Clinical trial · Interventional
Selective Intra-arterial Injection of PRRT in Neuroendocrine Tumor Patients With Liver Metastases
Selective Intra-arterial Injection of Peptide Receptor Radionuclide Therapy (PRRT) in Neuroendocrine Tumor Patients With Liver Metastases
NCT03724409CI-TRIAL-00071767terminatedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Pandemic
Summary
Brief summary (as posted)
This is a safety study to determine the phase 1 starting dose of \[90\]Yttrium-DOTATOC when it is administered intravenously for patients with neuroendocrine tumors that have spread to the liver.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [90]Y-DOTATOC | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- Subject will be administered 2.96 gigabecquerels of \[90\]Y-DOTATOC intra-aterially to the liver
- interventionNames
- Drug: [90]Y-DOTATOC
- type
- EXPERIMENTAL
- label
- Cohort 2
- description
- Subject will be administered 3.33 gigabecquerels of \[90\]Y-DOTATOC intra-aterially to the liver
- interventionNames
- Drug: [90]Y-DOTATOC
- type
- EXPERIMENTAL
- label
- Cohort 3
- description
- Subject will be administered 3.7 gigabecquerels of \[90\]Y-DOTATOC intra-aterially to the liver
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Ability to understand and the willingness to provide informed consent * Pathologically well-differentiated neuroendocrine tumor (i.e. grade 1 or grade 2). * Primary tumor location should be known or believed to be midgut. * At least one tumor in the liver that is positive with \[68\]Ga-DOTATATE (NETSPOT). Imaging must be performed within the past 6 months. * Liver lesions not amendable to other therapies (surgery, ablation) and have progressed after treatment with octreotide/lanreotide and/or other treatments. (everolimus, sunitinib). * Karnofsky performance status of at least 70 * Absolute neutrophil count of at least 1,000 cells/mm3 * Platelet count of at least 90,000 cells / mm3 * Total bilirubin ≤ 2 x the upper limit of normal when adjusted for age * AST and ALT ≤ 5 x the upper limit of normal when adjusted for age * Serum creatinine ≤ 1.2 mg/dl; if serum creatinine is \>1.2 mg/dl nuclear GFR will used for potentially eligible participants. * Agrees to contraception. Exclusion criteria: * Liver tumor involvement greater than 70% by cross sectional imaging * Extra-hepatic visceral and osseous metastases * Concomitant therapy for tumor (except for somatostatin analogs or bisphosphonates) * Previous PRRT or other liver directed therapy within 12 months of consent * Women who are pregnant, breast feeding or breast pumping. * Another concurrent malignancy on active therapy * Previous external-beam radiation therapy to a kidney (including scatter dose) * Therapeutic investigational drug within 4 weeks of therapy. * Subjects for whom, in the opinion of their physician, a 24-hour discontinuation of somatostatin analogue therapy represents a health risk. * Sandostatin LAR injection within 4 weeks or lanreotide injection within 8 weeks of proposed therapy. * Inability to lie down supine for study procedure. * Reaction to IV contrast used for the angiogram. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring hospitalization, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
References
Publications (1)
- BACKGROUNDKennedy A, Bester L, Salem R, Sharma RA, Parks RW, Ruszniewski P; NET-Liver-Metastases Consensus Conference. Role of hepatic intra-arterial therapies in metastatic neuroendocrine tumours (NET): guidelines from the NET-Liver-Metastases Consensus Conference. HPB (Oxford). 2015 Jan;17(1):29-37. doi: 10.1111/hpb.12326. Epub 2014 Sep 4. PMID 25186181