E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Colon and gastric cancer patients |
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E.1.1.1 | Medical condition in easily understood language |
Bowel and gastric cancer patients |
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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 |
Assess the feasibility of [18F]-PSMA-1007 PET/CT imaging to detect primary colon and gastric cancer. |
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E.2.2 | Secondary objectives of the trial |
Assess association between the in vivo [18F]-PSMA-1007 PET/CT-imaging uptake in the tumor and histopathologic evidence of tumor tissue and PSMA expression determined on the resection specimen.
Assess the agreement between different preoperative imaging modalities (e.g. [18F]-PSMA-1007 PET/CT-scan, [18F]-FDG-PET/CT, MR imaging, CT imaging, gastroscopy, colonoscopy).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Patients aged 18 years or older. • Diagnosis of primary T3-4N0-2M0-1 colorectal adenocarcinoma (cohort 1) or primary T3-4N0-2M0 gastric carcinoma (cohort 2) and eligible for surgery. • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial. • Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
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E.4 | Principal exclusion criteria |
• Any condition that in the opinion of the investigator could potentially jeopardize the health status of the patient. • Women who are pregnant and/or or lactating. • Diabetes Mellitus • Medical or psychiatric conditions that compromise the patient’s ability to give informed consent. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. • Prior radiotherapy to the abdomen (cohort 1 and 2) and/or thorax (cohort 2). • Unacceptable known (clinically significant) cardiovascular or pulmonary disease, renal or liver dysfunction. • Known hypersensitivity to drugs comparative to PSMA-1007, or any of their excipients or to any component of [18F]-PSMA-1007. • Inability to undergo PET/CT scanning (e.g. claustrophobia, weight limits or inability to tolerate lying for the duration of a PET/CT scan (~30 min). • Inability to undergo routine MRI or CT scans as part of the diagnostic work up.
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E.5 End points |
E.5.1 | Primary end point(s) |
Quantification of the accumulation of [18F]-PSMA-1007 (by using TBR, SUV and/or RUV) in the primary tumor on PET/CT. Tumor imaging is feasible (positive) at a TBR ≥ 2.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At early stopping rule and end of study |
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E.5.2 | Secondary end point(s) |
Assess agreement between PET/CT-imaging signal in the cancer and histopathologic evidence of cancer and PSMA expression by the cancer cells or endothelial cells of newly formed capillaries.
Assess the agreement between different preoperative imaging modalities (e.g. [18F]-PSMA-1007 PET/CT-scan, [18F]-FDG-PET/CT, MR imaging, CT imaging, gastroscopy, colonoscopy). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At early stopping rule and end of study |
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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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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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
| 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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In case of enacting of the early stopping rule, otherwise after last subject inclusion. |
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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 | |