Exploration of Molecular Biomarkers for Lu-177 DOTATATE Therapy in Midgut Neuroendocrine Tumor
NCT ID: NCT03667092
Last Updated: 2025-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
47 participants
INTERVENTIONAL
2018-09-01
2024-05-22
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
non-drug intervention type
8 peripheral blood samples (8x5ml) will be obtained at different times ; before, during and after treatment
Interventions
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non-drug intervention type
8 peripheral blood samples (8x5ml) will be obtained at different times ; before, during and after treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients having an indication for Lu-177 Dotatate treatment validated during multidisciplinary meeting coordinated by Pr Rosine Guimbaud under RENATEN coordination;
* Measurable target lesions upon RECIST criteria
* Patients on somatostatin analogues treatment. Every somatostatin analogue injection should be organized to be administered 24 to 48 hours after each injection of Lu-177 Dotatate.
* All patients should be in a clinical state allowing them to continue treatment.
* Social security affiliation is mandatory.
Exclusion Criteria
* Fertile patients refusing active contraception ; pregnancy.
* Patients with prior chemotherapy or peptide receptor radionuclide therapy administration
* Patients with uncontrollable psychotic disorders
* Renal hepatic and medullary insufficiency
18 Years
ALL
No
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Lavinia VIJA, MD, PhD
Role: STUDY_CHAIR
University Hospital, Toulouse
Locations
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CHU de Toulouse
Toulouse, France, France
Countries
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Other Identifiers
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RC31/17/0356
Identifier Type: -
Identifier Source: org_study_id
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