Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06395402 · ClinicalTrials.gov registry record · Phase 2
177Lu-DOTATATE Modified Delivery Based on Individualized Dosimetry
A Phase 2 study of Neuroendocrine Tumors and Neuroendocrine Tumor Grade 2, sponsored by University of Iowa.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT06395402: Recruiting Phase 2 study of Neuroendocrine Tumors and Neuroendocrine Tumor Grade 2, sponsored by University of Iowa.
NCT06395402 is a Phase 2 study of Neuroendocrine Tumors and Neuroendocrine Tumor Grade 2 that is actively recruiting participants, run by University of Iowa. The registered enrollment target is 120 participants, below the 177-participant average among 52 other Neuroendocrine Tumors trials with a reported enrollment target (32% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06395402, a Phase 2 study of Neuroendocrine Tumors and Neuroendocrine Tumor Grade 2, is actively recruiting participants, sponsored by University of Iowa.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this study is to learn if individualized dosimetry-based prescribing of Lutetium-177 DOTATATE (Lutathera, Novartis Pharmaceuticals) improves treatment outcomes for adults with unresectable neuroendocrine tumors. To investigate this, study participants will: * Undergo Somatostatin Receptor (SSTR) positron emission tomography (PET) imaging, such as a DOTATOC PET/CT scan * Be randomized to receive standard treatment (as per FDA guidelines) or investigational treatment (customized dosing of Lutathera based upon dosimetry) * Undergo blood tests for 4 to 8 weeks after each Lutathera treatment * Complete patient reported outcome questionnaires * Visit the clinic for follow-up about every 8 weeks.
Primary Outcome
Determine objective response rate in patients with grade 1 or 2 gastroenteropancreatic neuroendocrine tumors (GEP-NET) treated with dosimetrically-determined LUTATHERA administration compared to active control.
Conditions Studied
Interventions
- DRUG Lutetium Lu 177 dotatate therapy
Study Locations (1)
Iowa
- Holden Comprehensive Cancer Center at the University of Iowa - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2024-05-03 |
| Est. Completion | 2029-12-31 |
| Phase | Phase 2 |
What NCT06395402 shows while recruiting
NCT06395402 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 177-participant average among 52 other Neuroendocrine Tumors trials with a reported enrollment target (32% lower).
The record links to 3 conditions, with Neuroendocrine Tumors appearing as the primary indexed condition, and to 1 intervention - of which Lutetium Lu 177 dotatate therapy is the first listed.
NCT06395402 reports a single indexed study location in Iowa.
Frequently Asked Questions
What is clinical trial NCT06395402 about?
NCT06395402 is a clinical study titled "177Lu-DOTATATE Modified Delivery Based on Individualized Dosimetry". The goal of this study is to learn if individualized dosimetry-based prescribing of Lutetium-177 DOTATATE (Lutathera, Novartis Pharmaceuticals) improves treatment outcomes for adults with unresectable neuroendocrine tumors. To investigate this, study participants will: * Undergo Somatostatin Recept...
What is the current status of trial NCT06395402?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2024-05-03. Estimated completion is 2029-12-31.
What conditions does trial NCT06395402 study?
This clinical trial studies the following conditions: Neuroendocrine Tumors, Neuroendocrine Tumor Grade 2, Neuroendocrine Tumor Grade 1.
What interventions are being tested in trial NCT06395402?
The interventions under investigation include: Lutetium Lu 177 dotatate therapy (DRUG).
Who is sponsoring clinical trial NCT06395402?
This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06395402 being conducted?
This trial has 1 study location across Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Neuroendocrine Tumors
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 NCT06395402's enrollment target sits among peer trials
120 19th of 52 higher than 33 of 52 other Neuroendocrine Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neuroendocrine Tumors 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
-
Lenvatinib Plus Pembrolizumab in Well Differentiated G3 Neuroendocrine Tumors
RECRUITING · Phase 2
-
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer
RECRUITING · Phase 2
-
Trial of Nab-sirolimus in Patients With Well-differentiated Neuroendocrine Tumors (NETs) of the Gastrointestinal Tract, Lung, or Pancreas Who Have Not Received Prior Treatment With mTOR Inhibitors
RECRUITING · Phase 2
-
Lu-177-DOTATATE (Lutathera) in Therapy of Inoperable Pheochromocytoma/ Paraganglioma
RECRUITING · Phase 2
-
Adoptive Transfer of Tumor Infiltrating Lymphocytes for Advanced Solid Cancers
RECRUITING · Phase 2
-
Trial of an Alternative Cabozantinib Dosing Schedule in Metastatic Renal Cell Carcinoma and Neuroendocrine Tumors
RECRUITING · Phase 2
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
- NCT01174108 · 120 participants · Phase 2
Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells
- NCT01627301 · 120 participants · NA
Sympathetic Overactivity in Post-traumatic Stress Disorder
- NCT02025023 · 120 participants · Phase 3
Local 5-Fluorouracil Injection for the Treatment of Chalazia: A Prospective, Comparative Study
- NCT02128906 · 120 participants · Phase 2
Radiotherapy With Cisplatin vs. Docetaxel-cetuximab in HNSCC: ERCC1 Biomarker Enrichment and Interaction Design
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI