Radioactive Iodine Implants for Pan-invasive Pituitary Macroadenomas



Status:Recruiting
Healthy:No
Age Range:18 - 99
Updated:1/6/2019
Start Date:September 30, 2011
End Date:December 2021
Contact:Robert Timmerman, MD
Phone:214-645-8525

Use our guide to learn which trials are right for you!

Interstitial Radioactive Iodine Implants for the Treatment of Pan-invasive Pituitary Macroadenomas

This study is a single arm Phase II pilot trial. Patients enrolled on the trial will undergo
implantation of high activity iodine-125 seeds into their pituitary adenoma. The tumor
response to treatment will be monitored as well as change in visual fields, associated
adverse effects, progression free survival and patient reported outcomes.


Inclusion Criteria:

- Pathological or radiographic diagnosis of a pan-invasive pituitary macroadenoma

- Pan-invasive for the purposes of the protocol will be defined as meeting each of the
following 2 major criteria: (1). tumor volume greater than 20 cc at enrollment, and
(2). suprasellar extension. In addition, a pan-invasive tumor must meet any one of the
following 3 minor criteria, a) unresectable tumor invasion into a cavernous sinus, b)
bone or bone marrow invasion into the clivus or temporal bones, or c) tumor extension
in any direction unlikely to be completely removed by specifically a transphenoidal
surgical approach.

- Patients who meet the two major criteria above (1 and 2) and are medically inoperable
for tumor resection (due to confounding co-existing medical problems) are eligible
without meeting any of the three minor criteria (a, b, or c).

- Patients should be immediately threatened for vision loss or other significant
neurological impairment directly related to tumor mass effect. As such, all patients
enrolled would likely benefit from tumor response (shrinkage).

- Patients must have visible tumor on imaging studies (MRI or CT)

- The patient's Zubrod performance status must be 0-3.

- Patients must be at least 18 years of age.

- Mandatory Imaging Studies: Must be done 45 or fewer days prior to :

MRI or CT scan of the brain including the entire skull base and all areas of tumor
extension

Exclusion Criteria:

- Patients who are unable to undergo general anesthesia

- Patients who are unable to undergo placement of a stereotactic head frame

- Patients who are unable to provide informed consent

- Patients who are pregnant or nursing

- Patients with severe kidney dysfunction

- Patients who have contraindications to MRI, such as implanted pacemaker device

- Patients with diagnosis of pituitary carcinoma
We found this trial at
1
site
1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Principal Investigator: Robert Timmerman, MD
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
?
mi
from
Dallas, TX
Click here to add this to my saved trials