E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
renal cell cancer (RCC) |
cancer à cellules rénales (CCR) |
|
E.1.1.1 | Medical condition in easily understood language |
renal cell cancer (RCC) |
cancer à cellules rénales (CCR) |
|
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 |
to prospectively evaluate the interest of 68Ga-PSMA PET-CT in the detection and characterization of metastatic lesions compared to baseline examinations (cerebral and thoracoabdominopelvic CT and bone scintigraphy) during the initial extension patients with clinically non-metastatic advanced renal cell cancer (RCC) |
évaluer prospectivement l’intérêt de la TEP-TDM au 68Ga-PSMA dans la détection et la caractérisation des lésions métastatiques par rapport aux examens de référence (TDM cérébral et thoraco-abdomino-pelvien et scintigraphie osseuse) lors du bilan d'extension initial des patients atteints d'un cancer à cellules rénales (CCR) avancé cliniquement non métastatique |
|
E.2.2 | Secondary objectives of the trial |
- To evaluate the interest of 68Ga-PSMA PET-CT in the extension assessment in specific subgroups (subtypes and histological grades, ...).
- To estimate the diagnostic performance of PET-CT at 68Ga-PSMA in the initial extension balance of advanced RCCs compared to the current standard balance.
- To assess the impact of PET-CT 68Ga- PSMA in therapeutic intent and monitoring of patients with RCC.
- To study the diagnostic performance of 68Ga-PSMA PET-CT on primary renal tumor when it is still in place. |
- Evaluer l’intérêt de la TEP-TDM au 68Ga-PSMA dans le bilan d’extension dans des sous-groupes spécifiques (sous types et grades histologiques,...).
- Estimer les performances diagnostiques de la TEP-TDM au 68Ga-PSMA dans le bilan d’extension initial des CCR avancés comparativement au bilan standard actuel.
- Evaluer l'impact de la TEP-TDM au 68Ga- PSMA dans l'intention thérapeutique et le suivi des patients atteints d’un CCR.
- Etudier les performances diagnostiques de la TEP-TDM au 68Ga-PSMA sur la tumeur rénale primitive lorsque celle-ci est encore en place. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Age ≥ 18 years,
• newly diagnosed patient for localized RCC intermediate or high risk (prognostic system UISS) or metastatic kidney cancer (M1 according to the TNM staging) with histological evidence (biopsy or surgical removal of part).
• Recent conventional imaging review (from 1 month maximum on PET day at 68Ga-PSMA):
- cerebral CT, chest and abdominopelvic CT with iodine injection comprising an arterial and portal and late time;
- bone scintigraphy. |
• Age ≥ 18 ans,
• Patient nouvellement diagnostiqué pour un CCR localisé de risque intermédiaire ou haut (système pronostique UISS) ou un cancer du rein métastatique (M1 selon la stadification TNM) avec preuve histologique (biopsie ou pièce d’exérèse chirurgicale).
• Bilan d’imagerie conventionnelle récent (datant de 1 mois maximum le jour de la TEP au 68Ga-PSMA) :
- TDM cérébrale, TDM thoracique et abdomino-pelvienne avec injection d’iode comprenant un temps artériel puis portal et tardif ;
- Scintigraphie osseuse ; |
|
E.4 | Principal exclusion criteria |
• Pregnant or lactating woman;
• History of other evolutionary neoplasia known in the previous 2 years |
• Femme enceinte ou allaitante ;
• Antécédent d’autre néoplasie évolutive connue au cours des 2 années précédentes |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The interest of PET-CT at 68Ga-PSMA will be defined by the number of patients for whom:
• at least one lesion classified as 'malignant' in PET is not seen or classified as 'benign' by reference imaging,
or
• at least one lesion classified as 'malignant' by reference imaging is excluded (classified as 'benign') in PET. |
L’intérêt de la TEP-TDM au 68Ga-PSMA sera défini par le nombre de patients pour lesquels :
• au moins une lésion classée ‘maligne’ en TEP est non vue ou classée ‘bénigne’ par l'imagerie de référence,
ou
• au moins une lésion classée ‘maligne’ par l'imagerie de référence est écartée (classée ‘bénigne') en TEP. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
• The interest of 68Ga-PSMA PET-CT will be established according to the following factors: histological subtype, histological grade, TNM stage 2009, ECOG, biology, size of metastatic lesions, classification, anatomical location of metastatic lesions.
• Diagnostic performance of 68Ga-PSMA PET-CT (sensitivity, specificity, negative and positive predictive values per patient and lesion) and comparison to the diagnostic performance of currently recommended reference examinations.
• Comparison between the therapeutic intention (surgery, surveillance, radiotherapy, medical treatment ...) before the PET and the final therapeutic decision, description of the rate and the nature of the possible changes of care.
• Qualitative visual analysis of the fixation and semi-quantitative analysis in 68Ga-PSMA PET-CT of the primary renal tumor if it is still in place. |
•L’intérêt de la TEP-TDM au 68Ga-PSMA sera établi en fonction des facteurs suivants: sous-type histologique, grade histologique, stade TNM 2009, ECOG, biologie, taille des lésions métastatiques, classification, localisation anatomique des lésions métastatiques.
•Performances diagnostiques de la TEP-TDM au 68Ga-PSMA (sensibilité, spécificité, valeurs prédictives négative et positive; par patient et par lésion) et comparaison aux performances diagnostiques des examens de référence actuellement recommandés.
•Comparaison entre l'intention thérapeutique (chirurgie, surveillance, radiothérapie, traitement médical…) avant la TEP et la décision thérapeutique finale, description du taux et de la nature des éventuels changements de prise en charge.
•Analyse visuelle qualitative de la fixation et analyse semi quantitative en TEP-TDM au 68Ga-PSMA de la tumeur rénale primitive si celle-ci est encore en place. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | 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
| 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
|
LVLS |
dernière visite du dernier sujet inclus (DVDS) |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |