NCT06122610

Using Novel Imaging to More Safely Treat Neuroendocrine Tumors

Dosimetry-Guided 177Lu-DOTATATE Treatment Planning Using 64Cu-DOTATATE as a Surrogate

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Neuroendocrine Tumors
• Somatostatin Receptor-positive Neuroendocrine Tumor

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-03-07
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2023-11-08
• Last updated: 2026-03-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study