Utilization of iMRI for Transsphenoidal Resection of Pituitary Macroadenomas

NCT ID: NCT02396810

Last Updated: 2023-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-19

Study Completion Date

2023-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Pituitary Macroadenoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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No intra-operative MRI

Patients undergo transsphenoidal surgery without an intra-operative MRI.

Group Type PLACEBO_COMPARATOR

Transsphenoidal resection of pituitary macroadenoma

Intervention Type PROCEDURE

Routine transsphenoidal resection of pituitary macro adenomas

intra-operative MRI

Patients undergo transspheonidal surgery followed by intra-operative MRI.

Group Type EXPERIMENTAL

intra-operative MRI

Intervention Type OTHER

Intra-operative magnetic resonance imaging under general anesthesia

Transsphenoidal resection of pituitary macroadenoma

Intervention Type PROCEDURE

Routine transsphenoidal resection of pituitary macro adenomas

Interventions

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intra-operative MRI

Intra-operative magnetic resonance imaging under general anesthesia

Intervention Type OTHER

Transsphenoidal resection of pituitary macroadenoma

Routine transsphenoidal resection of pituitary macro adenomas

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Nathan E. Simmons

Staff Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00028376 D14236

Identifier Type: -

Identifier Source: org_study_id

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