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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06395402
The ClinicalTrials.gov registry entry for NCT06395402 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 177-participant average among 52 other Neuroendocrine Tumors trials with a reported enrollment target (32% lower). The listed sponsor is University of Iowa, which has 228 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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