Neuroendocrine Tumors, Somatostatin Receptor-positive Neuroendocrine Tumor
Conditions
Keywords
neuroendocrine tumors
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.
Interventions
SPECT/CT will be performed after first cycle of Lutathera® treatment
DEVICEPhoton Emission Tomography / CT (PET/CT)
PET/CT will be performed after 64Cu-DOTATATE and Lutathera® treatment
DRUG64Cu-Dotatate
Standard of care administration of radioactive drug for PET/CT
DRUG177Lu-Dotatate
Standard of care administration of radioactive drug for PET/CT and SPECT/CT
Sponsors
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Candidates for 177Lu-DOTATATE (Lutathera) treatment for somatostatin receptor-positive neuroendocrine tumor
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTRadiology Studies
PRINCIPAL_INVESTIGATORChanghee Lee, MD
University of Wisconsin, Madison
Outcome results
None listed