Utilization of iMRI for Transsphenoidal Resection of Pituitary Macroadenomas

Dartmouth Health

Status: Terminated

Conditions: Pituitary Macroadenoma

Treatments: Other: intra-operative MRI; Procedure: Transsphenoidal resection of pituitary macroadenoma

Study type: Interventional

Funder types: Other

Identifiers

NCT02396810

STUDY00028376 D14236

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 2 patient groups, including a placebo group

No intra-operative MRI

Placebo Comparator group

Description:

Patients undergo transsphenoidal surgery without an intra-operative MRI.

Treatment:

Procedure: Transsphenoidal resection of pituitary macroadenoma

intra-operative MRI

Experimental group

Description:

Patients undergo transspheonidal surgery followed by intra-operative MRI.

Treatment:

Procedure: Transsphenoidal resection of pituitary macroadenoma

Other: intra-operative MRI