Utilization of iMRI for Transsphenoidal Resection of Pituitary Macroadenomas

August 7, 2023 updated by: Nathan E. Simmons, Dartmouth-Hitchcock Medical Center

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03765
        • Dartmouth Hitchcock Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults 18-90
  • Capable of giving informed consent
  • Elect for transsphenoidal surgery

  • Has pre-operative MRI demonstrating pituitary tumor that is:

    1. deemed resectable using a transsphenoidal approach and
    2. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: No intra-operative MRI
Patients undergo transsphenoidal surgery without an intra-operative MRI.
Procedure: Transsphenoidal resection of pituitary macroadenoma
Routine transsphenoidal resection of pituitary macro adenomas
Experimental: intra-operative MRI
Patients undergo transspheonidal surgery followed by intra-operative MRI.
Procedure: Transsphenoidal resection of pituitary macroadenoma
Routine transsphenoidal resection of pituitary macro adenomas
Other: intra-operative MRI
Intra-operative magnetic resonance imaging under general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time
Time Frame: intraoperative
Length of operation
intraoperative
Frequency of post-operative CSF leak
Time Frame: 30 days post surgery
Frequency of post-operative Cerebrospinal Fluid (CSF) leak
30 days post surgery
Rate of Readmission
Time Frame: 30 days post surgery
Frequency of readmission
30 days post surgery
Length of anesthesia time
Time Frame: intraoperative
Length of time participant is under anesthesia
intraoperative
Rate of post-operative endocrinopathies
Time Frame: 30 days post surgery
Rate of post-operative endocrinopathies
30 days post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2015

Primary Completion (Actual)

July 1, 2023

Study Completion (Actual)

July 1, 2023

Study Registration Dates

First Submitted

March 5, 2015

First Submitted That Met QC Criteria

March 23, 2015

First Posted (Estimated)

March 24, 2015

Study Record Updates

Last Update Posted (Actual)

August 8, 2023

Last Update Submitted That Met QC Criteria

August 7, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00028376 D14236

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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