An observational study in Neuroendocrine Tumors, sponsored by Advanced Accelerator Applications. Active, not recruiting at 20 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-23.
Sponsored by Advanced Accelerator Applications (part of Novartis) · Observational
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Among 18 studies in Neuroendocrine Tumors by Novartis — none open to participants now, 1 under way, none of them phase 3. Neuroendocrine Tumors · Novartis.
Among the 18 studies in Neuroendocrine Tumors by Novartis, this one is the only one that started in 2018, is one of 4 observational ones, and was the 14th registered.
542 studies on the registry are indexed under Neuroendocrine Tumors; 135 are open to participants now.
Browse Neuroendocrine Tumors studies →None of the 18 studies in Neuroendocrine Tumors by Novartis is open now. The open studies under Neuroendocrine Tumors, anywhere →
Of the 112 Neuroendocrine Tumors studies recruiting now, 73 (65%) set no upper age limit and 17 (15%) stop at 75 or younger; 12 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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18 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 1,014 is above the median of 130 across 129 observational studies indexed under Neuroendocrine Tumors.
Median enrollment 62 across the 13 interventional studies, 141 across the 4 observational. Of the 16 that completed or were terminated, 10 (63%) have results posted.
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This study is registered under Advanced Accelerator Applications, one of the names counted as Novartis. Under that name alone:
Advanced Accelerator Applications is the lead sponsor of 17 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 4 (67%) have results posted.
1 of the studies in Neuroendocrine Tumors by Novartis that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03691064Advanced Accelerator ApplicationsPost-Authorization Long-Term Safety Study of LUTATHERA | 2027-09-30 |
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Among the 18 studies in Neuroendocrine Tumors by Novartis, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Study to assess the long-term safety of LUTATHERA for the labeled indication (SmPC/USPI).
To assess the incidence and nature of potential long-term safety outcomes in patients with unresectable or metastatic, well-differentiated, somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours. Retrospective and prospective data will be used.
Adult patients treated with LUTATHERA for the labeled indication using the approved dosing regimen.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treated per labeled LUTATHERA dosing regimen.
Drug: LUTATHERA
Labeled dosing regimen: 7.4 gigaBecquerel (GBq) (200 milliCurie \[mCi\]) every 8 weeks for a total of 4 doses.
Also known as: Lu 177 dotatate
secondary cancers: incidence of secondary cancers
incidence of secondary cancers
Time frame: up to 7 years follow-up
safety profile: incidence of adverse events
incidence of adverse events
Time frame: up to 7 years follow-up
mortality
mortality (all cause)
Time frame: up to 7 years follow-up
LUTATHERA dose per administration
average dose per administration
Time frame: completion of treatment phase (approximately 2 years total)
LUTATHERA total dose
average total dose administered
Time frame: completion of treatment phase (approximately 2 years total)
LUTATHERA number of administrations
average number of LUTATHERA doses
Time frame: completion of treatment phase (approximately 2 years total)
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2018 (actual). Primary completion is estimated for Sep 2027, 106 months after the start.
Of 54 observational studies under Neuroendocrine Tumors, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 239. This study's planned 106 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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