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Trial Title:
Using Novel Imaging to More Safely Treat Neuroendocrine Tumors
NCT ID:
NCT06122610
Condition:
Neuroendocrine Tumors
Somatostatin Receptor-positive Neuroendocrine Tumor
Conditions: Official terms:
Neoplasms
Neuroendocrine Tumors
Lutetium Lu 177 dotatate
Conditions: Keywords:
neuroendocrine tumors
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT)
Description:
SPECT/CT will be performed after first cycle of Lutathera® treatment
Arm group label:
Participants treated with Lutathera
Intervention type:
Device
Intervention name:
Photon Emission Tomography / CT (PET/CT)
Description:
PET/CT will be performed after 64Cu-DOTATATE and Lutathera® treatment
Arm group label:
Participants treated with Lutathera
Intervention type:
Drug
Intervention name:
64Cu-Dotatate
Description:
Standard of care administration of radioactive drug for PET/CT
Arm group label:
Participants treated with Lutathera
Other name:
Detectnet
Intervention type:
Drug
Intervention name:
177Lu-Dotatate
Description:
Standard of care administration of radioactive drug for PET/CT and SPECT/CT
Arm group label:
Participants treated with Lutathera
Other name:
Lutathera®
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Wisconsin - Madison
Address:
City:
Madison
Zip:
53705
Country:
United States
Status:
Recruiting
Contact:
Last name:
Gemma Gliori
Phone:
608-262-7269
Email:
gmgliori@wisc.edu
Start date:
November 2024
Completion date:
March 2025
Lead sponsor:
Agency:
University of Wisconsin, Madison
Agency class:
Other
Source:
University of Wisconsin, Madison
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06122610
