Al18F-NOTA-octreotide PET Imaging in Neuroendocrine Tumors

NCT04552847 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2022-02-17

No results posted yet for this study

Summary

The aim of this study is to evaluate the diagnostic performance of Al18F-NOTA-octreotide PET imaging in comparison with the current golden standard, 68Ga-DOTA-somatostatin analog PET, in neuroendocrine tumor patients.

Conditions

Interventions

DRUG

Al18F-NOTA-octreotide

One intravenous injection of 4 MBq/kg

DEVICE

PET/CT

Patients in part A of the trial will undergo a whole-body PET/CT scan 120 minutes (acceptable range: 105 - 240 minutes) after injection of the tracer. The CT-scan is a low-dose CT that will be acquired for both PET attenuation correction and anatomical information.

DEVICE

PET/MR

Patients in part B of the trial will undergo a whole-body PET/MR scan 120 minutes (acceptable range: 105 - 240 minutes) after injection of the tracer. The MR scan is a fully diagnostic MR requiring intravenous contrast (Dotarem®) injection and Buscopan® administration to minimize bowel movement.

Sponsors & Collaborators

  • University Hospital, Antwerp

    collaborator OTHER
  • University Hospital, Ghent

    collaborator OTHER
  • NETwerk, Belgium

    collaborator UNKNOWN
  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Christophe Deroose, MD, PhD · Universitaire Ziekenhuizen KU Leuven

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-07
Primary Completion
2022-02-08
Completion
2022-02-08

Countries

  • Belgium

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04552847 on ClinicalTrials.gov