E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patient suffering from colorectal or pancreatic adenocarcinoma. |
Patienten met een colorectaal of pancreas carcinoom. |
|
E.1.1.1 | Medical condition in easily understood language |
Patients suffering from colorectal and pancreatic cancer. |
Patienten met darm of alvleesklierkanker. |
|
E.1.1.2 | Therapeutic area | Not possible to specify |
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 |
Assess feasibility and sensitivity of imaging tumor angiogenesis in PDAC and colorectal adenocarcinoma, using 18F-Fluciclatide. When successful, the data of this study will allow for a larger trial. |
Evalueren van de toepasselijkheid en sensitiviteit van tumor angiogenese beeldvorming bij colorectaal en pancreas carcinoom patienten, door middel van 18F-Fluciclatide. Daarnaast zal de mogelijkheid tot tumor response bepaling worden onderzocht. |
|
E.2.2 | Secondary objectives of the trial |
To define the most optimal PET acquisition time interval after i.v. administration of 18F-Fluciclatide PET/CT; Assess the feasibility of monitoring tumor response after neoadjuvant therapy will be assessed. To validate 18F-Fluciclatide as a clinical marker of angiogenesis by immunohistochemistry assessment of angiogenesis in PDAC and colorectal adenocarcinoma resection specimens. |
Optimale tijd van acquisitie bepalen voor 18F-Fluciclatide. Evalueren of het monitoren van tumor response mogelijk is met 18F-Fluciclatide. Valideren van 18F-Fluciclatide als klinische marker van angiogenese door middel van immunohistochemie. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Biopsy proven primary colorectal adenocarcinoma or suspected pancreatic ductal adenocarcinoma, as agreed on by multidisciplinary team; No prior chemo(radio)therapy in rectal cancer patients. Patients treated in the LUMC. Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations. |
Primair colorectaal adenocarcinoom of verdacht pancreas adenocarcinoom. Geen eerdere chemo(radio)therapie in rectum carcinoom patienten. Patient wordt behandeld in het LUMC. Voorafgaand aan patient registratie, informed consent moet getekend zijn zoals beschreven in ICH/GCP en nationale richtlijnen. |
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E.4 | Principal exclusion criteria |
Contraindication for PET (pregnancy, breast-feeding and severe claustrophobia); Impaired renal function (creatinine clearance < 60 mL/min according to the Cockcroft-Gault equation or ureum < 2x ULN (Upper limit of normal); Impaired liver function (ALAT, ASAT > 3 ULN or total bilirubin >2x ULN); Known allergy to pABA (p-aminobenzoate sodium salt); Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; Inability to tolerate lying supine for the duration of a PET/CT examination (~30min). |
Contraindicatie voor PET (zwanger, borstvoeding en ernstige claustrofobie). Slechte nierfunctie (kreatinine klaring <60 mL/min en ureum <2x upper limit of normal). Slechte leverfunctie (ALAT, ASAT >3x upper limit of normal of totaal bilirubine >2x upper limit of normal). Allergie voor pABA (p-aminobenzoate sodium salt) Psychologische, familiaire, sociologische of geografische conditie die mogelijk deelname aan studie kan verhinderen. Onvermogen om in rugligging te verkeren voor 30 minuten. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Sensitivity of 18F-Fluciclatide. |
Sensitiviteit van 18F-Fluciclatide. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
After first 5 patients and at the end of the trial. |
Na de eerste 5 patienten en aan het einde van de studie. |
|
E.5.2 | Secondary end point(s) |
Optimal time of acquisition Percentage difference in SUV before and after neoadjuvant treatment Immunohistochemical overlap with imaging findings. |
Optimale tijdpunt voor acquisitie. Percentage verschil in SUV voor en na neoadjuvante therapie Overlap van immunohistochemie en beeldvorming. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
End of trial. |
End of 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 | Yes |
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 | 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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | |
E.8.9.2 | In all countries concerned by the trial years | 1 |