Neuroendocrine TumorPhase 2LUTARTERIALNCT04837885
Intra-arterial Hepatic (IAH) Infusion of Radiolabelled Somatostatin Analogs in GEP-NET Patients With Dominant Liver Metastases
A Phase 2 study testing Positron emission tomography computed tomography (PET/CT) with Intra-hepatic (IAH) injection, Positron emission tomography computed tomography (PET/CT) with Intravenous (IV) injection and LUTATHERA® by intra-arterial hepatic (IAH) injection in people with Neuroendocrine Tumor and Liver Metastases, run by University Hospital, Bordeaux at 4 sites in France.
Trial summary
The management of liver metastases in neuroendocrine neoplasms is challenging. Peptide receptor radionuclide therapy with radiolabeled somatostatin analogs (SSA) is one of the most promising therapeutic options. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumor, Liver Metastases, Neuroendocrine Gastroenteropancreatic Tumour
- What is being tested?
- Positron emission tomography computed tomography (PET/CT) with Intra-hepatic (IAH) injection, Positron emission tomography computed tomography (PET/CT) with Intravenous (IV) injection and LUTATHERA® by intra-arterial hepatic (IAH) injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 4 sitesFrance
- Study dates
- 24 Sep 2021to 24 Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Histologically proven well differentiated neuroendocrine tumor (NET) of gastrointestinal or pancreatic origin (GEP).
- Patients are progressive after treatment with cold somatostatin analog (within 12 months according to RECIST), or as soon as the diagnosis is made in case of hepatic invasion > 50% without waiting for tumour progression
- Patient has received 4 standard of care LUTATHERA® cycles
- Liver Metastatic disease dominant or exclusive and assessable by RECIST 1.1, and not amenable to surgical resection after the last cycle
- ECOG performance status 0-2
- Adequate kidney and liver function: creatinine clearance ≥ 50 mL/min, ALT/AST ≤ 2,5x the upper limit of normal
Show all 11Show fewer
- With no evidence of hematologic alteration after 4 LUTATHERA® cycles: hemoglobin ≥ 8 g/dL, neutrophils ≥ 1500/ mm3, platelets ≥ 75.000/mm3
- Age ≥ 18 years, no superior limit
- Contraception required in pre-menopausal female (Intrauterine device, Progestin Pills, Combined Oral Contraceptives, Monthly Injectables, Progestin Injectables, Combined Patch, Combined Vaginal Ring, Female Sterilization, Vasectomy, Implants) and men for at least 6 months after the last LUTATHERA ® injection.
- Patient´s signed written informed consent
- Patient affiliated to a social security system
Who cannot join
- Patients with complete response defined by the absence of lesion according to RECIST 1.1 realized during morphological imaging at inclusion (chest-abdomen-pelvis CT scan and hepatic MRI)
- No residual uptake according to standard 177-Lu scintigraphy performed in the clinical routine 24 hours after each LUTATHERA IV treatment
- Carcinoid heart disease (LVEF < 40%)
- Dominant or threatening extrahepatic metastases or that may affect vital prognosis
- Contraindications to intra-hepatic arterial infusion (coagulation disorders, portal thrombosis, intra-hepatic biliary tract dilatation, digestive or biliary anastomosis or fistula, cirrhosis (Child Pugh B8 or C…)
- Serum albumin <30 g/L unless prothrombin time is within the normal range.
Show all 13Show fewer
- Heart failure, myocardial infarction, stroke, uncontrolled arterial hypertension under optimal treatment (≥ 160/95 mmHg), pulmonary embolism or revascularization procedure, unstable angina pectoris, uncontrolled cardiac arrhythmia, and clinically significant bradycardia during the last 12 months.
- Individuals under legal protection or unable of giving their informed consent
- Pregnancy or breast feeding
- Currently participating to another clinical research protocol
- Individuals under legal protection or unable of giving their informed consent
- MRI scan contraindicated
- LUTATHERA® contraindicated or toxicity during one of the IV administrations leading to a reduction or cancellation of the following dose
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Not yet recruiting
Institut Bergonié
Bordeaux, 33000
Yann GODBERT, Dr, y.godbert@bordeaux.unicancer.fr
- Not yet recruiting
Institut de cancérologie du Gard (ICG) - CHU de Nîmes
Nîmes, 30029
Vincent BOUDOUSQ, Dr, vincent.boudousq@chu-nimes.fr
- Recruiting
CHU Bordeaux - Hôpital Haut Lévêque
Pessac, 33604
Ghoufrane TLILI, Dr, 05 57 65 64 08, ghoufrane.tlili@chu-bordeaux.fr
Guillaume Macary, 05 57 62 32 52, guillaume.macary@chu-bordeaux.fr
- Not yet recruiting
Institut universitaire du cancer de Toulouse (IUCT) Oncopole
Toulouse, 31100
Frederic Courbon, Pr, courbon.frederic@iuct-oncopole.fr
About this study
Official title: "Imaging With 68Ga-DOTA-peptides and Peptide Receptor Radionuclide Therapy With 177Lu-DOTA-peptides of Gastroenteropancreatic Neuroendocrine Tumors: Interest of Intra-arterial Hepatic Infusion in Patients With Dominant Liver Metastases"
The management of liver metastases in neuroendocrine neoplasms is challenging. Peptide receptor radionuclide therapy with radiolabeled somatostatin analogs (SSA) is one of the most promising therapeutic options. As liver is the most frequent site of metastatic disease, our project proposes to compare administration of radiolabeled SSA by arterial intrahepatic infusion (experimental approach) vs intravenous administration (conventional). Evaluation will be made by (i) comparing 68Ga-DOTA-peptides uptake after intra-hepatic versus intravenous route (imaging), (ii) by evaluating the safety of an additional intra-hepatic administration of therapeutic radiolabeled SSA (therapy).
Read the detailed description
Liver metastases of neuroendocrine tumors of gastro-entero-pancreatic origin are one of the most limiting factors of patient survival. Peptide receptor radionuclide therapy with radiolabeled somatostatin analogs (SSA) such as LUTATHERA® represents now a major therapeutic option. As far as these metastases are mainly perfused by the hepatic artery, it could be relevant to deliver the treatment by intra-hepatic route, in order to achieve a maximized dose to the tumour when compared with a systemic conventional administration, while also reducing kidney and bone marrow toxicity. By using radiolabeled SSA for imaging and therapy, the present project aims to compare the uptake of 68Ga-DOTA-peptides after intra-hepatic versus intravenous injections for targeted liver metastases, as well as for dose limiting organs (kidney, spleen, healthy liver, bone marrow) and extra-hepatic lesions if present. The investigators will also evaluate whether the intra-hepatic infusion of one treatment dose of LUTATHERA® after conventional treatment by 4 intravenous administrations, is safe.
Following 4 intravenous administrations of LUTATHERA® in GEP-NET with dominant liver metastases, patients who gave informed consent will be enrolled for 2 PET-scans, the first one after intra-hepatic injection of 68Ga-DOTA-peptides and the second one after intravenous injection for purpose of uptake comparison by 5 liver metastases chosen by radiologists on MRI.
In 10 patients who meet a predefined enhancement ratio of 3, a 5th dose of LUTATHERA® will be administered by intra-arterial hepatic injection. An average enhancement ratio of 3.75 is expected from intra-arterial injection compared to intravenous results. Those 10 patients will be evaluated for 177Lu-DOTA-peptide activity and residence time by SPECT/CT imaging.
Follow-up through 18 months will include clinical examination, MRI and CT scan, as usually performed in these clinical settings and progression
- Being tested
- Positron emission tomography computed tomography (PET/CT) with Intra-hepatic (IAH) injection, Positron emission tomography computed tomography (PET/CT) with Intravenous (IV) injection, LUTATHERA® by intra-arterial hepatic (IAH) injection, Scan
- Keywords
- Neuroendocrine tumour, Neuroendocrine gastroenteropancreatic (GEP) tumour, Liver Metastases, 68Ga- DOTA-peptides PET CT, 177Lutetium-Octreotate, Peptide Receptor Radionuclide Therapy
- Medical subject headings
- Neuroendocrine Tumors, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positron emission tomography computed tomography (PET/CT) with Intra-hepatic (IAH) injectionProcedure or surgery
Intra-hepatic injection of 68Ga-DOTA-peptides for targeted liver metastases in Positron emission tomography-computed tomography (PET/CT)
Positron emission tomography computed tomography (PET/CT) with Intravenous (IV) injectionProcedure or surgery
intravenous injection of 68Ga-DOTA-peptides for targeted liver metastases in Positron emission tomography-computed tomography (PET/CT)
LUTATHERA® by intra-arterial hepatic (IAH) injectionDrug
One treatment dose of LUTATHERA® by IAH injection. The LUTATHERA® by intra-arterial hepatic injection treatment is realised after the conventional treatment by 4 intravenous administrations
ScanProcedure or surgery
Scans after completion of LUTATHERA® treatment injection
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-DOTA-peptides PET/CT | Experimental | 68Ga-DOTA-peptides injections for targeted liver metastases in Positron emission tomography-computed tomography (PET/CT)
One treatment dose of LUTATHERA® by intra-arterial hepatic injection (IAH) after conventional treatment by 4 intravenous administrations Receives: Procedure: Positron emission tomography computed tomography (PET/CT) with Intra-hepatic (IAH) injection; Procedure: Positron emission tomography computed tomography (PET/CT) with Intravenous (IV) injection; Drug: LUTATHERA® by intra-arterial hepatic (IAH) injection; Procedure: Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized uptake value (SUVmax) on liver metastases
Standardized uptake value (SUVmax) on liver metastase obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides
Measured: Day 0 (First PET/CT)
Standardized uptake value (SUVmax) on liver metastases
Standardized uptake value (SUVmax) on liver metastase obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides
Measured: Day 3 (second PET/CT)
Secondary outcomes (11)
Standardized uptake value (SUVmax) on healthy liver
Standardized uptake value (SUVmax) on healthy liver obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides
Measured: Day 0 (First PET/CT)
Standardized uptake value (SUVmax) on healthy liver
Standardized uptake value (SUVmax) on healthy liver obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides
Measured: Day 3 (second PET/CT)
Standardized uptake value (SUVmax) on kidneys
Standardized uptake value (SUVmax) on kidneys obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides
Measured: Day 0 (First PET/CT)
Standardized uptake value (SUVmax) on kidneys
Standardized uptake value (SUVmax) on kidneys obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides
Measured: Day 3 (second PET/CT)
Standardized uptake value (SUVmax) on bone marrow
Standardized uptake value (SUVmax) on bone marrow obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides
Measured: Day 0 (First PET/CT)
Standardized uptake value (SUVmax) on bone marrow
Standardized uptake value (SUVmax) on bone marrow obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides
Measured: Day 3 (second PET/CT)
Standardized uptake value (SUVmax) on spleen
Standardized uptake value (SUVmax) on spleen obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides
Measured: Day 0 (First PET/CT)
Standardized uptake value (SUVmax) on spleen
Standardized uptake value (SUVmax) on spleen obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides
Measured: Day 3 (second PET/CT)
Standardized uptake value (SUVmax) on associated extra-hepatic metastases
Standardized uptake value (SUVmax) on associated extra-hepatic metastases obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides
Measured: Day 0 (First PET/CT)
Standardized uptake value (SUVmax) on associated extra-hepatic metastases
Standardized uptake value (SUVmax) on associated extra-hepatic metastases obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides
Measured: Day 3 (second PET/CT)
177Lu-DOTA-peptide dosimetry
Absorbed dose in different tissue of the 5 hepatic targets, possible extra-hepatic lesions and healthy organs (healthy liver, kidney, bone marrow, spleen)
Measured: Day 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start24 Sep 2021
- Primary completion24 Sep 2025 (estimated)
- Study completion24 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Advanced Accelerator Applications
- Responsible party
- Sponsor
- Investigators
- Ghoufrane TLILI, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04837885
- Sponsor's protocol ID
- CHUBX 2017/47
- Acronym
- LUTARTERIAL
- Status last verified
- Jul 2025
- First submitted
- 6 Apr 2021
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Imaging With 68Ga-DOTA-peptides and Peptide Receptor Radionuclide Therapy With 177Lu-DOTA-peptides of Gastroenteropancreatic Neuroendocrine Tumors: Interest of Intra-arterial Hepatic Infusion in Patients With Dominant Liver Metastases"
- ClinicalTrials.gov ID
- NCT04837885
- Acronym / sponsor ID
- LUTARTERIAL / CHUBX 2017/47
- Keywords
- Neuroendocrine tumour, Neuroendocrine gastroenteropancreatic (GEP) tumour, Liver Metastases, 68Ga- DOTA-peptides PET CT, 177Lutetium-Octreotate, Peptide Receptor Radionuclide Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Advanced Accelerator Applications
- Study start
- 24 Sep 2021 (actual)
- Primary completion
- 24 Sep 2025 (estimated)
- Study completion
- 24 Mar 2027 (estimated)
- First posted
- 8 Apr 2021 (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.
The management of liver metastases in neuroendocrine neoplasms is challenging. Peptide receptor radionuclide therapy with radiolabeled somatostatin analogs (SSA) is one of the most promising therapeutic options. As liver is the most frequent site of metastatic disease, our project proposes to compare administration of radiolabeled SSA by arterial intrahepatic infusion (experimental approach) vs intravenous administration (conventional). Evaluation will be made by (i) comparing 68Ga-DOTA-peptides uptake after intra-hepatic versus intravenous route (imaging), (ii) by evaluating the safety of an additional intra-hepatic administration of therapeutic radiolabeled SSA (therapy).
Detailed description
Liver metastases of neuroendocrine tumors of gastro-entero-pancreatic origin are one of the most limiting factors of patient survival. Peptide receptor radionuclide therapy with radiolabeled somatostatin analogs (SSA) such as LUTATHERA® represents now a major therapeutic option. As far as these metastases are mainly perfused by the hepatic artery, it could be relevant to deliver the treatment by intra-hepatic route, in order to achieve a maximized dose to the tumour when compared with a systemic conventional administration, while also reducing kidney and bone marrow toxicity. By using radiolabeled SSA for imaging and therapy, the present project aims to compare the uptake of 68Ga-DOTA-peptides after intra-hepatic versus intravenous injections for targeted liver metastases, as well as for dose limiting organs (kidney, spleen, healthy liver, bone marrow) and extra-hepatic lesions if present. The investigators will also evaluate whether the intra-hepatic infusion of one treatment dose of LUTATHERA® after conventional treatment by 4 intravenous administrations, is safe.
Following 4 intravenous administrations of LUTATHERA® in GEP-NET with dominant liver metastases, patients who gave informed consent will be enrolled for 2 PET-scans, the first one after intra-hepatic injection of 68Ga-DOTA-peptides and the second one after intravenous injection for purpose of uptake comparison by 5 liver metastases chosen by radiologists on MRI.
In 10 patients who meet a predefined enhancement ratio of 3, a 5th dose of LUTATHERA® will be administered by intra-arterial hepatic injection. An average enhancement ratio of 3.75 is expected from intra-arterial injection compared to intravenous results. Those 10 patients will be evaluated for 177Lu-DOTA-peptide activity and residence time by SPECT/CT imaging.
Follow-up through 18 months will include clinical examination, MRI and CT scan, as usually performed in these clinical settings and progression
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-DOTA-peptides PET/CT | Experimental | Procedure: Positron emission tomography computed tomography (PET/CT) with Intra-hepatic (IAH) injection, Procedure: Positron emission tomography computed tomography (PET/CT) with Intravenous (IV) injection, Drug: LUTATHERA® by intra-arterial hepatic (IAH) injection, Procedure: Scan68Ga-DOTA-peptides injections for targeted liver metastases in Positron emission tomography-computed tomography (PET/CT) One treatment dose of LUTATHERA® by intra-arterial hepatic injection (IAH) after conventional treatment by 4 intravenous administrations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically proven well differentiated neuroendocrine tumor (NET) of gastrointestinal or pancreatic origin (GEP).
- Patients are progressive after treatment with cold somatostatin analog (within 12 months according to RECIST), or as soon as the diagnosis is made in case of hepatic invasion > 50% without waiting for tumour progression
- Patient has received 4 standard of care LUTATHERA® cycles
- Liver Metastatic disease dominant or exclusive and assessable by RECIST 1.1, and not amenable to surgical resection after the last cycle
- ECOG performance status 0-2
Key exclusion criteria (13 listed)
- Patients with complete response defined by the absence of lesion according to RECIST 1.1 realized during morphological imaging at inclusion (chest-abdomen-pelvis CT scan and hepatic MRI)
- No residual uptake according to standard 177-Lu scintigraphy performed in the clinical routine 24 hours after each LUTATHERA IV treatment
- Carcinoid heart disease (LVEF < 40%)
- Dominant or threatening extrahepatic metastases or that may affect vital prognosis
- Contraindications to intra-hepatic arterial infusion (coagulation disorders, portal thrombosis, intra-hepatic biliary tract dilatation, digestive or biliary anastomosis or fistula, cirrhosis (Child Pugh B8 or C…)
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 |
|---|---|---|
| Positron emission tomography computed tomography (PET/CT) with Intra-hepatic (IAH) injectionIntra-hepatic injection of 68Ga-DOTA-peptides for targeted liver metastases in Positron emission tomography-computed tomography (PET/CT) | Procedure or surgery | 68Ga-DOTA-peptides PET/CT |
| Positron emission tomography computed tomography (PET/CT) with Intravenous (IV) injectionintravenous injection of 68Ga-DOTA-peptides for targeted liver metastases in Positron emission tomography-computed tomography (PET/CT) | Procedure or surgery | 68Ga-DOTA-peptides PET/CT |
| LUTATHERA® by intra-arterial hepatic (IAH) injectionOne treatment dose of LUTATHERA® by IAH injection. The LUTATHERA® by intra-arterial hepatic injection treatment is realised after the conventional treatment by 4 intravenous administrations | Drug | 68Ga-DOTA-peptides PET/CT |
| ScanScans after completion of LUTATHERA® treatment injection | Procedure or surgery | 68Ga-DOTA-peptides PET/CT |
Primary outcome
Standardized uptake value (SUVmax) on liver metastases
Time frame: Day 0 (First PET/CT)
Standardized uptake value (SUVmax) on liver metastase obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides
Standardized uptake value (SUVmax) on liver metastases
Time frame: Day 3 (second PET/CT)
Standardized uptake value (SUVmax) on liver metastase obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides
11 secondary outcomes
Standardized uptake value (SUVmax) on healthy liver
Time frame: Day 0 (First PET/CT)
Standardized uptake value (SUVmax) on healthy liver
Time frame: Day 3 (second PET/CT)
Standardized uptake value (SUVmax) on kidneys
Time frame: Day 0 (First PET/CT)
Standardized uptake value (SUVmax) on kidneys
Time frame: Day 3 (second PET/CT)
Standardized uptake value (SUVmax) on bone marrow
Time frame: Day 0 (First PET/CT)
Standardized uptake value (SUVmax) on bone marrow
Time frame: Day 3 (second PET/CT)
Standardized uptake value (SUVmax) on spleen
Time frame: Day 0 (First PET/CT)
Standardized uptake value (SUVmax) on spleen
Time frame: Day 3 (second PET/CT)
Standardized uptake value (SUVmax) on associated extra-hepatic metastases
Time frame: Day 0 (First PET/CT)
Standardized uptake value (SUVmax) on associated extra-hepatic metastases
Time frame: Day 3 (second PET/CT)
177Lu-DOTA-peptide dosimetry
Time frame: Day 18
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
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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.
Ghoufrane TLILI principal investigator
University Hospital, Bordeaux
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Positron emission tomography computed tomography (PET/CT) with Intra-hepatic (IAH) injection, Positron emission tomography computed tomography (PET/CT) with Intravenous (IV) injection and LUTATHERA® by intra-arterial hepatic (IAH) injection in people with Neuroendocrine Tumor and Liver Metastases, run by University Hospital, Bordeaux at 4 sites 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 11 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ghoufrane TLILI, Dr (05 57 65 64 08, ghoufrane.tlili@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized uptake value (SUVmax) on liver metastases (time frame: Day 0 (First PET/CT)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2025.