Gastroenteropancreatic neuroendocrine neoplasms
Conditions
Interventions
Single bolus injection of PHT001
Sponsors
Amsterdam UMC
Eligibility
Inclusion criteria
Inclusion criteria: • Patients undergoing surgery for a primary GEP-NEN (stomach, duodenum, ampulla of Vater, pancreas, jejunum, ileum, colon or rectum), of any stage, grade and intent (i.e. curative/palliative) or metastases of a GEP-NEN; • SSTR-2 positive disease, as proven by a DOTATATE PET scan pre-operatively (conducted at location AMC and part of standard care); • Age of 18 years and older; • Written informed consent.
Exclusion criteria
Exclusion criteria: • NEN, not meeting the inclusion criteria (non-GEP-NEN, unknown location); • Pregnant or breast-feeding women; • Known hypersensitivity to the investigational medicinal product (IMP) or any of its components; • Patients with an allergic/infusion reaction to 1 mg of TOC test dose of the unlabelled TOC; • Patients with known allergies to intravenous radiographic contrast agents; • Patients who have not provided a signed informed consent form to participate in the study, prior to the start of any protocol related activities; • Patients who, within the last 30 days, have participated in any clinical study of a therapeutic agent which may interfere with the safety or efficacy analysis of the IMP; • Serious non-malignant disease (e.g. psychiatric infectious, autoimmune, metabolic, renal, hepatic, cardiovascular or hematological), that may interfere with the objectives of the study or with the safety of the subject, as judged by the investigator; • A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms); • A history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalaemia, family history of Long QT Syndrome); • The use of concomitant medications that prolong the QT/QTc interval.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.No. of (serious) adverse events and suspected unexpected serious adverse reactions; 2.Identify the dose with the optimal tumour-to-background ratio; 3.Ex vivo validation of targeted uptake by tumour tissue by histopathology. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Comparison of no. of (additionally) identified (metastatic) GEP-NENs using intraoperative fluorescent imaging compared to preoperative 68Ga-DOTATATE PET imaging and histopathological examination; 2. Complete removal of tumour tissue. | — |
Contacts
Public ContactEnes Kacmaz
Amsterdam UMC
Outcome results
None listed