E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with imaging suspected breast cancer (BI-RADS 4&5 on conventional imaging, e.g. mammography and ultrasound). |
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E.1.1.1 | Medical condition in easily understood language |
Patients with suspected breast cancer. |
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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 | 20.0 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10006291 |
E.1.2 | Term | Breast neoplasms malignant and unspecified (incl nipple) |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10006288 |
E.1.2 | Term | Breast neoplasms benign (incl nipple) |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 | 10029815 |
E.1.2 | Term | Nuclear magnetic resonance imaging |
E.1.2 | System Organ Class | 10022891 - Investigations |
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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 | 10036223 |
E.1.2 | Term | Positron emission tomography |
E.1.2 | System Organ Class | 10022891 - Investigations |
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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 |
To investigate whether multi-parametric simultaneous PET-MRI with 18F-methylcholine will improve the detection and characterization of mammographically and sonographically suspicious breast lesions. |
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E.2.2 | Secondary objectives of the trial |
To investigate whether multi-parametric simultaneous PET-MRI with 18F-methylcholine will improve the diagnosis of disease extent in patients with breast cancer. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Breast lesion classified as suspicious on conventional imaging (ACR BI-RADS 4 or 5); • Age > 18 years; • No previous biopsy in the site of the lesion at the time of PET-MRI; • Following histopathological confirmation of the lesion by biopsy or surgery. |
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E.4 | Principal exclusion criteria |
• Unstable or non-compliant patients; • Pregnant or breast-feeding patients; • Radiation therapy within the last six months or surgical interventions less than 12 weeks before PET-MRI examination; • Known contraindication to the intravenous administration of MR contrast agents or MRI examination; • Known contraindication to the intravenous administration of 18F-methylcholine; • Acute or chronic renal insufficiency; • Pre- or post-transplant patients. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Diagnostic performance indices for distinguishing benign from malignant tissues (Area Under the Receiver Operating Characteristics Curve - AUC, Sensitivity, Specificity) calculated in a patient-, region- and lesion-wise manner. All diagnostic performance indices will be calculated for single and combined parameters. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Each diagnostic test will be immediately classified as "positive" or "negative". After the reference standard (biopsy or open surgery with subsequent histopathological evaluation) is present, true positives (test positive, reference standard positive), false positives (test positive, reference standard negative), false negatives (test negative, reference standard positive) and true negatives (test negative, reference standard negative) will be assigned. |
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E.5.2 | Secondary end point(s) |
Diagnostic performance indices (as defined above) for correct versus incorrect staging (estimation of disease extent). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Same as for primary endpoint. |
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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 | 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 | 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 | Yes |
E.8.2.3.1 | Comparator description |
Multiparametric Magnetic Resonance Imaging |
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E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |