Exploration of Molecular Biomarkers for Lu-177 DOTATATE Therapy in Midgut Neuroendocrine Tumor (GENEBIOLuNET)
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|ClinicalTrials.gov Identifier: NCT03667092|
Recruitment Status : Recruiting
First Posted : September 12, 2018
Last Update Posted : August 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Midgut Neuroendocrine Tumors||Biological: non-drug intervention type||Not Applicable|
Internal vectorized therapy using Lu-177 Dotatate (abbreviated peptide receptor radionuclide therapy) was recently shown to improve progression free survival and response in metastatic progressive midgut neuroendocrine tumors (NETTER-1 phase III trial).
Lu-177 Dotatate is administered as a series of four consecutive intra veinous injections of an activity of 7.4 gigabequerel every 8 weeks.
In order to identify potential biomarkers of radio sensitivity to Lu-177 Dotatate, investigators aim to study the stability of gene/miRNA transcripts in the absence of Lu-177 Dotatate or at 6 months after treatment as well as the variations in transcript analysis after 2 Lu-177 Dotatate injections and at the end of the treatment.
Transcript variation analysis will be confronted and correlated with peripheral blood pharmacokinetic studies aimed at calculating time activity curves and provide biodosimetry information; other correlations with imaging modalities assessment of dosimetry or disease response to treatment or toxicity effects induced by Lu-177 Dotatate will also be studied.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study for Measuring Molecular Biomarkers and Their Capacity to Characterize Radionuclide Therapy With Lu-177 DOTATATE) in Metastatic G1-G2 Neuroendocrine Midgut Tumors|
|Actual Study Start Date :||September 1, 2018|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||December 2021|
Experimental: Non-drug intervention type
Exploration of gene transcript variation on seriate blood samples before treatment, before and after the 2nd and the 4th Lu-Dotatate injection and before and after the 6 month post treatment follow-up.
Measures of stability and reproducibility of selected gene transcripts and miRNA as radio sensitivity genes or progressive metastatic midgut neuroendocrine tumors genetic signatures before and during Lu-177 Dotatate internal vectorized therapy, as well as on the 6-month follow-up.
Biological: non-drug intervention type
8 peripheral blood samples (8x5ml) will be obtained at different times ; before, during and after treatment
Other Name: Blood samples
- Peptide receptor radionuclide therapy radio-induction variation of radiosensibility/reparation genes [ Time Frame: Change from before at during treatment ]Variations in gene transcripts will be registered and processed by a bio-informatician
- Evaluation of gene transcript variations [ Time Frame: during treatment and until 48 hours after treatment ]Analysis of gene transcript variation by quantitative real-time polymerase chain reaction
- Evaluation of interindividual variability with NONMEN software [ Time Frame: during treatment and until 48 hours after treatment ]Analysis of Lu-177 DOTATATE plasma concentration during treatment and 48 hours after treatment
- Evaluation of therapeutic response according to RECIST criteria [ Time Frame: 6 months post therapy ]Correlation between gene variations and the therapeutic response assessed on RECIST criteria
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03667092
|Contact: Isabelle BERRY, MD, PhD||0531156157 ext firstname.lastname@example.org|
|Contact: Lavinia VIJA, MD, PhD||0531155647 ext email@example.com|
|CHU de Toulouse||Recruiting|
|Toulouse, France, 31059|
|Study Chair:||Lavinia VIJA, MD, PhD||University Hospital, Toulouse|