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 |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10005004 |
E.1.2 | Term | Bladder cancer NOS |
E.1.2 | System Organ Class | 100000004864 |
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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 |
The sensitivity and specificity of 68Ga-NOTA-AE105 PET/CT and FDG PET/MR for detection of regional lymph node metastases will be tested by observer-blinded readings (two separate teams) and compared to diagnostic performance of conventional preoperative procedure. The reference test will be histopathology of lymph nodes obtained by operative lymph node dissection based on 6 regions. The suspected lymph nodes will be assigned to 6 regions based on the images. During the following operation the lymph nodes will be removed and analysed in each of these regions. |
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E.2.2 | Secondary objectives of the trial |
Number of lymph node metastases in each of the 6 lymph node regions. Detection of distant metastases. For possible detected distant metastases biopsy/follow up imaging will be used as reference test. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Biopsy-verified urinary bladder cancer The participants must be capable of understanding and giving full informed written consent age above 18 years |
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E.4 | Principal exclusion criteria |
Pregnancy Lactation/breast feeding Age above 85 years old Weight above 140 kg Treatment with neoadjuvant chemotherapy Known allergy towards 68Ga-NOTA-AE105 Other malignant disease within last 5 years, except for non-melanoma skin cancer |
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E.5 End points |
E.5.1 | Primary end point(s) |
Detection of lymph node metastases in each of 6 regions by the two imaging modalities: FDG PET/MR and 68Ga-NOTA-AE105 PET/CT |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Evaluation of the primary endpoints from PET scans (FDG and 68Ga-NOTA-AE-105) performed within 1 hour post injection of FDG/68Ga-NOTA-AE105 |
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E.5.2 | Secondary end point(s) |
Number of lymph node metastases in each of 6 regions Distant metastases |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Evaluation of the secondary endpoints from PET scans (FDG and 68Ga-NOTA-AE-105) performed within 1 hour post injection of FDG/68Ga-NOTA-AE105 |
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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 | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
diagnostic performance (sensitivity/specificity, NPV, PPV) of FDG PET/MR and uPAR PET/CT |
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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 | 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 | 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
| 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
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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 | |
E.8.9.1 | In the Member State concerned days | |