Using Novel Imaging to More Safely Treat Neuroendocrine Tumors

NCT ID: NCT06122610

Last Updated: 2026-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-07

Study Completion Date

2026-03-31

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.

Conditions

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Neuroendocrine Tumors Somatostatin Receptor-positive Neuroendocrine Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Participants treated with Lutathera

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

Photon Emission Tomography / CT (PET/CT)

Intervention Type DEVICE

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

64Cu-Dotatate

Intervention Type DRUG

Standard of care administration of radioactive drug for PET/CT

177Lu-Dotatate

Intervention Type DRUG

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

Interventions

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

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

Intervention Type DEVICE

Photon Emission Tomography / CT (PET/CT)

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

Intervention Type DEVICE

64Cu-Dotatate

Standard of care administration of radioactive drug for PET/CT

Intervention Type DRUG

177Lu-Dotatate

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

Intervention Type DRUG

Other Intervention Names

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Detectnet Lutathera®

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Changhee Lee, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin - Madison

Madison, Wisconsin, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Radiology Studies

Role: CONTACT

608-282-8349

Other Identifiers

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Protocol Version 12/12/2025

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/RADIOLOGY/RADIOLOGY

Identifier Type: OTHER

Identifier Source: secondary_id

2023-0121

Identifier Type: -

Identifier Source: org_study_id

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