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Completed

NCT Number: NCT06122610

Using Novel Imaging to More Safely Treat Neuroendocrine Tumors

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

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Key information

Conditions

Neuroendocrine Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Somatostatin Receptor-positive Neuroendocrine Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Wisconsin - Madison

Madison, Wisconsin, 53705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT)

Device

SPECT/CT will be performed after first cycle of Lutathera® treatment

Photon Emission Tomography / CT (PET/CT)

Device

PET/CT will be performed after 64Cu-DOTATATE and Lutathera® treatment

64Cu-DOTATATE

Drug

Standard of care administration of radioactive drug for PET/CT

Other names: Detectnet

177Lu-DOTATATE

Drug

Standard of care administration of radioactive drug for PET/CT and SPECT/CT

Other names: Lutathera®

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 8, 2023
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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