Midgut Neuroendocrine TumorsGENEBIOLuNETNCT03667092
Exploration of Molecular Biomarkers for Lu-177 DOTATATE Therapy in Midgut Neuroendocrine Tumor
A study testing non-drug intervention type in people with Midgut Neuroendocrine Tumors, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Midgut neuroendocrine tumours present an increasing incidence and poor survival at 5 years with limited therapeutic options for metastatic, non-operable cases. Lu-177 Dotatate, targeting somatostatin receptors, is an internal vectorized radiotherapy using Lu-177, an ideal radionuclide for peptide radionuclide therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Midgut Neuroendocrine Tumors
- What is being tested?
- non-drug intervention type
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2018to 22 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥18 years old; histopathologically confirmed grade 1-2 midgut neuroendocrine tumor with documented progression during the year preceding inclusion upon RECIST criteria on computerized tomography, Octreoscan or Ga-68 positron emission tomography/computerized tomography
- 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.
Who cannot join
- Patients on chemotherapy or other targeted therapy within the 4 months preceding peptide receptor radionuclide therapy
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Midgut neuroendocrine tumours present an increasing incidence and poor survival at 5 years with limited therapeutic options for metastatic, non-operable cases. Lu-177 Dotatate, targeting somatostatin receptors, is an internal vectorized radiotherapy using Lu-177, an ideal radionuclide for peptide radionuclide therapy. In NETTER-1 phase III randomized clinical trial, Lu-177 Dotatate proved its superiority in increasing progression free survival for midgut neuroendocrine tumors. This study hypothesize that finding biomarkers of individual radio sensitivity for this type of internal vectorized therapy would allow treatment personalization. The protocol aim at studying transcript variations induced by this therapy.
Read the detailed description
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.
- Conditions
- Midgut Neuroendocrine Tumors
- Being tested
- non-drug intervention type
- Keywords
- Lu-177 Dotatate, transcript analysis and variation, molecular biomarkers, midgut neuroendocrine tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-drug intervention typeBiological
Also called Blood samples
8 peripheral blood samples (8x5ml) will be obtained at different times ; before, during and after treatment
| Study group | Role | What they receive |
|---|---|---|
| Non-drug intervention type | Experimental | 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. Receives: Biological: non-drug intervention type |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peptide receptor radionuclide therapy radio-induction variation of radiosensibility/reparation genes
Variations in gene transcripts will be registered and processed by a bio-informatician
Measured: Change from before at during treatment
Secondary outcomes (3)
Evaluation of gene transcript variations
Analysis of gene transcript variation by quantitative real-time polymerase chain reaction
Measured: during treatment and until 48 hours after treatment
Evaluation of interindividual variability with NONMEN software
Analysis of Lu-177 DOTATATE plasma concentration during treatment and 48 hours after treatment
Measured: during treatment and until 48 hours after treatment
Evaluation of therapeutic response according to RECIST criteria
Correlation between gene variations and the therapeutic response assessed on RECIST criteria
Measured: 6 months post therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start1 Sep 2018
- Primary completion22 May 2024
- Study completion22 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Midgut Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lavinia VIJA, MD, PhD, Study chair, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03667092
- Sponsor's protocol ID
- RC31/17/0356
- Acronym
- GENEBIOLuNET
- Status last verified
- Apr 2025
- First submitted
- 27 Jul 2018
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jacques V, Dierickx L, Texier JS, Brillouet S, Courbon F, Guimbaud R, Vija L, Savagner F. Evaluation of a blood miRNA/mRNA signature to follow-up Lu-PRRT therapy for G1/G2 intestinal neuroendocrine tumors. Front Endocrinol (Lausanne). 2024 Jun 14;15:1385079. doi: 10.3389/fendo.2024.1385079. eCollection 2024.
PubMed 38948517
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03667092
- Acronym / sponsor ID
- GENEBIOLuNET / RC31/17/0356
- Conditions
- Midgut Neuroendocrine Tumors
- Keywords
- Lu-177 Dotatate, transcript analysis and variation, molecular biomarkers, midgut neuroendocrine tumors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 22 May 2024 (actual)
- Study completion
- 22 May 2024 (actual)
- First posted
- 12 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Midgut neuroendocrine tumours present an increasing incidence and poor survival at 5 years with limited therapeutic options for metastatic, non-operable cases. Lu-177 Dotatate, targeting somatostatin receptors, is an internal vectorized radiotherapy using Lu-177, an ideal radionuclide for peptide radionuclide therapy. In NETTER-1 phase III randomized clinical trial, Lu-177 Dotatate proved its superiority in increasing progression free survival for midgut neuroendocrine tumors. This study hypothesize that finding biomarkers of individual radio sensitivity for this type of internal vectorized therapy would allow treatment personalization. The protocol aim at studying transcript variations induced by this therapy.
Detailed description
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-drug intervention type | Experimental | Biological: non-drug intervention typeExploration 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients ≥18 years old; histopathologically confirmed grade 1-2 midgut neuroendocrine tumor with documented progression during the year preceding inclusion upon RECIST criteria on computerized tomography, Octreoscan or Ga-68 positron emission tomography/computerized tomography
- 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.
Key exclusion criteria (5 listed)
- Patients on chemotherapy or other targeted therapy within the 4 months preceding peptide receptor radionuclide therapy
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-drug intervention typeAlso: Blood samples8 peripheral blood samples (8x5ml) will be obtained at different times ; before, during and after treatment | Biological | Non-drug intervention type |
Primary outcome
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
3 secondary outcomes
Evaluation of gene transcript variations
Time frame: during treatment and until 48 hours after treatment
Evaluation of interindividual variability with NONMEN software
Time frame: during treatment and until 48 hours after treatment
Evaluation of therapeutic response according to RECIST criteria
Time frame: 6 months post therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Derived from this study: PubMed 38948517Jacques V, Dierickx L, Texier JS, Brillouet S, Courbon F, Guimbaud R, Vija L, Savagner F. Evaluation of a blood miRNA/mRNA signature to follow-up Lu-PRRT therapy for G1/G2 intestinal neuroendocrine tumors. Front Endocrinol (Lausanne). 2024 Jun 14;15:1385079. doi: 10.3389/fendo.2024.1385079. eCollection 2024.
Related trials for Midgut Neuroendocrine Tumors
Active, not recruitingPhase 2
Pazopanib Hydrochloride in Treating Patients With Progressive Carcinoid Tumors
Foregut Neuroendocrine Tumor, Hindgut Neuroendocrine Tumor
RecruitingPhase 3
Randomized Interval Assessment Trial of Lu177-Dotatate in Slowly Progressive G1-2 Advanced Midgut Neuroendocrine Tumors
Grade1-2 Advanced Midgut Neuroendocrine Tumors (NETs)
Active, not recruitingPhase 2
Abemaciclib in Treating Patients With Advanced, Refractory, and Unresectable Digestive System Neuroendocrine Tumors
Advanced Digestive System Neuroendocrine Neoplasm, Digestive System Neuroendocrine Tumor
Recruiting
Prophylactic Cholecystectomy in Midgut NETs Patients Who Require Primary Tumor Surgery.
Midgut Carcinoid Tumor, Biliary Stones
Active, not recruitingEarly Phase 1
Study to Evaluate the Safety of Combining Two Radionuclide Therapies to Treat Mid-gut Neuroendocrine Tumors
Neuroendocrine Tumor, Malignant, Neuroendocrine Tumor Gastrointestinal, Hormone-Secreting
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lavinia VIJA, MD, PhD study chair
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-drug intervention type in people with Midgut Neuroendocrine Tumors, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peptide receptor radionuclide therapy radio-induction variation of radiosensibility/reparation genes (time frame: Change from before at during treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03667092, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.