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

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

NCT ID: NCT05709171

Condition: GEP-NET
Neuroendocrine Tumors
Neuroendocrine Carcinoma
Neuroendocrine Carcinoma Metastatic

Conditions: Official terms:
Carcinoma
Neoplasms
Neuroendocrine Tumors
Carcinoma, Neuroendocrine
Fluorodeoxyglucose F18

Study type: Interventional

Study phase: Phase 2

Overall status: Enrolling by invitation

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: 18F-FDG
Description: PET/CT scan approximately 60 min after injection of 18F-FDG
Arm group label: Experimental

Other name: 18F-fluorodeoxyglucose

Other name: fluorodeoxyglucose-F-18

Other name: [18F]F-FDG

Intervention type: Drug
Intervention name: 64Cu-Dotatate
Description: PET/CT scan approximately 60 min after injection of 64Cu-Dotatate
Arm group label: Experimental

Other name: Copper (64Cu) oxodotreotide

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)

Detailed description: 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 differentiated neuroendocrine carcinomas (NEC). A common feature of most NETs is the overexpression of somatostatin receptors (SSR) on the tumor cell surface. Whole-body PET/CT imaging with radiolabelled SSR-targeted tracers, e.g. 64Cu-DOTATATE, plays a key role in diagnosis, staging, treatment selection and response evaluation of patients with NET. Measurements of 64Cu-DOTATATE tumor standardized uptake values (SUV) and tumor volume on PET/CT provide prognostic value for patients with NET. Patients with high grade NEN often have lower SSR expression and SSR PET/CT is infrequently routinely performed in these patients. However, we expect that the SUV and tumor volume from 64Cu-DOTATATE PET/CT also holds prognostic information for patients with high grade NEN and that some patients may prove eligible for PRRT based on the scans. 18F-FDG PET/CT imaging is widely used in cancers, but is routinely primarily reserved for patients with high grade NEN. However, 18F-FDG PET/CT also holds prognostic information for patients with lower grade NET. By combining 64Cu-DOTATATE PET/CT and 18F-FDG PET/CT imaging, we expect to obtain complementary prognostic information for patients with GEP-NEN of all grades. In this clinical trial, we will therefore investigate and compare the tumor phenotypes found on 64Cu-DOTATATE PET/CT and 18FDG PET/CT performed within 4 weeks in patients with GEP-NET G1-3 and GEP-NEC. The aim of the trial is to establish prognostic models for progression-free-survival (PSF) and overall survival (OS) including tumor status (positive/negative), SUV measurements, and tumor volume derived from the dual 64Cu-DOTATATE PET/CT and 18FDG PET/CT scans.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Rigshospitalet

Address:
City: Copenhagen
Zip: 2100
Country: Denmark

Start date: January 17, 2023

Completion date: January 1, 2026

Lead sponsor:
Agency: Rigshospitalet, Denmark
Agency class: Other

Source: Rigshospitalet, Denmark

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05709171