NCT06122610

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
1mo left

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Mar 2025Jun 2026

First Submitted

Initial submission to the registry

November 2, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 8, 2023

Completed
1.3 years until next milestone

Study Start

First participant enrolled

March 7, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

November 2, 2023

Last Update Submit

March 18, 2026

Conditions

Neuroendocrine TumorsSomatostatin Receptor-positive Neuroendocrine Tumor

Keywords

neuroendocrine tumors

Outcome Measures

Primary Outcomes (1)

  • 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 120 hours post-dose

Secondary Outcomes (3)

  • Absorbed radiation doses

    1 hour post-dose, 4 hours post-dose, 48 hours post-dose, 120 hours post-dose

  • Absorbed radiation doses of 64Cu-DOTATATE

    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

    Baseline and 120 hours post-dose

Study Arms (1)

Participants treated with Lutathera

EXPERIMENTAL
Device: Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT)Device: Photon Emission Tomography / CT (PET/CT)Drug: 64Cu-DotatateDrug: 177Lu-Dotatate

Interventions

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

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

Participants treated with Lutathera
Photon Emission Tomography / CT (PET/CT)DEVICE

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

Participants treated with Lutathera
64Cu-DotatateDRUG

Standard of care administration of radioactive drug for PET/CT

Also known as: Detectnet
Participants treated with Lutathera
177Lu-DotatateDRUG

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

Also known as: Lutathera®
Participants treated with Lutathera

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Candidates for 177Lu-DOTATATE (Lutathera) treatment for somatostatin receptor-positive neuroendocrine tumor

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin - Madison

Madison, Wisconsin, 53705, United States

RECRUITING

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

Tomography, Emission-Computed, Single-PhotonTomography, X-Ray ComputedSingle Photon Emission Computed Tomography Computed TomographyPositron Emission Tomography Computed Tomography64Cu-DOTATATElutetium Lu 177 dotatate

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Tomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisImage EnhancementPhotographyRadionuclide ImagingTomographyDiagnostic Techniques, RadioisotopeRadiographic Image EnhancementRadiographyTomography, X-RayMultimodal ImagingPositron-Emission Tomography

Study Officials

  • Changhee Lee, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Radiology Studies

CONTACT

608-282-8349Radstudy@uwhealth.org

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2023

First Posted

November 8, 2023

Study Start

March 7, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)