Using Novel Imaging to More Safely Treat Neuroendocrine Tumors

May 12, 2026 updated by: University of Wisconsin, Madison

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • Recruiting
        • University of Wisconsin - Madison
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants treated with Lutathera
Device: Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT)
SPECT/CT will be performed after first cycle of Lutathera® treatment
Device: 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
Other Names:
  • Detectnet
Drug: 177Lu-Dotatate
Standard of care administration of radioactive drug for PET/CT and SPECT/CT
Other Names:
  • Lutathera®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare pre-therapy and post-therapy voxel-based dosimetry estimates
Time Frame: 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.
Baseline and 120 hours post-dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absorbed radiation doses
Time Frame: 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.
1 hour post-dose, 4 hours post-dose, 48 hours post-dose, 120 hours post-dose
Absorbed radiation doses of 64Cu-DOTATATE
Time Frame: 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.
1 hour post-dose, 4 hours post-dose, 48 hours post-dose, 120 hours post-dose
Compare 3D voxel-based versus model based dosimetry in participants receiving 177Lu_DOTATATE
Time Frame: 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.
Baseline and 120 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Investigators

  • Principal Investigator: Changhee Lee, MD, University of Wisconsin, Madison

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

November 2, 2023

First Submitted That Met QC Criteria

November 2, 2023

First Posted (Actual)

November 8, 2023

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-0121
  • SMPH/RADIOLOGY/RADIOLOGY (Other Identifier: UW Madison)
  • Protocol Version 4/7/2026 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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