Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04837885
Status:
UNKNOWN
Last Update Posted:
2021-12-01
First Post:
2021-04-06
Brief Title:
Intra-arterial Hepatic IAH Infusion of Radiolabelled Somatostatin Analogs in GEP-NET Patients With Dominant Liver Metastases
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2021-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LUTARTERIAL
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
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 375 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 SPECTCT imaging
Follow-up through 18 months will include clinical examination MRI and CT scan as usually performed in these clinical settings and progression
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 375 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 SPECTCT imaging
Follow-up through 18 months will include clinical examination MRI and CT scan as usually performed in these clinical settings and progression
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None