative Cerebrospinal Fluid (CSF) leak
Rate of Readmission
Frequency of readmission
Length of anesthesia time
Length of time participant is under anesthesia
Rate of post-operative endocrinopathies
Rate of post-operative endocrinopathies
Full Information
NCT ID
NCT02396810
First Posted
March 5, 2015
Last Updated
August 7, 2023
Sponsor
Dartmouth-Hitchcock Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02396810
Brief Title
Utilization of iMRI for Transsphenoidal Resection of Pituitary Macroadenomas
Official Title
A Single-center, Prospective, Randomized Controlled Trial Investigating the Utility if Intraoperative MRI in Transphenoidal Pituitary Surgery Off Macroadenomas.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Pending additional funding
Study Start Date
May 19, 2015 (Actual)
Primary Completion Date
July 1, 2023 (Actual)
Study Completion Date
July 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pituitary Macroadenoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No intra-operative MRI
Arm Type
Placebo Comparator
Arm Description
Patients undergo transsphenoidal surgery without an intra-operative MRI.
Arm Title
intra-operative MRI
Arm Type
Experimental
Arm Description
Patients undergo transspheonidal surgery followed by intra-operative MRI.
Intervention Type
Other
Intervention Name(s)
intra-operative MRI
Intervention Description
Intra-operative magnetic resonance imaging under general anesthesia
Intervention Type
Procedure
Intervention Name(s)
Transsphenoidal resection of pituitary macroadenoma
Intervention Description
Routine transsphenoidal resection of pituitary macro adenomas
Primary Outcome Measure Information:
Title
Rate of gross total or maximal resection
Description
Determine whether use of iMRI in transsphenoidal pituitary surgery for pituitary macroadenomas significantly increases the rate of maximal resection
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
Operative time
Description
Length of operation
Time Frame
intraoperative
Title
Frequency of post-operative CSF leak
Description
Frequency of post-operative Cerebrospinal Fluid (CSF) leak
Time Frame
30 days post surgery
Title
Rate of Readmission
Description
Frequency of readmission
Time Frame
30 days post surgery
Title
Length of anesthesia time
Description
Length of time participant is under anesthesia
Time Frame
intraoperative
Title
Rate of post-operative endocrinopathies
Description
Rate of post-operative endocrinopathies
Time Frame
30 days post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Facility Information:
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03765
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Utilization of iMRI for Transsphenoidal Resection of Pituitary Macroadenomas
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