Yttrium-90 DOTA-TOC Intra-arterial (IA) Peptide Receptor Radionuclide Therapy (PRRT) for Neuroendocrine Tumor
This is a prospective, pilot, single center, open-label study in patients with metastatic neuroendocrine tumor. Eligible participants will undergo baseline assessments at enrollment. Study participants will receive a one-time administration of 90Y-DOTA-TOC via the hepatic artery. Participants in the correlative sub-study will receive 68Ga-DOTA-TOC concurrent with the 90Y-DOTA-TOC dose, and undergo additional imaging and assessment.
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
|Eligible Ages||18 Years and Over|
Inclusion Criteria:1. Biopsy proven neuroendocrine tumor, which is somatostatin receptor positive as demonstrated on somatostatin receptor PET. 1. All sites or origin are eligible. 2. Functional and nonfunctional tumors are allowed. 2. Hepatic metastases on imaging meeting the following criteria: a. Liver-only or liver-dominant metastases, defined as: i. At least 10% liver parenchyma replacement by tumor, but less than 70% replacement of the hepatic parenchyma by tumor. 1. For the imaging sub-study: at least one liver lesion must measure greater than 2 cm in size 2. For the imaging sub-study: treatment must only be performed using a single dose, and so arterial variant anatomy that would result in a split treatment will not be allowed ii. And, progression of the liver metastases demonstrated within the past twelve months defined as either: 1. Appearance of any new liver lesion or 2. 20% increase in size of at least one liver lesion. iii. Presence of low-volume extrahepatic lesions (including primary tumor) is allowed if they are stable and asymptomatic. b. SUVmax on 68Ga-DOTA-TOC PET of the liver metastases two times greater than the adjacent liver parenchyma. 3. Not a candidate for surgical debulking. 4. ECOG performance status 0, 1 or 2 5. Age > 18. 6. Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion Criteria:1. Patients not capable of getting PET study due to weight, claustrophobia, or inability to lie still for the duration of the exam. a. For patients in the imaging correlate sub-study: contraindication for undergoing MRI based on UCSF Radiology guidelines. 2. Contraindication to hepatic arteriography (e.g. hepatic artery dissection and/or thrombosis, uncorrectable coagulopathy, severe allergy to iodinated contrast, severe vascular disease precluding safe hepatic artery catheterization). 3. Any patient receiving treatment with short-acting octreotide, which cannot be interrupted for 48 hours before and 24 hours after the administration of 90Y-DOTA-TOC, or any patient receiving treatment with octreotide LAR or lanreotide, which cannot be interrupted for at least 4 weeks before the administration of 90Y-DOTA-TOC. a. Concurrent somatostatin receptor analog (SSA) allowed if progression has been documented and the SSA dose has been stable for at least two months. Long-acting SSA cannot be given within four weeks of treatment and short-acting SSA cannot be given with 48 hours of treatment. SSA therapy can restart one day after treatment. 4. Interferon, everolimus (mTOR-inhibitors), sunitinib or other systemic therapies within 4 weeks prior to enrollment. Bevacizumab within 6 weeks prior to enrollment. 5. Any liver directed treatment (surgery, radioembolization, chemoembolization, chemotherapy and radiofrequency ablation) within 12 weeks prior to enrollment. 6. Any external beam radiation treatment for hepatic disease. Prior external beam radiation therapy to more than 25% of the bone marrow. a. Prior systemic PRRT treatment is allowed, if it was performed at least six months prior. 7. Pregnancy or lactation. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation 8. Impaired liver function 1. AST (SGOT) / ALT (SGPT) > 3 x ULN. 2. Total bilirubin >1.5 x ULN 3. Serum albumin <3.0 g/dL unless prothrombin time is within the normal range. 4. Thrombosis of the main portal vein 5. Clinical evidence of ascites (trace ascites on imaging acceptable). 9. Impaired bone marrow reserve 1. Hb concentration < 8.0 g/dL; 2. Total WBC <2x109/L (2000/mm3); 3. Platelets <75x109/L (75x103/mm3). 10. Creatinine clearance <50 mL/min calculated by the Cockroft Gault method. 11. Known intracranial metastases.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 0: Exploratory study involving very limited human exposure to the drug to determine whether a drug is modulating its target.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
|Early Phase 1|
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Prior to the procedure, the patient will be instructed to fast overnight. Upon arrival to the hospital intravenous (IV) access will be placed, and Additionally, a scopolamine patch may be placed the night prior to treatment. Additionally a Foley catheter will be placed. Starting 30 minutes prior to the administration of 90Y-DOTA-TOC, an amino acid solution will be administered via
- IV. An angiographic catheter will be directed under fluoroscopic guidance to the appropriate location in the hepatic artery.
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