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Radiopharmaceutical

Novel Imaging Techniques for Neuroendocrine Tumors

Phase 1
Recruiting
Led By Steve Cho, MD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Candidates for 177Lu-DOTATATE (Lutathera) treatment for somatostatin receptor-positive neuroendocrine tumor
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 hour post-dose, 4 hours post-dose, 48 hours post-dose, 96 hours post-dose
Awards & highlights
No Placebo-Only Group

Summary

This trial seeks to find out if PET/CT scans can improve safety of a cancer treatment for neuroendocrine tumors. Participants will have 6 visits for scans.

Who is the study for?
This trial is for people with neuroendocrine tumors who are candidates for a treatment called Lutathera. Participants should be able to lie flat and tolerate PET/CT or SPECT/CT scans without known incompatibilities, and must be likely to follow study procedures.
What is being tested?
The study tests if DetectnetTM PET/CT can make Lutathera therapy safer. It involves two phases with six visits where participants undergo additional research PET/CT, and possibly SPECT/CT scans.
What are the potential side effects?
Potential side effects may include discomfort from lying still during scans, reactions to contrast agents used in imaging (like itching or rash), radiation exposure risks, and anxiety from being in enclosed spaces during the scan.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a candidate for a specific treatment targeting my neuroendocrine tumor.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 hour post-dose, 4 hours post-dose, 48 hours post-dose, 96 hours post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 hour post-dose, 4 hours post-dose, 48 hours post-dose, 96 hours post-dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Compare pre-therapy and post-therapy voxel-based dosimetry estimates
Secondary study objectives
Absorbed radiation doses
Absorbed radiation doses of 64Cu-DOTATATE
Compare 3D voxel-based versus model based dosimetry in participants receiving 177Lu_DOTATATE

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Participants treated with LutatheraExperimental Treatment4 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT)
2020
N/A
~20
177Lu-Dotatate
2020
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,231 Previous Clinical Trials
3,199,875 Total Patients Enrolled
4 Trials studying Neuroendocrine Tumors
55 Patients Enrolled for Neuroendocrine Tumors
Steve Cho, MDPrincipal InvestigatorUniversity of Wisconsin, Madison
4 Previous Clinical Trials
29 Total Patients Enrolled
~7 spots leftby Mar 2025
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