Using Novel Imaging to More Safely Treat Neuroendocrine Tumors

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06122610
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Wisconsin, Madison
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Steve Cho, MD
Principal Investigator Affiliation University of Wisconsin, Madison
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Neuroendocrine Tumors, Somatostatin Receptor-positive Neuroendocrine Tumor
Additional Details

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.

Arms & Interventions

Arms

Experimental: Participants treated with Lutathera

Interventions

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

Drug: - 177Lu-Dotatate

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Wisconsin - Madison, Madison, Wisconsin

Status

Address

University of Wisconsin - Madison

Madison, Wisconsin, 53705

Site Contact

Gemma Gliori

gmgliori@wisc.edu

608-262-7269

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