Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, B-Cell, Marginal Zone

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Marginal Zone Lymphoma

Oculocerebral Syndrome With Hypopigmentation

B-cell Lymphoma

All Drugs and Chemicals

Fluorodeoxyglucose F18

Radiopharmaceuticals

150 (+/-50) MBq \[68Ga\]Ga-PTF will be administered intravenously and PET/CT will be performed

\[18F\]FDG will be administered once intravenously according to the SMPC and PET/CT will be performed

[68Ga]Ga-PentixaFor

[18F]Fluorodeoxyglucose

Pinyada Redlich

Andreas Buck, Prof. Dr.

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.

[68Ga]Ga-PentixaFor-PET Imaging for Staging of Marginal Zone Lymphoma

A Pivotal Phase 3 Clinical Trial to Assess the Diagnostic Performance and Safety of [68Ga]Ga-PentixaFor ([68Ga]Ga-PTF), a Positron Emission Tomography (PET) Imaging Agent, Versus [18F]FDG PET/CT Imaging, for Staging of Patients With Confirmed Marginal Zone Lymphoma Exemplary for CXCR4-positive Malignant Lymphomas: a Prospective, International, Multi-center, Comparative, Randomized, Cross-over, Open-label Lymphoma Diagnostic Trial

Sensitivity of \[68Ga\]Ga-PTF PET/CT imaging in detecting CXCR4 overexpressing tissue will be analyzed on a lesion-basis and will be confirmed by a CXCR4 SoT (CXCR4 IHC)

Specificity of \[68Ga\]Ga-PTF PET/CT imaging in detecting CXCR4 overexpressing tissue will be analyzed on a lesion-basis and will be confirmed by a CXCR4 SoT (CXCR4 IHC)

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

The safety and tolerability for each PET/CT imaging agent will be evaluated by the assessment of physical examination findings

The safety and tolerability for each PET/CT imaging agent will be evaluated by the assessment of blood pressure (systolic and diastolic)

The safety and tolerability for each PET/CT imaging agent will be evaluated by the assessment of heart or pulse rate

The safety and tolerability for each PET/CT imaging agent will be evaluated by the assessment of findings/abnormalities in the RR interval

The safety and tolerability for each PET/CT imaging agent will be evaluated by the assessment of PQ interval findings/abnormalities

The safety and tolerability for each PET/CT imaging agent will be evaluated by the assessment of QRS complex findings/abnormalities

The safety and tolerability for each PET/CT imaging agent will be evaluated by the assessment of QT interval findings/abnormalities

The safety and tolerability for each PET/CT imaging agent will be evaluated by the assessment of QTc interval findings/abnormalities

The safety and tolerability for each PET/CT imaging agent will be evaluated by the assessment of patient weight

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
[68Ga]Ga-PentixaFor-PET Imaging for Staging of Marginal Zone Lymphoma	NCT06125028	Marginal Zone L...	[68Ga]Ga-Pentix... [18F]Fluorodeox...	18 Years - 99 Years	Pentixapharm AG
[68Ga]Ga-PentixaFor-PET Imaging for Staging of Marginal Zone Lymphoma	NCT06125028	Marginal Zone L...	[68Ga]Ga-Pentix... [18F]Fluorodeox...	18 Years - 99 Years	Pentixapharm AG

Spots Global Cancer Trial Database for [18f]fluorodeoxyglucose