Prospective Study of Clinically Nonfunctioning Pituitary Adenomas
Prospective Study of Clinically Nonfunctioning Pituitary Adenomas
This project is the first comprehensive prospective study of clinically non-functioning
 pituitary adenomas (CNFAs). Two groups of subjects will be studied: Group I will consist of
 100 patients with clinically non-functioning (CNF) pituitary lesions who are asymptomatic and
 do not require surgery; Group II will consist of 250 patients who have pituitary lesions that
 are symptomatic and require surgery. Patients will be followed with a series of endocrine
 laboratory testing, physical examinations, testing of quality of life and neurocognitive
 function before and serially over time either during non-surgical management or after surgery
 and in some patients before and after radiotherapy (RT). Data on pituitary magnetic resonance
 imaging (MRI) studies and visual field testing being done over time during follow up as part
 of clinical care will be collected.
PROTOCOL I: Prospective Study of the outcome of conservative non-surgical management of
 patients with asymptomatic, clinically non-functioning (CNF) pituitary lesions. This protocol
 will evaluate prospectively the outcome of non-surgical management of clinically
 non-functioning pituitary lesions that do not appear to need surgery as their initial
 therapy. The overall design consists of an initial baseline evaluation and then serial
 prospective follow up studies over time for up to 5 years of follow up. The study will
 evaluate laboratory testing, clinical examinations, quality of life and neurocognitive
 function in these patients. Data will be collected on visual fields and MRI studies of the
 pituitary tumor that are done prospectively as part of clinical care to evaluate these
 patients.

 PROTOCOL II : Prospective study of the outcome of patients with symptomatic, clinically
 non-functioning pituitary tumors who are treated with transsphenoidal surgery and in some
 cases also radiotherapy. This protocol will evaluate prospectively the outcome of surgical
 management of asymptomatic clinically nonfunctioning pituitary lesions. The overall design
 consists of an initial baseline evaluation and then serial prospective follow up studies over
 time with up to 5 years of follow up. The study will evaluate laboratory testing, clinical
 examinations, quality of life and neurocognitive function in these patients. Data will also
 be collected on visual fields and MRI studies of the pituitary tumor that are done
 prospectively as part of clinical care to evaluate these patients. Data will be analyzed to
 determine the safety of observation alone following surgery for patients who do not have a
 clinically significant tumor remnant, if the silent corticotroph tumor type is characterized
 by elevated plasma levels of ACTH or its precursor, POMC, and if it is associated with an
 increased tumor recurrence rate. A group of patients who are planning RT will also be studied
 by these same procedures before and after RT in order to determine if the outcomes of
 patients who receive RT for treatment of tumor re-growth to that of those who do not receive
 RT with respect to further tumor growth, endocrine or neurological dysfunction. Quality of
 life and neurocognitive function in patients with clinically non-functioning pituitary
 lesions treated with surgery alone or those who also receive radiotherapy will be
 prospectively assessed.
GROUP I

 Inclusion Criteria:

 -  adult patients with pituitary lesions that do not require surgical intervention.

 -  pituitary lesion that has been demonstrated on a magnetic resonance imaging (MRI) to
 be consistent with an adenoma (not a cystic lesion such as a Rathke's cleft cyst).

 -  patients with macroadenomas (> 1 cm) or large microadenomas 6-9 mm.

 -  a prolactin level < 40 ng/ml.

 Exclusion Criteria:

 -  presence of visual or neurological deficits due to the tumor, tumor impingement on the
 optic chiasm and physical or laboratory abnormalities consistent with a biologically
 active hormone secreting tumor.

 GROUP II

 Inclusion Criteria:

 -  adult patients with pituitary lesions that require surgical intervention and are
 planning on surgery or who had surgery in the past and are now undergoing pituitary
 radiotherapy.

 -  pre-surgery patients will have a pituitary lesion that has been demonstrated on a MRI
 to be consistent with an adenoma (not a cystic lesion such as a Rathke's cleft cyst)
 and that is a macroadenoma (> 1 cm).

 -  presence of visual or neurological deficits due to the tumor or impingement of the
 tumor on the optic chiasm is permitted.

 -  a prolactin level < 100 ng/ml if lesion is > or = 10 mm in size or a prolactin level <
 40 ng/ml if lesion is < 10 mm in size.

 -  patients with mild/moderate hyperprolactinemia and recommended for dopamine agonist
 therapy (on the chance that the lesion is truly a prolactinoma) may re-enter the study
 should they be a dopamine agonist failure and require surgery.

 -  patients with hypopituitarism and no other surgical indication that choose to undergo
 surgery is permitted.