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NCT01861717 · ClinicalTrials.gov registry record · Phase 4
A Pilot Study of Pre- and Post-operative Use of Somatuline Depot.
A Phase 4 study, sponsored by Saint John's Cancer Institute.
- Terminated
- Registry status
- Phase 4
- Development phase
- 4
- Enrollment target
NCT01861717: Clinical Trial Phase 4 study, sponsored by Saint John's Cancer Institute.
NCT01861717 is a Phase 4 study that was terminated before completion, run by Saint John's Cancer Institute. The registered enrollment target is 4 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01861717, a Phase 4 study, was terminated before completion, sponsored by Saint John's Cancer Institute.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 4 participants
- Enrollment target
Study Summary
If someone is diagnosed with a pituitary tumor that causes acromegaly (too much growth hormone) the treatment is to have it surgically removed. This study has two phases. The first phase provides medical treatment with a drug that will be provided for 3 months before surgery to see if complications of surgery are reduced and to see whether or not remission improves following surgery if you have this medical treatment. The drug administered is approved by the FDA for long-term treatment of acromegaly. It is not routinely administered before surgery, and is therefore experimental as used in this way. All other procedures performed during this research are standard of care with the exception of the 3 questionnaires to be completed at each visit. The second phase of this study is from 3 months until 12 months after surgery and is only for people who do not go into remission after the operation. This phase assesses the possible remission of acromegaly after resuming the drug treatment for an additional 3 to 9 months. The drug will be prescribed by your physician as part of your regular medical care and will not be included as part of the study. All other procedures performed during this research are standard of care with the exception of the 3 questionnaires to be completed at each visit. The study lasts approximately 16 months - 3 month before surgery and 12 months after surgery.
Primary Outcome
Early remission status after a 12 week course of pre-operative Somatuline Depot and 3 months after endonasal endoscopic surgery. Remission status will be based on age-adjusted Insulin Glucose Factor 1 (IGF-1) levels and oral glucose tolerance test.
Interventions
- DRUG lanreotide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2013-05 |
| Est. Completion | 2016-01 |
| Phase | Phase 4 |
Why NCT01861717 stopped before completion
NCT01861717 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which lanreotide is the first listed.
NCT01861717 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01861717 about?
NCT01861717 is a clinical study titled "A Pilot Study of Pre- and Post-operative Use of Somatuline Depot.". If someone is diagnosed with a pituitary tumor that causes acromegaly (too much growth hormone) the treatment is to have it surgically removed. This study has two phases. The first phase provides medical treatment with a drug that will be provided for 3 months before surgery to see if complications...
What is the current status of trial NCT01861717?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 4 participants. The study started on 2013-05. Estimated completion is 2016-01.
What interventions are being tested in trial NCT01861717?
The interventions under investigation include: lanreotide (DRUG).
Who is sponsoring clinical trial NCT01861717?
This trial is sponsored by Saint John's Cancer Institute, which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01861717's enrollment target sits among peer trials
4 1994th of 2000 higher than 6 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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
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