Overview

Multicenter Evaluation of the Effect of Upfront Radiosurgery on Residual Growth Hormone-secreting Pituitary Adenoma

Status:
Not yet recruiting
Trial end date:
2022-12-31
Target enrollment:
0
Participant gender:
All
Summary
In this study, the investigators hypothesize that upfront gamma knife radiosurgery with drug therapy is superior in the treatment of growth hormone-secreting pituitary tumors after primary surgical treatment compared with the drug therapy alone. This study can provide useful clinical information in the treatment of patients with acromegaly.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Samsung Medical Center
Treatments:
Angiopeptin
Hormones
Lanreotide
Somatostatin
Criteria
Inclusion Criteria:

- Among patients with acromegaly due to growth hormone secreting pituitary adenoma who
underwent primary surgical resection, patients who fail to achieve endocrinologic
remission at 3 months after surgery.

- On brain MRI scan at 3months after surgery, residual tumor is confirmed by clinicians

- the definition of endocrinologic remission

1. random growth hormone level < 2.5 ug/L

2. normalization of age-matched insulin growth factor-1 level

Exclusion Criteria:

- patients with contraindication of stereotactic radiosurgery; e.g. pregnancy or
planning pregnancy, or claustrophobia

- recurrent pituitary adenoma

- limited life expectancy due to systemic disease; e.g. malignant tumor, genetic
disease, and terminal stage of renal or hepatic failure

- disability to clinic visit due to postoperative complications