[68Ga]Ga-PentixaFor-PET Imaging for Staging of Marginal Zone Lymphoma
- Conditions
- Marginal Zone Lymphoma
- Interventions
- Drug: [18F]Fluorodeoxyglucose
- Registration Number
- NCT06125028
- Lead Sponsor
- Pentixapharm AG
- Brief Summary
This will be a pivotal prospective prospective, international, multi-center, comparative, randomized, cross-over, open-label lymphoma diagnostic trial to assess the diagnostic performance and safety of the positron emission tomography (PET) imaging agent \[68Ga\]Ga-PTF) , versus \[18F\]FDG PET/CT imaging, for staging of patients with confirmed marginal zone lymphoma exemplary for CXCR4-positive malignant lymphomas.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 148
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description [18F]FDG PET/CT [18F]Fluorodeoxyglucose \[18F\]FDG will be administered once intravenously according to the SMPC and PET/CT will be performed [68Ga]Ga-PTF PET/CT [68Ga]Ga-PentixaFor 150 (+/-50) MBq \[68Ga\]Ga-PTF will be administered intravenously and PET/CT will be performed
- Primary Outcome Measures
Name Time Method Specificity of [68Ga]Ga-PTF PET/CT imaging vs. [18F]FDG PET/CT imaging in tumor detection Through study completion, an average of 6 months Sensitivity of [68Ga]Ga-PTF PET/CT imaging vs. [18F]FDG PET/CT imaging in tumor detection Through study completion, an average of 6 months
- Secondary Outcome Measures
Name Time Method Proportion of patients with splenic MZL with additional or less lesions detected by each PET/CT imaging agent ([68Ga]Ga-PTF and [18F]FDG) compared to pre-PET conventional staging as assessed by questionnaires completed by the referring physicians Through study completion, an average of 6 months Inter-observer agreement of local and central assessment in terms of staging Through study completion, an average of 6 months Sensitivity of each PET/CT imaging agent in tumor detection on a patient-basis confirmed by SoT or surrogate SoT Through study completion, an average of 6 months Proportion of patients with additional or less lesions detected by each PET/CT imaging agent ([68Ga]Ga-PTF and [18F]FDG) compared to pre-PET conventional staging as assessed by questionnaires completed by the referring physicians Through study completion, an average of 6 months Proportion of patients with nodal MZL with a change in intended patient management due to additional or less lesions detected by each PET/CT imaging agent ([68Ga]Ga-PTF and [18F]FDG) as assessed by questionnaires completed by the referring physicians Through study completion, an average of 6 months Diagnostic performance, consisting of sensitivity and specificity, of each PET/CT imaging agent in tumor detection on a region-basis (eyes, ears, nose, throat, liver, spleen, gastrointestinal tract, bone marrow) confirmed by SoT or surrogate SoT Through study completion, an average of 6 months Positive and negative predictive values (PPV, NPV) of each PET/CT imaging agent to detect tumor on a patient-basis and lesion-basis Through study completion, an average of 6 months Inter-reader and intra-reader agreement for tumor detection of each PET/CT imaging agent on a lesion-basis and patient-basis Through study completion, an average of 6 months Frequency and Severity of Adverse Events for each PET/CT imaging agent Prior injection of each PET/CT imaging agent and after injection of each PET/CT imaging agent Target-to-background ratio (TBR) of each PET/CT imaging agent Through study completion, an average of 6 months Proportion of patients with a change in intended patient management due to additional or less lesions detected by each PET/CT imaging agent ([68Ga]Ga-PTF and [18F]FDG) as assessed by questionnaires completed by the referring physicians Through study completion, an average of 6 months Proportion of patients with nodal MZL with additional or less lesions detected by each PET/CT imaging agent ([68Ga]Ga-PTF and [18F]FDG) compared to pre-PET conventional staging as assessed by questionnaires completed by the referring physicians Through study completion, an average of 6 months Proportion of patients with additional or less lesions detected by each PET/CT imaging agent ([68Ga]Ga-PTF and [18F]FDG) compared to pre-PET conventional staging as assessed by questionnaires completed by an Independent Committee Through study completion, an average of 6 months Proportion of patients with extranodal MZL with additional or less lesions detected by each PET/CT imaging agent ([68Ga]Ga-PTF and [18F]FDG) compared to pre-PET conventional staging as assessed by questionnaires completed by the referring physicians Through study completion, an average of 6 months Detection rate of each PET/CT imaging agent to detect tumor on a patient-basis and lesion-basis confirmed by SoT or surrogate SoT Through study completion, an average of 6 months Reproducibility of [68Ga]Ga-PTF PET/CT imaging (reproducibility group) Through study completion, an average of 6 months Maximum standardized uptake value (SUVmax), SUVpeak and SUV mean of each PET/CT imaging agent Through study completion, an average of 6 months Contrast-to-noise ratio (CNR) of each PET/CT imaging agent Through study completion, an average of 6 months Signal-to-noise ratio (CNR) of each PET/CT imaging agent Through study completion, an average of 6 months Proportion of patients with extranodal MZL with a change in intended patient management due to additional or less lesions detected by each PET/CT imaging agent ([68Ga]Ga-PTF;[18F]FDG) as assessed by questionnaires completed by the referring physicians Through study completion, an average of 6 months Proportion of patients with splenic MZL with a change in intended patient management due to additional or less lesions detected by each PET/CT imaging agent ([68Ga]Ga-PTF and [18F]FDG) as assessed by questionnaires completed by the referring physicians Through study completion, an average of 6 months Clinical significance of abnormal results during physical examination Prior injection of each PET/CT imaging agent and after injection of each PET/CT imaging agent The safety and tolerability for each PET/CT imaging agent will be evaluated by the assessment of physical examination findings
QT interval findings/abnormalities Prior injection of each PET/CT imaging agent and after injection of each PET/CT imaging agent The safety and tolerability for each PET/CT imaging agent will be evaluated by the assessment of QT interval findings/abnormalities
Proportion of patients with additional or less tumoral lesions detected by [68Ga]Ga-PTF PET/CT imaging compared to [18F]FDG PET/CT imaging Through study completion, an average of 6 months Blood pressure (systolic and diastolic) Prior injection of each PET/CT imaging agent and after injection of each PET/CT imaging agent The safety and tolerability for each PET/CT imaging agent will be evaluated by the assessment of blood pressure (systolic and diastolic)
Heart or pulse rate Prior injection of each PET/CT imaging agent and after injection of each PET/CT imaging agent The safety and tolerability for each PET/CT imaging agent will be evaluated by the assessment of heart or pulse rate
RR interval findings/abnormalities Prior injection of each PET/CT imaging agent and after injection of each PET/CT imaging agent The safety and tolerability for each PET/CT imaging agent will be evaluated by the assessment of findings/abnormalities in the RR interval
PQ interval findings/abnormalities Prior injection of each PET/CT imaging agent and after injection of each PET/CT imaging agent The safety and tolerability for each PET/CT imaging agent will be evaluated by the assessment of PQ interval findings/abnormalities
QRS complex findings/abnormalities Prior injection of each PET/CT imaging agent and after injection of each PET/CT imaging agent The safety and tolerability for each PET/CT imaging agent will be evaluated by the assessment of QRS complex findings/abnormalities
QTc interval findings/abnormalities Prior injection of each PET/CT imaging agent and after injection of each PET/CT imaging agent The safety and tolerability for each PET/CT imaging agent will be evaluated by the assessment of QTc interval findings/abnormalities
Frequency and kind of adverse effects present at the injection site 2-3 hours after injection of each PET/CT imaging agent The safety and tolerability for each PET/CT imaging agent will be evaluated by the assessment of the injection site status (which kind of adverse effects have appeared) after the injection of each PET/CT imaging compound
Weight Prior injection of each PET/CT imaging agent and after injection of each PET/CT imaging agent The safety and tolerability for each PET/CT imaging agent will be evaluated by the assessment of patient weight
Trial Locations
- Locations (12)
Medizinische Universität Innsbruck
🇦🇹Innsbruck, Austria
CHU de Bordeaux
🇫🇷Bordeaux, France
CHU La Timone
🇫🇷Marseille, France
CHU de Nantes
🇫🇷Nantes, France
Hôpital Cochin
🇫🇷Paris, France
Universitätsklinikum Essen
🇩🇪Essen, Germany
Universitätsklinikum Würzburg
🇩🇪Würzburg, Germany
IRCCS Azienda Ospedaliero-Universitaria di Bologna
🇮🇹Bologna, Italy
L'IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l
🇮🇹Meldola, Italy
Ospedale San Raffaele S.r.l.
🇮🇹Milano, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
🇮🇹Rome, Italy
Clinica Universidad de Navarra
🇪🇸Pamplona, Navarra, Spain