Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01371643 · ClinicalTrials.gov registry record · Phase 4
Surgical Debulking of Pituitary Adenomas
A Phase 4 study of Pituitary Adenoma, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 4
- Development phase
- 41
- Enrollment target
- 1
- Study location
NCT01371643: Completed Phase 4 study of Pituitary Adenoma, sponsored by NYU Langone Health.
NCT01371643 is a Phase 4 study of Pituitary Adenoma that has completed, run by NYU Langone Health. The registered enrollment target is 41 participants, below the 284-participant average among 9 other Pituitary Adenoma trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01371643, a Phase 4 study of Pituitary Adenoma, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 41 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a randomized, multicenter trial with stratification done by a single radiologist at the coordinating center (NYU), and patients with comparable disease will be randomized to Sandostatin LAR treatment administered 1 time per month by IM injection for 3 months before (Arm A) or, for non-cured patients, after (Arm B) surgery. All patients will undergo transsphenoidal hypophysectomy. The impact of surgical debulking on responsiveness to Sandostatin LAR will be evaluated.The primary objective of this trial will be to determine whether surgery (debulking of pituitary adenomas) improves the response of patients with acromegaly to treatment with Octreotide LAR, when compared to Octreotide LAR therapy alone.
Primary Outcome
Nadir growth hormone \<1 ng/mL during a standard 2 hour oral glucose tolerance test using 75 g glucose and normal IGF-I according to age and gender-matched standards.
Conditions Studied
Interventions
- DRUG Octreotide LAR
- PROCEDURE transsphenoidal surgery
Study Locations (1)
New York
- New York University School of Medicine - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2004-04 |
| Est. Completion | 2011-12 |
| Phase | Phase 4 |
What the finished NCT01371643 record still lists
NCT01371643 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 284-participant average among 9 other Pituitary Adenoma trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Pituitary Adenoma appearing as the primary indexed condition, and to 2 interventions - of which Octreotide LAR is the first listed.
NCT01371643 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01371643 about?
NCT01371643 is a clinical study titled "Surgical Debulking of Pituitary Adenomas". This is a randomized, multicenter trial with stratification done by a single radiologist at the coordinating center (NYU), and patients with comparable disease will be randomized to Sandostatin LAR treatment administered 1 time per month by IM injection for 3 months before (Arm A) or, for non-cured ...
What is the current status of trial NCT01371643?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 41 participants. The study started on 2004-04. Estimated completion is 2011-12.
What conditions does trial NCT01371643 study?
This clinical trial studies the following conditions: Pituitary Adenoma.
What interventions are being tested in trial NCT01371643?
The interventions under investigation include: Octreotide LAR (DRUG), transsphenoidal surgery (PROCEDURE).
Who is sponsoring clinical trial NCT01371643?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01371643 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pituitary Adenoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01371643's enrollment target sits among peer trials
41 7th of 9 higher than 3 of 9 other Pituitary Adenoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pituitary Adenoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Prophylactic Oral Antibiotics on Sinonasal Outcomes Following Endoscopic Transsphenoidal Surgery for Pituitary Lesions
RECRUITING · Phase 4
-
68-Ga DOTATATE PET/MRI in the Diagnosis and Management of Somatostatin Receptor Positive CNS Tumors.
RECRUITING · Phase 4
-
Evaluation of Intraoperative Contrast Enhanced Ultrasound for the Identification of Pituitary Adenoma in Cushing's Disease Compared to Other Pituitary Tumors
RECRUITING
-
DDAVP for Pituitary Adenoma
RECRUITING · NA
-
Use of [18F] Fluoroethyl-L-tyrosine PET/MRI for Identifying Small Functional Pituitary Adenomas
RECRUITING · Phase 1
-
A First in Human Study Using 89Zr-cRGDY Ultrasmall Silica Particle Tracers for Malignant Brain Tumors
ACTIVE NOT RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03449238 · 41 participants · Phase 1
Pembrolizumab And Stereotactic Radiosurgery (Srs) Of Selected Brain Metastases In Breast Cancer Patients
- NCT03900793 · 41 participants · Phase 1
Losartan + Sunitinib in Treatment of Osteosarcoma
- NCT04082520 · 41 participants · Phase 2
Lutathera for the Treatment of Inoperable, Progressive Meningioma After External Beam Radiation Therapy
- NCT04220190 · 41 participants · Phase 2
RAPA-501 Therapy for ALS
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia