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 |
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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 | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033575 |
E.1.2 | Term | Pancreas cancer |
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 |
Proof of concept study for application of hyperpolarized [1-13C]Pyruvate in magnetic resonance spectroscopy for early in vivo detection of therapeutic effects in treatment of pancreatic cancer |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives of the trial: To establish whether the sensitivity of MR-hyperpolarized [1-13C]Pyruvate based MR-spectroscopy is high enough for future studies of surgical intervention versus cytotoxic treatment. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria • Patients with inoperable (metastatic, locally advanced or localised) histologically or cytologically verified pancreatic adenocarcinoma. • Scheduled for first-line palliative chemotherapy of any type. • At least 18 years of age. • WHO performance status 0-2. • Measurable or unmeasurable disease. • Adequate hematologic and organ function, i.e. ANC at least 1.5 Platlet count >100 Se bilirubin <1.5 UNL ASAT, ALAT and AP up to 2.5 x UNL, up to 5 x UNL with liver metastases Se creatinine up to 1.5 x UNL or creatinine clearance at least 30 ml/min INR and aPTT at most 1.5 x UNL, except for patients on AK treatment • Women who are not postmenopausal or surgically sterile must have a negative serum pregnancy test. Safe contraception should be used throughout the study for all other patients. • Danish speaking • Able and willing to comply after informed consent |
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E.4 | Principal exclusion criteria |
Patients in whom treatment is curatively intended, e.g. patients scheduled for preoperative treatment of marginally resectable disease • Contraindications to contrast enhanced MRI • Contraindication to contrast enhanced CT • Not able or willing to receive chemotherapy • Patients not willing to participate |
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E.5 End points |
E.5.1 | Primary end point(s) |
The scanning program is terminated after 15 complete hyperpolarization scanning procedures in patients with c. pancreatitis - or unacceptable side effects appears |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After the first five scanning's to evaluate the applied MR- hyperpolarization scanning sequences |
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E.5.2 | Secondary end point(s) |
After subsequent 10 complete patient scanning's
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
After completing all 15 hyperpolarization scanning's |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
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) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
Exploratory feasibility study |
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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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a patients involvement ends after the one hyperpolarisation scanning and blood sample one week later. The hyperpolarization data will be related to the disease status in the subsequent half year. The full study is expected to last 20 months |
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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 | 8 |
E.8.9.1 | In the Member State concerned days | |