177Lutetium-octreotate Treatment Prediction Using Multimodality Imaging in Refractory NETs
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.
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
|Eligible Ages||18 Years and Over|
Inclusion Criteria:Patient-based: 1. Age above or equal to 18 years. 2. Histology-proven advanced GEP-NETs. 3. Disease progression defined as follows (at least one of the following):
- - Radiological disease progression (according to RECIST 1.1) on an MRI or CT over the last 12 months Or - Disease progression on a somatostatin receptor-imaging, PET/CT or SPECT/CT over the last 12 months [apparition of new lesion(s) or increase in the transaxial plane diameter of more than 30% on the same imaging modality] Or - Both of the following criteria (a+b): 1.
- - sustained (for more than 2 weeks) increase of NET-specific hormonal hypersecretion related symptom frequency by 50% or, - sustained (for more than 2 weeks) increase of severity by 1 grade (according to NCI-CTCAE version 4.03).
- - On the 68Ga-octreotate PET/CT: tumor uptake higher than the physiological liver uptake (grade III or IV of the Rotterdam visual score) in a lesion with longest transaxial plane diameter ≥20mm (measured on the CT, part of the PET/CT); - At least one of these lesions morphologically measurable according to RECIST 1.1 and progressive on the MRI (or CT if MRI is not applicable); - Target lesion should not have been previously irradiated.
Exclusion Criteria:1. Resectable tumor with curative intent. 2. Any major surgery within the last 6 weeks prior to inclusion in the study 3. Radiotherapy, chemotherapy, embolization, mammalian target of rapamycin (mTOR)-inhibitors, receptor tyrosine-kinase inhibitors, interferon, or other investigational therapy within the last 12 weeks prior to inclusion in the study. 4. Diffuse bone marrow infiltration on the baseline 68Ga-octreotate PET/CT confirmed by MRI. 5. Prior external beam radiotherapy on kidneys or on more than 25% of bone marrow. 6. Patients with known uncontrolled brain metastases. 7. Patients with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the investigator's opinion, may interfere with completion of the study. 8. Pregnant or lactating patients. 9. Women of childbearing potential and men with partners of child-bearing potential refusing an adequate contraception.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 0: Exploratory study involving very limited human exposure to the drug to determine whether a drug is modulating its target.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Jules Bordet Institute|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Gastroenteropancreatic Neuroendocrine Tumors|
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.
- - 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.
- - on a lesion-basis (change of longest transversal diameter).
- - on a patient-basis using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
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Jules Bordet Institute
Brussels, , B-1000