Using Novel Imaging to More Safely Treat Neuroendocrine Tumors

Study Overview
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Brief Summary
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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
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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
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Dosimetry-Guided 177Lu-DOTATATE Treatment Planning Using 64Cu-DOTATATE as a Surrogate

Conditions
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Neuroendocrine Tumors, Somatostatin Receptor-positive Neuroendocrine Tumor

Intervention / Treatment
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* Device: Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT)
* Device: Photon Emission Tomography / CT (PET/CT)
* Drug: 64Cu-Dotatate
* Drug: 177Lu-Dotatate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants treated with Lutathera<br> | Device: Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT)<br>* SPECT/CT will be performed after first cycle of Lutathera® treatment<br>Device: Photon Emission Tomography / CT (PET/CT)<br>* PET/CT will be performed after 64Cu-DOTATATE and Lutathera® treatment<br>Drug: 64Cu-Dotatate<br>* Standard of care administration of radioactive drug for PET/CT<br>* Other names: Detectnet;Drug: 177Lu-Dotatate<br>* Standard of care administration of radioactive drug for PET/CT and SPECT/CT<br>* Other names: Lutathera®;|

What is the study measuring?
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Primary 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 96 hours post-dose | 

Secondary Outcome Measures

| 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, 96 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, 96 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 96 hours post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neuroendocrine tumors