Dual 64Cu-DOTATATE and 18F-FDG PET/CT Imaging of Patients With Neuroendocrine Neoplasms

• Status: Enrolling by invitation
• Trial end date: 2026-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Prospective clinical trial investigating combined, dual 18F-FDG PET/CT and 64Cu-DOTATATE PET/CT imaging of patients with gastroenteropancreatic neuroendocrine neoplasms (GEP-NEN)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigshospitalet, Denmark
• Treatments: Fluorodeoxyglucose F18

Criteria

Inclusion Criteria:

• Histopathologically verified gastro-entero-pancreatic neuroendocrine neoplasm (GEP-NEN) or patients with unknown primary tumor with metastases with verified NEN positive histopathological examination suggesting GEP origin

• World Health Organization (WHO) Performance status 0-2

• Must be able to read and understand the patient information in Danish and to give informed consent

Exclusion Criteria:

• Pregnancy

• Breast-feeding

• Weights more than the maximum weight limit for the PET/CT bed of the scanner (140 kg)

• Uncontrolled diabetes

• Uncontrolled infection

• Exacerbation in autoimmune diseases

• Other active cancer disease

• Conditions or diseases (e.g. uncontrolled Parkinson's disease) making the patient unable to lie still in the scanner

• Severe claustrophobia

• Localized neuroendocrine neoplasms of the appendix, the rectum measuring < 1 cm, and ECL-omas of the stomach

• History of allergic reaction attributable to compounds of similar chemical or biologic com-position to 18FDG or 64Cu-DOTATATE