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177Lutetium-octreotate Treatment Prediction Using Multimodality Imaging in Refractory NETs

NCT01842165 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2022-11-10

No results posted yet for this study

Summary

The purpose of this study is to determine if 68Gallium-octreotate and 18Fluorodesoxyglucose uptake, apparent diffusion coefficient and post 177Lu-octreotate SPECT/CT dosimetry are reliable predictors for lesion-by-lesion treatment outcome.

Conditions

  • Gastroenteropancreatic Neuroendocrine Tumors

Interventions

DRUG

Intravenous injection of 177Lu-octreotate

Treatment will consist of 177Lu-octreotate injections in fixed activities of 7,4 GBq (200 mCi) (±5%) each, given 12 weeks (±1 week) apart, injected intravenously simultaneously with nephroprotective perfusion of an amino acid solution.

Sponsors & Collaborators

  • Jules Bordet Institute

    lead OTHER

Principal Investigators

  • Patrick Flamen, M.D., Ph.D. · Jules Bordet Institute

  • Amélie Deleporte, MD · Jules Bordet Institute

  • Alain Hendlisz, MD · Jules Bordet Institute

  • Ioannis Karfis, MD · Jules Bordet Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2022-01-14
Completion
2022-09-19

Countries

  • Belgium

Study Locations

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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 NCT01842165 on ClinicalTrials.gov