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Clinical Trial NCT06122610 for Neuroendocrine Tumors, Somatostatin Receptor-positive Neuroendocrine Tumor is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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University of Wisconsin, MadisonUsing Novel Imaging to More Safely Treat Neuroendocrine Tumors
Clinical Trial NCT06122610 is designed to study Treatment for Neuroendocrine Tumors, Somatostatin Receptor-positive Neuroendocrine Tumor. It is a Phase 1 interventional trial that is recruiting, having started on 7 March 2025, with plans to enroll 10 participants. Led by University of Wisconsin, Madison, it is expected to complete by 1 February 2026. The latest data from ClinicalTrials.gov was last updated on 13 May 2025.
Brief Summary
The goal of this research is to determine if DetectnetTM PET/CT can be used to make Lutathera therapy safer for patients with neuroendocrine cancer.
Participants will:
- Complete two phases involving 6 visits
- Undergo additional research PET/CT, and possibly SPECT/CT scans
Detailed Description
The goal of this research study is to determine if DetectnetTM PET/CT scanning over several days can be used to deliver Lutathera in a safer manner.
In this research, participants will be asked to complete a screening phase and possibly a dosimetry phase. The screening phase will require 2 visits. The dosimetry phase will also require 3 research visits.
Official Title
Dosimetry-Guided 177Lu-DOTATATE Treatment Planning Using 64Cu-DOTATATE as a Surrogate
Conditions
Neuroendocrine TumorsSomatostatin Receptor-positive Neuroendocrine TumorOther Study IDs
- 2023-0121
- Protocol Version 3/24/2025 (Other Identifier) (UW Madison)
- SMPH/RADIOLOGY/RADIOLOGY (Other Identifier) (UW Madison)
NCT ID Number
Start Date (Actual)
2025-03-07
Last Update Posted
2025-05-13
Completion Date (Estimated)
2026-02
Enrollment (Estimated)
10
Study Type
Interventional
PHASE
Phase 1
Status
Recruiting
Keywords
neuroendocrine tumors
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalParticipants treated with Lutathera | Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT) SPECT/CT will be performed after first cycle of Lutathera® treatment Photon Emission Tomography / CT (PET/CT) PET/CT will be performed after 64Cu-DOTATATE and Lutathera® treatment 64Cu-Dotatate Standard of care administration of radioactive drug for PET/CT 177Lu-Dotatate Standard of care administration of radioactive drug for PET/CT and SPECT/CT |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Compare pre-therapy and post-therapy voxel-based dosimetry estimates | Absorbed doses to organs will be estimated using radiation dosimetry methods based on both multi-timepoint PET and multi-timepoint SPECT imaging. Mean dose estimates in units of Gy to the index tumor(s) and dose limiting organs (kidneys and bone marrow) will be compared between PET-based dosimetry and SPECT-based dosimetry. Using SPECT-based dosimetry as the gold standard truth, Bland-Altman analysis will be performed for each organ/tumor to compare PET-based dose estimates to SPECT-based estimates. Mean bias and 95% confidence intervals will be calculated. | Baseline and 120 hours post-dose |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Absorbed radiation doses | Absorbed radiation doses from 177Lu-DOTATATE in organs will be summarized with descriptive statistics. | 1 hour post-dose, 4 hours post-dose, 48 hours post-dose, 120 hours post-dose |
Absorbed radiation doses of 64Cu-DOTATATE | Absorbed radiation doses of 177Lu-DOTATATE in organs using 64Cu-DOTATATE as an imagining surrogate will be summarized with descriptive statistics. | 1 hour post-dose, 4 hours post-dose, 48 hours post-dose, 120 hours post-dose |
Compare 3D voxel-based versus model based dosimetry in participants receiving 177Lu_DOTATATE | Absorbed doses to organs will be estimated using radiation dosimetry methods based on multi-timepoint SPECT imaging. Mean dose estimates in units of Gy to the index tumor(s) and dose limiting organs (kidneys and bone marrow) will be compared between 3D voxel-based and model-based dosimetry methods. Using 3D voxel-based dosimetry as the gold standard truth, Bland-Altman analysis will be performed for each organ/tumor to compare 3D voxel-based to model-based methods. Mean bias and 95% confidence intervals will be calculated. | Baseline and 120 hours post-dose |
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- Candidates for 177Lu-DOTATATE (Lutathera) treatment for somatostatin receptor-positive neuroendocrine tumor
- Unable to lie flat during or tolerate PET/CT or SPECT/CT
- Known incompatibility to CT. SPECT, or PET scans
- Unlikely to comply with study procedures, restrictions and requirements and judged by the investigator that the participant is not suitable for participation in the study
University of Wisconsin, Madison247 active trials to exploreStudy Central Contact
Contact: Radiology Studies, 608-282-8349, [email protected]
1 Study Locations in 1 Countries
Wisconsin
University of Wisconsin - Madison, Madison, Wisconsin, 53705, United States
Recruiting