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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The LuMEn Study: 177Lu-octreotate Treatment Outcome Prediction Using Multimodality Imaging in Refractory Neuroendocrine Tumours.

Brief 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.

Detailed Summary:

This is a feasibility study evaluating the use of 177Lutetium-octreotate in the treatment of advanced refractory Neuroendocrine Tumors.

Objectives of the study:

  1. Primary (on a lesion basis): To assess the value of the following parameters (obtained through functional and molecular imaging) for predicting the lesion-by-lesion PRRT treatment outcome:

    • 18FDG uptake on 18FDG PET/CT
    • 68Ga-octreotate uptake on 68Ga-octreotate PET/CT
    • Apparent diffusion coefficient on diffusion weighted MRI (for these 3 parameters, absolute values at baseline)
    • Tumor dosimetry on post 177Lu-octreotate SPECT/CT after each cycle.
  2. Secondary (on a patient basis): To generate a patient-based response model based on the previously defined parameters.

  3. Exploratory (on a lesion basis): To assess the value of the parameters mentioned in the primary objective for predicting the lesion-by-lesion PRRT treatment outcome:

    • absolute values of the three imaging parameters and their relative changes after each cycle;
    • serial tumor dosimetry on post-177Lu-octreotate SPECT/CT after each cycle.

Treatment will consist of 177Lu-octreotate injections in fixed activities of 7,4 GigaBecqurel each, given 11-13 weeks apart, injected intravenously with simultaneous infusion of an amino acid solution. (Before ami
Sponsor: Jules Bordet Institute

Current Primary Outcome: The time to progression (TTP) for each target lesion assessed on MRI (or on CT scan if MRI is not possible). [ Time Frame: 4 years [Anticipated] ]

TTP is defined as the time between treatment initiation and objective tumor progression with censoring of patients who die as a result of any cause.


Original Primary Outcome: the difference in the diameter for each target lesion after each cycle of the treatment measured on MRI (or on CT scan if MRI is not applicable) [ Time Frame: 3 years [Anticipated] ]

Current Secondary Outcome:

  • Best morphological response according to RECIST 1.1 [ Time Frame: 4 years [Anticipated] ]
  • Progression Free Survival [ Time Frame: 4 years [Anticipated] ]
    PFS is defined as the time between treatment initiation and the first of the following events: disease progression (clinical or radiological) or death resulting from any cause.
  • Biochemical response (evolution of NET-specific tumoral uptake). [ Time Frame: 4 years [Anticipated] ]


Original Secondary Outcome:

  • RECIST 1.1 response [ Time Frame: 3 years [Anticipated] ]
  • Progression Free Survival [ Time Frame: 3 years [Anticipated] ]
  • Biochemical response (evolution of plasma chromogranin A levels). [ Time Frame: 3 years [Anticipated] ]


Information By: Jules Bordet Institute

Dates:
Date Received: April 25, 2013
Date Started: May 2013
Date Completion: May 2017
Last Updated: April 4, 2016
Last Verified: March 2016