Lutathera in People With Gastroenteropancreatic (GEP), Bronchial or Unknown Primary Neuroendocrin… (NCT04544098) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
Lutathera in People With Gastroenteropancreatic (GEP), Bronchial or Unknown Primary Neuroendocrine Tumors That Have Spread to the Liver
United States10 participantsStarted 2020-09-02
Plain-language summary
This study will look at whether it is practical and safe to give Lutathera directly into an artery of the liver (hepatic intraarterial infusion). The researchers will compare the effects of hepatic intraarterial infusion in the liver with the effects of the standard approach (intravenous infusion in the arm). The researchers will also determine whether Lutathera is effective against participants' cancer.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Ability to understand and willingness to sign a written informed consent document
✓. Aged 18 years or older
✓. Histologically proven or cytologically confirmed, non-resectable,GEP, bronchial or unknown primary NETs with liver-dominant disease with or without prior treatment with embolization
✓. Measurable disease as defined by RECIST 1.1 with at least one dimension ≥ 1.0 cm
✓. GEP or unknown primary NET of grade 1, 2 and 3 according to WHO 2017, typical or atypical lung carcinoid according to the Travis classification of 2004
✓. Progression of disease defined by one of the following occurring within 6 months of study entry:
✓. At least a 20% increase in radiologically or clinically measurable disease;
✓. Appearance of any new lesion;
Exclusion criteria
✕. Women who are pregnant or breastfeeding
✕. History of allergic reactions attributed to compounds of similar chemical or biologic composition to 177Lu-DOTATATE as assessed from medical records.
✕. Life expectancy \< 6 months as assessed by the treating physician.
✕. Over 80% liver involvement by tumor per the judgement of the radiologist
What they're measuring
1
number of patients who successfully complete 2 IA injections