Combined 64Cu-DOTATATE and 18F-FDG PET/CT Imaging in Patients with Neuroendocrine Tumors

Phase 1

• Conditions: euroendocrine neoplasms; MedDRA version: 21.0Level: LLTClassification code 10062476Term: Neuroendocrine tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10057270Term: Neuroendocrine carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: LLTClassification code 10068916Term: Pancreatic neuroendocrine tumor metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10071542Term: Neuroendocrine carcinoma metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: LLTClassification code 10077560Term: Gastroenteropancreatic neuroendocrine tumor diseaseSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: LLTClassification code 10067518Term: Pancreatic neuroendocrine tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 24.1Level: LLTClassification code 10085846Term: Duodenal neuroendocrine tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 24.1Level: LLTClassification code 10085958Term: Small intestine neuroendocrine tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2021-005919-30-DK
• Lead Sponsor: Department of Clinical Physiology and Nuclear Medicine, Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-15
• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1) Age of or above 18 years
2) Histopathologically verified gastro-pancreatic neuroendocrine neoplasm
3) Patients with unknown primary tumor with metastases with verified neuroendocrine neoplasm positive histopathological examination suggesting gastro-pancreatic origin
4) Must be able to read and understand the patient information in Danish and to give informed consent
5) WHO Performance status 0-2

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate if Cox proportional hazard models based on tumor standardized uptake values and tumor volume measurements from 18FDG PET/CT and 64Cu-DOTATATE PET/CT are both prognostic of progression free survival and overall survival; and if Cox proportional hazard models based on tumor standardized uptake values and tumor volume measurements derived from combined 18FDG and 64Cu-DOTATATE PET/CT provide stronger prognostic information than 18FDG PET/CT or 64Cu-DOTATATE PET/CT alone.<br>;Secondary Objective: To investigate if standardized uptake values from manually depicted regions-of-interests, semi-automatic segmentation methods, and machine-learning based algorithms on 64Cu-DOTATATE PET correlate inversely with corresponding tumor SUVs on 18FDG PET.;Primary end point(s): Overall survival (OS) and progression free survival (PFS). ;Timepoint(s) of evaluation of this end point: 12 months following the last patient's last visit.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The correlation between of 18FDG and 64Cu-DOTATATE standardized uptake values from tumors and healthy tissues derived from manually depicted regions-of-interests, semi-automatic segmentation methods and machine-learning based algorithms.;Timepoint(s) of evaluation of this end point: When data from dual 18FDG and 64Cu-DOTATATE PET/CT are available from 50 patients.