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Intra-arterial Hepatic (IAH) Infusion of Radiolabelled Somatostatin Analogs in GEP-NET Patients With Dominant Liver Metastases (LUTARTERIAL)

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ClinicalTrials.gov Identifier: NCT04837885
Recruitment Status : Not yet recruiting
First Posted : April 8, 2021
Last Update Posted : April 8, 2021
Sponsor:
Collaborator:
Advanced Accelerator Applications
Information provided by (Responsible Party):
University Hospital, Bordeaux

Study Description
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Brief 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. 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).

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumor Liver Metastases Neuroendocrine Gastroenteropancreatic Tumour 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 Phase 2

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. We 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. (Based on literature data, an average enhancement ratio of 3.75 is expected from intra-arterial injection compared to intravenous results; Kratochwil 2010). 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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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"
Estimated Study Start Date : September 1, 2021
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : September 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 68Ga-DOTA-peptides PET/CT
68Ga-DOTA-peptides injections for targeted liver metastases in Positron emission tomography-computed tomography (PET/CT)
 Procedure: Positron emission tomography computed tomography (PET/CT) with Intra-hepatic (IAH) injection
Intra-hepatic injection of 68Ga-DOTA-peptides for targeted liver metastases in Positron emission tomography-computed tomography (PET/CT)

Procedure: Positron emission tomography computed tomography (PET/CT) with Intravenous (IV) injection
intravenous injection of 68Ga-DOTA-peptides for targeted liver metastases in Positron emission tomography-computed tomography (PET/CT)
Experimental: LUTATHERA® by intra-arterial hepatic injection (IAH)
One treatment dose of LUTATHERA® by intra-arterial hepatic injection after conventional treatment by 4 intravenous administrations
 Procedure: Positron emission tomography computed tomography (PET/CT) with Intra-hepatic (IAH) injection
Intra-hepatic injection of 68Ga-DOTA-peptides for targeted liver metastases in Positron emission tomography-computed tomography (PET/CT)

Procedure: Positron emission tomography computed tomography (PET/CT) with Intravenous (IV) injection
intravenous injection of 68Ga-DOTA-peptides for targeted liver metastases in Positron emission tomography-computed tomography (PET/CT)

Drug: LUTATHERA® by intra-arterial hepatic (IAH) injection

One treatment dose of LUTATHERA® by IAH injection for the 10 first patients with an PET/CT ratio greater then 3.

The LUTATHERA® by intra-arterial hepatic injection treatment is realised after the conventional treatment by 4 intravenous administrations


Procedure: Scan
Scans after completion of LUTATHERA® treatment injection


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Standardized uptake value (SUVmax) on healthy liver [ Time Frame: Day 0 (First PET/CT) ]
    Standardized uptake value (SUVmax) on healthy liver obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides

  2. Standardized uptake value (SUVmax) on healthy liver [ Time Frame: Day 3 (second PET/CT) ]
    Standardized uptake value (SUVmax) on healthy liver obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides

  3. Standardized uptake value (SUVmax) on kidneys [ Time Frame: Day 0 (First PET/CT) ]
    Standardized uptake value (SUVmax) on kidneys obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides

  4. Standardized uptake value (SUVmax) on kidneys [ Time Frame: Day 3 (second PET/CT) ]
    Standardized uptake value (SUVmax) on kidneys obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides

  5. Standardized uptake value (SUVmax) on bone marrow [ Time Frame: Day 0 (First PET/CT) ]
    Standardized uptake value (SUVmax) on bone marrow obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides

  6. Standardized uptake value (SUVmax) on bone marrow [ Time Frame: Day 3 (second PET/CT) ]
    Standardized uptake value (SUVmax) on bone marrow obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides

  7. Standardized uptake value (SUVmax) on spleen [ Time Frame: Day 0 (First PET/CT) ]
    Standardized uptake value (SUVmax) on spleen obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides

  8. Standardized uptake value (SUVmax) on spleen [ Time Frame: Day 3 (second PET/CT) ]
    Standardized uptake value (SUVmax) on spleen obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides

  9. 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 obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides

  10. Standardized uptake value (SUVmax) on associated extra-hepatic metastases [ Time Frame: Day 3 (second PET/CT) ]
    Standardized uptake value (SUVmax) on associated extra-hepatic metastases obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides

  11. 177Lu-DOTA-peptide dosimetry [ Time Frame: Day 18 ]
    Absorbed dose in different tissue of the 5 hepatic targets, possible extra-hepatic lesions and healthy organs (healthy liver, kidney, bone marrow, spleen)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)
  • 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
  • With no evidence of hematologic alteration after 4 LUTATHERA® cycles: hemoglobin ≥ 8 g/dL, neutrophils ≥ 1500/ mm3, platelets ≥ 100.000/mm3
  • Age ≥ 18 years, no superior limit
  • Contraception required in pre-menopausal female 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

Exclusion Criteria:

  • 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 <3.0 g/dL unless prothrombin time is within the normal range.
  • 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
Contacts and Locations
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Information from the National Library of Medicine

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): NCT04837885


Contacts
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Contact: Ghoufrane TLILI, Dr 05 57 65 64 08 ghoufrane.tlili@chu-bordeaux.fr
Contact: Macary Guillaume 05 57 62 32 52 guillaume.macary@chu-bordeaux.fr

Locations
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France
Institut Bergonié
Bordeaux, France, 33000
Contact: Yann GODBERT, Dr       y.godbert@bordeaux.unicancer.fr   
Institut de cancérologie du Gard (ICG) - CHU de Nîmes
Nîmes, France, 30029
Contact: Vincent BOUDOUSQ, Dr       vincent.boudousq@chu-nimes.fr   
CHU Bordeaux - Hôpital Haut Lévêque
Pessac, France, 33604
Contact: Ghoufrane TLILI, Dr    05 57 65 64 08    ghoufrane.tlili@chu-bordeaux.fr   
Contact: Guillaume Macary    05 57 62 32 52    guillaume.macary@chu-bordeaux.fr   
Principal Investigator: Ghoufrane TLILI         
Institut universitaire du cancer de Toulouse (IUCT) Oncopole
Toulouse, France, 31100
Contact: Frederic Courbon, Pr       courbon.frederic@iuct-oncopole.fr   
Sponsors and Collaborators
University Hospital, Bordeaux
Advanced Accelerator Applications
Investigators
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Principal Investigator: Ghoufrane TLILI University Hospital, Bordeaux
More Information
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT04837885    
Other Study ID Numbers: CHUBX 2017/47
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
Neuroendocrine tumour
Neuroendocrine gastroenteropancreatic (GEP) tumour
Liver Metastases
 68Ga- DOTA-peptides PET CT
177Lutetium-Octreotate
Peptide Receptor Radionuclide Therapy
Additional relevant MeSH terms:
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Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Liver Neoplasms
Neuroendocrine Tumors
Digestive System Neoplasms
Neoplasms by Site
Neuroectodermal Tumors
 Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplastic Processes
Pathologic Processes
Digestive System Diseases
Liver Diseases