Using Novel Imaging to More Safely Treat Neuroendocrine Tumors

Neuroendocrine Tumors Clinical Trial

Official title:

Dosimetry-Guided 177Lu-DOTATATE Treatment Planning Using 64Cu-DOTATATE as a Surrogate

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06122610
• Other study ID #: 2023-0121
• Secondary ID: Protocol Version
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 2024
• Est. completion date: March 2025

Study information

• Verified date: April 2024
• Source: University of Wisconsin, Madison
• Contact: Gemma Gliori
• Phone: 608-262-7269
• Email: gmgliori[@]wisc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Neuroendocrine Tumors

Intervention

Device:
• 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

Drug:
• 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

Locations

Country	Name	City	State
United States	University of Wisconsin - Madison	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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