- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02505685
Dynamic PET CT as a Tool for Treatment Efficacy Monitoring in Lung Cancer
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Background:
Lung cancer is a devastating disease in which the response for first line therapy is only 30%. Evaluating response is performed normally by a CT or PET-CT scans after 2-3 cycles of therapy, thus, lack of response is been evaluated only after the patient has been treated following significant amount of therapy, which is inefficient in 70% of cases.
Therefore, there is an urgent need to develop tools that might predict response to therapy during the early course of therapy; Most valuable will be before or after the first cycle of therapy. For that reason, the investigators aim in this study to evaluate the use of Dynamic PET-CT as a tool to assess disease response to anti-cancer therapy in Lung Cancer patients.
Objectives:
- To assess the feasibility of baseline Dynamic PET-CT as a tool for assessing response for anti-cancer therapy in Lung Cancer patients.
- To predict early response to treatment as soon as after 1 cycle of therapy by dynamic and static PET-CT.
- To correlate Dynamic PET-CT with survival/disease free survival
Method:
200 advanced lung cancer patients will be enrolled over 3 years in a single institute, single arm study at Rabin Medical Center, Beilinson Hospital.
Patients will be evaluated by a Dynamic PET-CT protocol: before initiation of therapy, 7-14 days after the first therapy cycle, 3 months after initiation of therapy and 6 months after the first therapy cycle. In addition, non-invasive biomarkers that are routinely measured including protein markers (CEA- Carcinoembryonic Antigen, CYFRA21- Cytokeratin 19 Fragment, NSE- Neuron Specific Enolase) will be assessed in this trial.
Disease response will be evaluated by Response Evaluation Criteria In Solid Tumors (RECIST criteria).
Additional PET-CT will not increase radiation dose significantly. The mean estimated radiation dose for a limited CT of the chest is about 14 mSv (i.e., 7mSv for limited diagnostic CT and FDG ([18F]-fluorodeoxyglucose), each). The dynamic stage will add radiation dose of about 0.3mSv. Of note, the significance of adding radiation dose is less of importance with regard to treatment of patients with aggressive cancer.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
-
-
-
Petach Tikva, Israël, 49100
- Rabin Medical Center
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Age > 18 years.
- Lung cancer, stage 4
- Patients are planned to be treated by a systemic anti-cancer therapy.
- A define lesion for imaging.
- Able and willing to sign an informed consent form.
- First line therapy or at least 6 weeks after previous line of therapy
Exclusion Criteria:
- Pregnant or lactating women.
- Anti cancer therapy within the last 6 weeks before enrollment.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
---|
Lung cancer
People that were diagnosed with advanced lung cancer.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Compare baseline PET-CT with PET-CT after 7-14 days.
Délai: 12 months
|
12 months
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Evaluate disease-free survival (DFS) in lung cancer by using dynamic PET-CT.
Délai: 12 months
|
12 months
|
Evaluate overall survival rate (OS) in lung cancer by using dynamic PET-CT.
Délai: 12 months
|
12 months
|
Measuring response to treatment by PET-CT.
Délai: 12 months
|
12 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Nir Peled, MD PhD FCCP, Rabin Medical Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 0618-14-RMC
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .