E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Neuroendocrine tumors (NET) |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
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 |
Demonstrate the non-inferior diagnostic performance of Al18F-NOTA-octreotide PET imaging in comparison with the current golden standard, 68Ga-DOTA-SSA PET, in NET patients |
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E.2.2 | Secondary objectives of the trial |
- Perform a lesion detection rate analysis on the organ level - Perform a semi-quantitative analysis of radiotracer uptake in lesions - Evaluate the clinical impact per patient - Evaluate the influence of the specific 68Ga-DOTA-SSA used in routine clinical care - Perform a sub analysis according to tumor grade - Perform an inter-observer agreement analysis for image quality and lesion conspicuity - Evaluate the whole-body MRI correlate of the lesions detected by the PET scans |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Subject is aged over 18 years - Signed Informed Consent - Subject is diagnosed with a histologically and/or cytologically confirmed neuroendocrine tumor of all grades of gastroenteropancreatic, pulmonary, neural crest or unknown primary origin - Subject should have at least one known tumoral lesion below the level of the submandibular and parotid glands with either a minimum size of 1 cm in at least one dimension on morphological imaging (CT, MRI, ultrasound), or a maximal standardized uptake value (SUVmax) of at least 10 on 68Ga-DOTA-SSA PET, in both cases performed within 4 months prior to study scan. A positive lesion is defined as a volume of increased tracer uptake compared to background, deemed to be caused by the presence of NET cells, and that is unlikely to be attributed to physiological or benign etiology (e.g. inflammation, blood pool retention, excretion, etc.) - Subject should have a routine clinical 68Ga-DOTA-SSA PET/CT performed within three months prior to the study scan or scheduled within three months after the study scan - Female subjects should be (a) post-menopausal, or (b) surgically sterile, or (c) using effective contraceptive with negative pregnancy test |
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E.4 | Principal exclusion criteria |
Part A and B: - Subject has a previous or ongoing recurrent or chronic disease, other than a neuroendocrine tumor, at high risk to interfere with the performance or evaluation of the trial according to the judgement of the investigator - Subject has had exposure to ionizing radiation (> 1 mSv) in other research studies within the last 12 months - Subject has recently (< 30 days or 5 times the plasma half-life of the investigated drug, whichever is longest) participated or is simultaneously participating in another prospective interventional clinical trial - Subject is unwilling to avoid unusual, unaccustomed, or strenuous physical activity (i.e. weight lifting, running, bicycling) beginning 4 days prior to tracer injection up to 1 day after tracer injection - Subject is potentially pregnant (urinary hCG test can be performed in case of doubt) or is breast-feeding - Subject is unwilling or unable to perform all of the study procedures, or is considered unsuitable in any way by the principal investigator - Subject does not understand the study procedure - Subject is mentally or legally incapacitated
Only for part B: - Subject has a contra-indication for MR scanning - Subject suffers from claustrophobia or cannot tolerate confinement during PET/MR scanning - Subject has an impaired renal function: estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m² (the last known value may not date from more than 3 months prior to the study PET/MR; if not available a blood analysis may be performed as part of the trial) - Subject suffers from diseases for which butylhyoscine bromide (Buscopan®) is contra-indicated: glaucoma, paralytic ileus, severe colitis ulcerosa or myasthenia gravis |
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E.5 End points |
E.5.1 | Primary end point(s) |
Confirmation that the diagnostic performance of Al18F-NOTA-octreotide PET is equivalent or superior to 68Ga-DOTA-SSA PET (only for part A of the trial) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After the PET/CT scans of the 75 patients in part A of the trial. Interim analysis after the PET/CT scans of the first 20 patients in part A of the trial. |
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E.5.2 | Secondary end point(s) |
1. Lesion detection rate analysis on the organ level 2. Semi-quantitative analysis of radiotracer uptake in lesions 3. Evaluate the clinical impact per patient (only part A of the trial) 4. Evaluate the influence of the specific 68Ga-DOTA-SSA used in routine clinical care 5. Sub analysis according to tumor grade 6. Inter-observer agreement analysis for image quality and lesion conspicuity (part A and part B will be treated as separate entities) 7. Evaluate the whole-body MRI correlate of the lesions detected by the PET scans (only part B of the trial) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. After the PET scans of all patients (part A and B) 2. After the PET scans of all patients (part A and B) 3. After the PET/CT scans of the 75 patients in part A of the trial 4. After the PET scans of all patients (part A and B) 5. After the PET scans of all patients (part A and B) 6. After the PET scans of all patients (part A and B) 7. After the PET/MR scans of the 10 to 20 patients in part B of the trial |
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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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
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 | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
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
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Last study visit of the last subject undergoing the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |