Using Novel Imaging to More Safely Treat Neuroendocrine Tumors
- Conditions
- Somatostatin Receptor-positive Neuroendocrine TumorNeuroendocrine Tumors
- Interventions
- Device: Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT)Device: Photon Emission Tomography / CT (PET/CT)
- Registration Number
- NCT06122610
- Lead Sponsor
- University of Wisconsin, Madison
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Participants treated with Lutathera Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT) - Participants treated with Lutathera Photon Emission Tomography / CT (PET/CT) - Participants treated with Lutathera 64Cu-Dotatate - Participants treated with Lutathera 177Lu-Dotatate -
- Primary Outcome Measures
Name Time Method Compare pre-therapy and post-therapy voxel-based dosimetry estimates Baseline and 120 hours post-dose 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.
- Secondary Outcome Measures
Name Time Method Absorbed radiation doses 1 hour post-dose, 4 hours post-dose, 48 hours post-dose, 120 hours post-dose Absorbed radiation doses from 177Lu-DOTATATE in organs will be summarized with descriptive statistics.
Absorbed radiation doses of 64Cu-DOTATATE 1 hour post-dose, 4 hours post-dose, 48 hours post-dose, 120 hours post-dose Absorbed radiation doses of 177Lu-DOTATATE in organs using 64Cu-DOTATATE as an imagining surrogate will be summarized with descriptive statistics.
Compare 3D voxel-based versus model based dosimetry in participants receiving 177Lu_DOTATATE Baseline and 120 hours post-dose 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.
Trial Locations
- Locations (1)
University of Wisconsin - Madison
🇺🇸Madison, Wisconsin, United States