DOTATATE, COPPER (64CU) CHLORIDE for Neuroendocrine neoplasms | Gastroenteropancreatic neuroendocrine tumor

Inclusion criteria

• {"criterion_text":"- Age above or of 18 years"}
• {"criterion_text":"- Histopathologically verified gastro-pancreatic neuroendocrine neoplasm (GEP-NEN: GEP NET G1-G3 or GEP-NEC) or unknown primary tumor with NEN-positive metastases suggesting GEP origin on pathology examination."}
• {"criterion_text":"- Must be able to read and understand the patient information in Danish and to give informed consent."}
• {"criterion_text":"- WHO Performance status 0-2."}

Exclusion criteria

• {"criterion_text":"- Pregnancy"}
• {"criterion_text":"- Localized neuroendocrine neoplasms of the appendix, the rectum measuring < 1 cm, and ECL-omas of the stomach"}
• {"criterion_text":"- History of allergic reaction attributable to compounds of similar chemical or biologic composition to 18FDG or 64Cu-DOTATATE"}
• {"criterion_text":"- Breast-feeding"}
• {"criterion_text":"- Weights more than the maximum weight limit for the PET/CT bed of the scanner (140 kg)"}
• {"criterion_text":"- Uncontrolled diabetes"}
• {"criterion_text":"- Uncontrolled infection"}
• {"criterion_text":"- Exacerbation in autoimmune diseases"}
• {"criterion_text":"- Other active cancer disease"}
• {"criterion_text":"- Conditions or diseases (e.g. uncontrolled Parkinson’s disease) making the patient unable to lie still in the scanner"}
• {"criterion_text":"- Severe claustrophobia"}

Primary endpoints

• {"endpoint_text":"- Progression free survival (PFS).","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Overall survival (OS)","definition_or_measurement_approach":""}
• {"endpoint_text":"- The proportion of patients who are considered eligible for peptide receptor radionuclide therapy based on their 64Cu-DOTATATE PET/CT scan","definition_or_measurement_approach":""}
• {"endpoint_text":"- The correlation between standardized uptake values from tumors and healthy tissues derived from manually depicted regions-of-interests measured on 18FDG and 64Cu-DOTATATE","definition_or_measurement_approach":""}

Denmark

Earliest CTIS Part Ii Submission Date

13-08-2024

Latest Decision Or Authorization Date

20-08-2024

Processing Time Days

7

Number Of Sites

1

Number Of Participants

200

Primary sponsor

Full Name

Rigshospitalet

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Hospital/Clinic/Other health care facility"}