E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10062476 |
E.1.2 | Term | Neuroendocrine tumor |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10057270 |
E.1.2 | Term | Neuroendocrine carcinoma |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10068916 |
E.1.2 | Term | Pancreatic neuroendocrine tumor metastatic |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10071542 |
E.1.2 | Term | Neuroendocrine carcinoma metastatic |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10077560 |
E.1.2 | Term | Gastroenteropancreatic neuroendocrine tumor disease |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10067518 |
E.1.2 | Term | Pancreatic neuroendocrine tumor |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 24.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10085846 |
E.1.2 | Term | Duodenal neuroendocrine tumor |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 24.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10085958 |
E.1.2 | Term | Small intestine neuroendocrine tumor |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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.
|
|
E.2.2 | Secondary objectives of the trial |
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. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
|
|
E.4 | Principal 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
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Overall survival (OS) and progression free survival (PFS). |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
12 months following the last patient's last visit. |
|
E.5.2 | 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. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
When data from dual 18FDG and 64Cu-DOTATATE PET/CT are available from 50 patients. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Both routine PET/CTs and trial-related PET/CTs are included in the study |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
End-of-trial is defined 12 months following the last patient's last visit. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |