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Characterization of Receptors Present in Non-functioning Pituitary Macroadenomas by Reverse Transcriptase- Polymerase Chain Reaction (RT-PCR)

Phase 4
18 Years
Open (Enrolling)
Pituitary Tumor

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Trial Information

Characterization of Receptors Present in Non-functioning Pituitary Macroadenomas by Reverse Transcriptase- Polymerase Chain Reaction (RT-PCR)

The pituitary gland in the brain is the master hormonal gland and is surrounded by important
nerves and blood vessels. The pituitary gland can develop various types of tumors, some
which do not produce any hormones and are called non-functioning pituitary adenomas. These
non-functioning tumors can grow and can cause compression of these important structures. The
usual treatment of large non-functioning pituitary macroadenoma is surgery. As it is
surrounded by neuro-vascular bundles, this makes complete removal of the tumor sometimes
impossible and even dangerous. A large number of subjects will still have some residual
tumor post-surgery. The risks of residual tumor are further growth with compression and
compromise of the function of surrounding vital organs especially vision.

If there is further growth of the tumor the options at present are repeat surgery or
radiotherapy. Repeat surgery involves all the risks associated with brain surgery and
sometimes may not be possible if very close to vital organs, while radiotherapy will over a
period of time lead to complete or partial deficiency of pituitary hormone function and has
been associated with long term cognitive deficits. In addition radiotherapy has a lag time
of 12-24 months prior to onset of action.

However, pituitary tumors that do not actively secrete hormones may still harbour receptors
to various hormones. The blockage of these receptors by various medications may enable us to
stop the tumor from growing or recurring after surgery. This may open up a novel means of
treatment of these non functioning tumors. So far there is very little information in the
literature about the type of receptors present in these tumors.

Our study proposes to obtain a piece of the tissue removed during surgery and perform
receptor characterization to help improve our knowledge in that area. Also correlating the
receptor status with the clinical, hormonal and radiological profile of the patients may
help to develop improved treatment strategies in the future and help us to predict the
possibility of tumor regrowth.

Inclusion Criteria:

1. Adults, both males and females age 18 years old or more

2. Pituitary tumor more than 10 mm in diameter diagnosed by MRI

3. No clinical or laboratory evidence of pituitary hormone oversecretion
(non-functioning pituitary macroadenoma)

Exclusion Criteria:

1. Subjects with pituitary tumors less than 10 mm in diameter

2. Subjects with clinical or laboratory evidence of hormone oversecretion

3. Presence of dementia

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

To determine the expression of hormonal receptors in clinically non-functioning pituitary macroadenomas by RT - PCR and immunohistochemistry.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Ambika Babu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

John H Stroger Jr. Hospital of Cook County


United States: Institutional Review Board

Study ID:




Start Date:

March 2006

Completion Date:

December 2013

Related Keywords:

  • Pituitary Tumor
  • Non-functioning pituitary adenoma
  • Hormonal receptors
  • Pituitary Neoplasms



John H Stroger Jr. Hospital of Cook County Chicago, Illinois  60612