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"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" "LUTARTERIAL"

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514785-39-00
Acronym
CHUBX 2017/47
Enrollment
23
Registered
2024-11-04
Start date
2021-09-24
Completion date
Unknown
Last updated
2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adults

Brief summary

68Ga-DOTA-peptides uptake (Maximum Standardized Uptake Value) in up to 5 liver metastases on PET-scan obtained after intra-hepatic injection

Detailed description

Safety profile : safety of 177Lu-DOTA-peptide after intra-arterial hepatic administration, 68Ga-DOTA-peptide uptake (SUVmax) on dose limiting organs (kidney, spleen, healthy liver, bone marrow) after 68Ga-DOTA-peptides by arterial intrahepatic and intravenous injections, 68Ga-DOTA-peptide uptake (SUVmax) on extra-hepatic lesion (if present) after 68Ga-DOTA-peptides by arterial intrahepatic and intravenous injections, Estimate the lesional and organ (kidney, spleen, healthy liver, bone marrow) absorbed doses after 177Lu-DOTA-peptide administration by intra-arterial hepatic and intravenous injections, Efficacy evaluation of the fifth cycle of 177Lu-DOTA-peptide therapy administered by intra-arterial hepatic infusion according to RECIST1.1 criteria

Interventions

DRUGsolution injectable
DRUGXENETIX 350 (350 mg d’Iode/mL)
DRUGIMODIUM 2 mg
DRUGgélule
DRUGZOPHREN 8 mg
DRUGcomprimé pelliculé
DRUG0
DRUG85 GBq
DRUGLASILIX 40 mg
DRUGcomprimé sécable
DRUGGalliaPharm 0
DRUG74 – 1
DRUG85 GBq Radionuklidgenerator
DRUGAMLOR 10 mg

Sponsors

Centre Hospitalier Universitaire De Bordeaux
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
68Ga-DOTA-peptides uptake (Maximum Standardized Uptake Value) in up to 5 liver metastases on PET-scan obtained after intra-hepatic injection

Secondary

MeasureTime frame
Safety profile : safety of 177Lu-DOTA-peptide after intra-arterial hepatic administration, 68Ga-DOTA-peptide uptake (SUVmax) on dose limiting organs (kidney, spleen, healthy liver, bone marrow) after 68Ga-DOTA-peptides by arterial intrahepatic and intravenous injections, 68Ga-DOTA-peptide uptake (SUVmax) on extra-hepatic lesion (if present) after 68Ga-DOTA-peptides by arterial intrahepatic and intravenous injections, Estimate the lesional and organ (kidney, spleen, healthy liver, bone marrow) absorbed doses after 177Lu-DOTA-peptide administration by intra-arterial hepatic and intravenous injections, Efficacy evaluation of the fifth cycle of 177Lu-DOTA-peptide therapy administered by intra-arterial hepatic infusion according to RECIST1.1 criteria

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026