Dual 64Cu-DOTATATE and 18F-FDG PET/CT Imaging of Patients With Neuroendocrine Neoplasms
Launched by RIGSHOSPITALET, DENMARK · Jan 24, 2023
Trial Information
Current as of June 26, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
Patients with neuroendocrine neoplasms (NEN) represent a heterogeneous disease group with variable prognosis. NEN most frequently arise from the gastrointestinal tract or the pancreas; collectively termed GEP-NEN. Grading of GEP-NEN is based on tumor proliferation index (Ki-67) from biopsies or surgical resection specimens into: low grade G1 neuroendocrine tumor (NET) (Ki-67\<3%), intermediate grade G2 NET (Ki-67 3-20%) and high grade NEN (Ki-67%\>20). High grade NENs are further categorized according to tissue morphology into well-differentiated G3 neuroendocrine tumors (NET) and poorly di...
Gender
ALL
Eligibility 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
About Rigshospitalet, Denmark
Rigshospitalet, located in Copenhagen, Denmark, is one of the leading hospitals in Scandinavia and a prominent center for clinical research and innovation. As a key academic institution affiliated with the University of Copenhagen, Rigshospitalet is dedicated to advancing healthcare through rigorous clinical trials and groundbreaking research across various medical disciplines. The hospital’s commitment to excellence is reflected in its multidisciplinary approach, collaboration with international research networks, and focus on improving patient outcomes through evidence-based practices. With state-of-the-art facilities and a team of highly qualified professionals, Rigshospitalet plays a crucial role in translating scientific discoveries into effective treatments and therapies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Copenhagen, , Denmark
Patients applied
Trial Officials
Andreas Kjaer, MD
Study Director
Rigshospitalet, Denmark
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials