Overview
Multicenter Evaluation of the Effect of Upfront Radiosurgery on Residual Growth Hormone-secreting Pituitary Adenoma
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2022-12-31
2022-12-31
Target enrollment:
0
0
Participant gender:
All
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 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Samsung Medical CenterTreatments:
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