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Using Novel Imaging to More Safely Treat Neuroendocrine Tumors

Sponsor
University of Wisconsin, Madison (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06122610
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
11
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Dosimetry-Guided 177Lu-DOTATATE Treatment Planning Using 64Cu-DOTATATE as a Surrogate
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

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®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Compare pre-therapy and post-therapy voxel-based dosimetry estimates [Baseline and 96 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 Outcome Measures

    1. Absorbed radiation doses [1 hour post-dose, 4 hours post-dose, 48 hours post-dose, 96 hours post-dose]

      Absorbed radiation doses from 177Lu-DOTATATE in organs will be summarized with descriptive statistics.

    2. Absorbed radiation doses of 64Cu-DOTATATE [1 hour post-dose, 4 hours post-dose, 48 hours post-dose, 96 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 [Baseline and 96 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Wisconsin - Madison Madison Wisconsin United States 53705

    Sponsors and Collaborators

    • University of Wisconsin, Madison

    Investigators

    • Principal Investigator: Steve Cho, MD, University of Wisconsin, Madison

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Wisconsin, Madison
    ClinicalTrials.gov Identifier:
    NCT06122610
    Other Study ID Numbers:
    • 2023-0121
    • Protocol Version 10/3/22
    • SMPH/RADIOLOGY/RADIOLOGY
    First Posted:
    Nov 8, 2023
    Last Update Posted:
    Nov 8, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by University of Wisconsin, Madison
    neuroendocrine tumors
    Additional relevant MeSH terms:
    Neoplasms
    Neuroendocrine Tumors
    Lutetium Lu 177 dotatate

    Study Results

    No Results Posted as of Nov 8, 2023